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Summer Travel 2022 – We’re Still in a Pandemic

     

In the best of times, summer travel can be a challenge, but for summer 2022, travel may be a bit more chaotic as the COVID-19 pandemic moves through unpredictable ups and downs.

Another COVID-19 Wave Kicks Off

Now in the third year of the COVID-19 pandemic, while it seemed that SARS-CoV-2 was moving toward endemicity, infections in the United States are again rising.1

One thing we do know about SARS-CoV-2 is that it is constantly changing. Although new variants are an expected part of the evolution of viruses, monitoring each one that surfaces is essential in ensuring we are prepared. This is especially true if a new variant is more aggressive, highly transmissible, vaccine-resistant, or able to cause more severe disease when compared with the original strain of the virus.2

COVID-19 Isn’t Quite Finished

There’s still a lot to learn about COVID-19, Omicron (BA.1) and its subvariants.

In February 2022, two new Omicron subvariants, BA.4 and BA.5, that originated in South Africa3 were classified by the European Centre for Disease Prevention and Control and the World Health Organization as variants of concern.3 As of July 2, 2022, BA.4 and BA.5 are estimated to make up a combined 70% of the coronavirus variants in the United States.2

Travelling During the COVID-19 Pandemic

If you choose to travel this summer, it’s best to plan ahead and take precautions to protect yourself and others against COVID-19.4 Travelers are reminded to follow the Centers for Disease Control and Prevention (CDC) travel guidance as well as local and state advisories regarding COVID-19.

Take Precautions to Protect Yourself from COVID-19

COVID-19 vaccinations remain the most effective tool in preventing severe illness, hospitalization, and death from COVID-19.5 But even if you’re vaccinated, it’s still a good idea to take precautions to protect yourself, family members, children and others while traveling during the COVID-19 pandemic.6

Effective June 18, 2022, the CDC endorsed a recommendation that all children 6 months through 5 years of age should receive a COVID-19 vaccine. Parents and caregivers can now get their children at least 6 months of age vaccinated with the Pfizer-BioNTech or Moderna vaccines to better protect them from COVID-19. According to the CDC, all children, including children who have already had COVID-19, should get vaccinated.7

The CDC recommends not to travel if you have COVID-19 symptoms, tested positive for COVID-19, are waiting for results of a COVID-19 test, had close contact with a person with COVID-19, or are recommended to quarantine.8 Travelers are reminded to follow CDC COVID-19 travel guidance if they have COVID-19 symptoms, are waiting for test results, or have been in contact with someone with COVID-19.

Testing and Treatment for SARS-COV-2 Infection

We must continue to protect ourselves from COVID-19 and use the tools that we have at our disposal to respond to this ongoing pandemic. If you or anyone feels unwell or exhibits any signs of COVID-19, it’s best to contact a healthcare provider right away to test and seek treatment for COVID-19. 12

Test to Treat

COVID-19 medications are now available through your doctor, local pharmacies, and health clinics.

The Test to Treat program gives people a fast and easy way to get lifesaving treatment for COVID-19. Adults and children of all ages can be tested at a site. People 12 years and older who weigh more than 88 pounds (40 kg) and have high-risk conditions may be eligible for treatment.13

On July 6, 2022, the FDA revised the Emergency Use Authorization for Pfizer’s PaxlovidTM, allowing state-licensed pharmacists to prescribe the antiviral treatment directly to eligible patients with certain limitations.21. The FDA also determined that Merck’s LagevrioTM should only be prescribed by healthcare prescribers, and not by pharmacists.22

If you test positive for COVID-19, you should first consider seeking care from your primary health care provider or through a one-stop Test to Treat site available nationwide at hundreds of pharmacy-based clinics and Health Resources and Services Administration supported federally qualified health centers.14

The Test to Treat program does not change existing requirements for qualified healthcare providers to write the prescriptions for these medications. People can continue to get tested and treated by their own healthcare providers, who can prescribe these medications to eligible patients. Patients can pick up those prescriptions wherever oral antivirals are distributed.15

If these medications are inappropriate for patients, additional COVID-19 drug options outside the Test to Treat program are available. The National Institutes of Health (NIH) has developed and regularly updates Treatment Guidelines to help guide healthcare providers caring for patients with COVID-19.16

Point of Care Molecular Testing

While there are many different types of tests that have emergency use authorization (EUA) in the United States, molecular diagnostics/nucleic acid amplification tests (NAAT), remain the gold standard for identifying SARS-CoV-2 infection.17

Talis OneTM: The Next Big Thing in COVID-19 Molecular Testing

At Talis, we believe that accurate POC molecular tests that can provide results in minutes instead of hours are needed to meet the need for fast, accurate testing. But not all POC NAATs deliver the same accuracy and sensitivity that central lab NAATs deliver18, which is why we developed the Talis One COVID-19 Test System for use under Emergency Use Authorization (EUA), to deliver central lab quality NAAT results quickly and in a variety of care environments.20

For Air Travellers to the U.S.A.

Effective as of June 10, 2022, the CDC will no longer require air passengers traveling from a foreign country to the United States to show a negative COVID-19 test result or documentation of recovery from COVID-19 before they board their flight. The CDC will re-evaluate this decision in 90 days and could reinstate the requirement for pre-departure testing if there are new concerns about another variant.9

As a reminder, the CDC still requires proof of COVID-19 vaccination for non-U.S. citizen, non-immigrant air passengers arriving from a foreign country to the United States by air.9

For Land Travel to the U.S.A.

Effective as of April 21, 2022, the Department of Homeland Security (DHS) extended requirements to non-U.S. travelers entering the United States via land ports of entry and ferry terminals at the U.S. Mexico and U.S. Canada borders to be fully vaccinated against COVID-19 and provide related proof of vaccination upon request. These requirements will continue to apply to non-U.S. travelers who are traveling both for essential and non-essential reasons, and do not apply to U.S. citizens, Lawful Permanent Residents, or U.S. nationals.10

Domestic Travel During COVID-19

If you plan to stay close to home, make sure you are up to date with your COVID-19 vaccines before travel and make sure you are aware of any travel restrictions in place at the state and local level.11

     

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COVID-19 Testing for Travel—What Your Patients Need to Know

Whether upcoming travel is for relaxation, business, or a combination of both, testing for COVID-19 is likely an integral part of the trip, especially when traveling by air. There are…

Join Our Newsletter

Subscribe to our newsletter for information about our products and company updates.


    TALIS BIOMEDICAL

    The GenBody COVID-19 Ag Test and the Talis One COVID-19 Test System are for use under Emergency Use Authorization (EUA) only. For In Vitro Diagnostic (IVD) use. For prescription use only. Talis is an authorized distributor of the GenBody COVID-19 Ag test.

    © Talis and Talis One are trademarks of Talis Biomedical Corporation. All Rights Reserved.

    *Additional testing solutions are currently in development and not available for sale.

    References

    1. COVID-19 in 2022—The Beginning of the End or the End of the Beginning? JAMA. Published online May 27, 2022. doi:10.1001/jama.2022.9655. https://pubmed.ncbi.nlm.nih.gov/35622357/. Carlos del Rio, MD1,2; Preeti N. Malani, MD, MSJ3,4
    2. Omicron, Delta, Alpha, and More: What To Know About the Coronavirus Variants. Originally published: Dec. 10, 2021. Updated: July 5, 2022. https://www.yalemedicine.org/news/covid-19-variants-of-concern-omicron. https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
    3. European Centre for Disease Prevention and Control. Epidemiological update: SARS-CoV-2 Omicron sub-lineages BA.4 and BA.5. 13 May 2022. https://www.ecdc.europa.eu/en/news-events/epidemiological-update-sars-cov-2-omicron-sub-lineages-ba4-and-ba5.
    4. COVID-19 Travel Recommendations. https://wwwnc.cdc.gov/travel/noticescovid19.
    5. Why to Get a COVID-19 Vaccine. https://www.cdc.gov/media/releases/2022/s0318-COVID-19-vaccines-protect.html
    6. Benefits of Getting A COVID-19 Vaccine. Updated June 19, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html
    7. CDC Recommends COVID-19 Vaccines for Young Children. https://www.cdc.gov/media/releases/2022/s0618-children-vaccine.html
    8. Travel. Updated June 13, 2022. https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html#:~:text=You%20have%20COVID%2D19%20symptoms,if%20you%20had%20no%20symptoms.
    9. CDC Travel. Updated June 13, 2022. https://www.cdc.gov/coronavirus/2019-ncov/travelers.
    10. CDC Travel; International. Updated June 13, 2022. https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel-during-covid19.html.
    11. DHS Extends COVID-19 Vaccination Requirements for Non-U.S. Travelers Entering the United States via Land Ports of Entry and Ferry Terminals. April 21, 2022. https://www.dhs.gov/news/2022/04/21/dhs-extends-covid-19-vaccination-requirements-non-us-travelers-entering-united.
    12. CDC-Public Health Professionals Gateway-Health Department Directories State & Territorial Health Department Websites. https://www.cdc.gov/publichealthgateway/healthdirectories/healthdepartments.html.
    13. CDC COVID-19. If You Are Sick or Caring for Someone. Updated Feb. 9, 2022. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/index.html.
    14. FDA Updates on Paxlovid for Health Care Providers. Content current as of 05/04/2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-updates-paxlovid-health-care-providers.
    15. Office of the Assistant Secretary for Preparedness and Response (ASPR). https://aspr.hhs.gov/TestToTreat/Documents/Fact-Sheet.pdf.
    16. New COVID-19 Test to Treat Initiative and Locator Tool. https://emergency.cdc.gov/newsletters/coca/040422.htm.
    17. NIH COVID-19 Treatment Guidelines. https://www.covid19treatmentguidelines.nih.gov/about-the-guidelines/guidelines-development/.
    18. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing. Published. 2021 Jan 22. https://pubmed.ncbi.nlm.nih.gov/33480973/. Hanson KE, Caliendo AM, Arias CA, et al.
    19. Diagnostics for SARS-CoV-2 infections. Nat Mater. Published 2021;20(5):593-605. https://pubmed.ncbi.nlm.nih.gov/33589798/. Kevadiya BD, Machhi J, Herskovitz J, et al.
    20. Evaluation of the Talis One™ Covid-19 Test System for the Rapid Detection of Sars-Cov-2 and Emerging Variants. Talis Whitepaper Fall 2021.
    21. Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations.
    22. FDA is letting pharmacists prescribe Pfizer’s Paxlovid but won’t do the same for Merck’s Lagevrio. https://www.fiercepharma.com/pharma/fda-letting-pharmacists-prescribe-pfizers-paxlovid-wont-do-same-mercks-lagevrio#:~:text=%E2%80%9CThe%20FDA%20has%20determined%20that,for%20provider%2Dpatient%20consultation.%E2%80%9D

    Sexually Transmitted Infections and Disease: the Silent Pandemic

         

    Twenty-five years ago, the Institute of Medicine (IOM) published a report on confronting sexually transmitted diseases (STDs) as the “hidden epidemic of tremendous health and economic consequence in the United States, and that the scope, impact, and consequences of STDs are under recognized by the public and in healthcare.”1

    Today, the United States is in the midst of a major sexually transmitted diseases (STDs) epidemic and public health crisis. Over the past decade, current recorded rates of STDs are at an all-time high2 with alarming increases in rates of sexually transmitted infections (STIs) of chlamydia, gonorrhea, and syphilis.

    A Pressing Public Health Challenge

    STDs are preventable—and infections are treatable. Many Americans largely underestimate the risk of STIs and for myriad reasons may not proactively seek care. Without diagnosis, testing, and treatment, the long-term health consequences of STDs are significant. The social stigma associated with STDs continues to complicate STD diagnosis, prevention, and treatment efforts, while access to care and social equity often factor in to approaches to reach groups at higher risk for contracting STDs.2

    Today, the STD epidemic still remains a critical public health challenge3 that disproportionately affects certain racial, ethnic, geographic, and socioeconomic groups. Such disparities in STD rates are complex to understand but may be rooted in a number of social factors such as poverty, unemployment, inadequate access to health care, lack of education, discrimination, social inequality, and cultural influences.4 While substantial progress has been made in preventing, diagnosing, and treating certain STDs in recent years, approximately 20 million new STI infections occur in the United States each year, with half of them occurring in adolescents and young adults ages 15–24.5

    What We Know About Sexually Transmitted Infections and Diseases

    STIs refer to a pathogen e.g., virus, bacteria, fungus, or parasite, that usually passes from one person to another through sexual contact, whereas the term STD refers to a recognizable disease state that has developed from an STI infection.6

    More than 30 different bacteria, viruses and parasites are known to be transmitted through sexual contact. Eight of these pathogens are linked to the greatest incidence of sexually transmitted disease. Of these, 4 are currently curable: chlamydia, gonorrhea, syphilis and trichomoniasis. The other 4 are viral infections which are incurable: hepatitis B, herpes simplex virus (HSV or herpes), HIV and human papillomavirus (HPV).7

    Reported Cases

    In 2019, U.S. health departments reported that cases of chlamydia, gonorrhea, and syphilis have increased for the sixth consecutive year – reaching a new, all-time high.8

    • 1.8 million cases of chlamydia, an increase of nearly 20 percent since 2015.
    • 616,392 cases of gonorrhea, an increase of more than 50 percent since 2015; and
    • 129,813 cases of syphilis (all stages), an increase of more than 70 percent since 2015.

    STDs During COVID-19

    Reported cases of STDs in the US decreased during the early months of the COVID-19 pandemic, but most had resurged by the end of 2020, with 2.4 million cases of STDs reported.Ultimately, reported cases of gonorrhea, syphilis, and congenital syphilis surpassed 2019 levels, while chlamydia declined.9

    In 2020,

    • 1,579,885 cases of chlamydia were reported to the CDC, making it the most common notifiable sexually transmitted infection in the United States for this year.9
    • 677,769 cases of gonorrhea were reported to the CDC, making it the second most common notifiable sexually transmitted infection in the United States for this year.9
    • Between 2019–2020, reported gonorrhea rates increased among both males and females in most racial/Hispanic ethnicity groups, with the greatest increases observed among non-Hispanic Black/African American persons and non-Hispanic persons of multiple races.9

    Social Determinants of Health: Know What Affects Health

    Social Determinants of Health (SDOH) are social and economic conditions such as poverty, stigma, housing, food insecurity, discrimination, racism, medical mistrust, violence/trauma, access to care, and education, that are considered the underlying, contributing factors of health inequities. Addressing these SDOH is a primary approach to help (a) achieve health equity, so everyone has the opportunity to attain their full health potential, and (b) prevent the disadvantages due to social position or other socially determined circumstance”.10

    What is Health Equity

    Health equity is achieved when everyone has an equal chance to be healthy regardless of their background race, ethnicity, income, gender, religion, sexual identity, and disability. Research shows that there are higher rates of STDs among some racial or ethnic minority groups compared to whites. It is important to understand that these higher rates are not caused by ethnicity or heritage, but by social conditions that are more likely to affect minority groups. Factors such as poverty, large gaps between the rich and the poor, fewer jobs, and low education levels can make it more difficult for people to stay sexually healthy.11

    Health Inequities and Disparities

    Social inequity often leads to health inequity and, ultimately, manifests as health disparities.12 It is important to recognize the negative impact that health disparities and inequities has that adversely impacts certain racial, ethnic, geographic, and socioeconomic groups access to receive quality healthcare, including STI testing, prevention, and treatment.13

    Testing Solutions to Ensure Healthcare Equity

    Numerous factors contribute to the persistent STI public health burden, but of particular importance is delay in treatment resulting from lengthy diagnostic protocols.14 Point-of-care (POC) tests offer many advantages regarding early diagnosis, detection, chronic disease screening, and infectious disease management as an important strategy to address the STIs in the United States. While access to care and confidentiality are major barriers to STI care, POC tests allow the clinician to provide patients with immediate and confidential test results, diagnosis, and treatment during the same appointment.15

    Tests for Chlamydia and Ghonorrhea

    The goal of screening sexually active adolescents and adults (including pregnant women), who are asymptomatic for chlamydia or gonorrhea, is to catch and treat infections that may present without symptoms, to prevent additional transmission and complications.16

    A Clear Need for Rapid Chlamydia and Ghonorrhea Tests

    Nucleic acid amplification tests (NAATs) are considered the gold standard for screening chlamydia and gonorrhea infections because their sensitivity and specificity are high for detecting these infections.17

    Most NAATs for chlamydia and gonorrhea must be performed in a central lab, requiring patients to return to their health care provider for treatment should the results be positive.

    By providing diagnostic tests that can be performed at the point of care, delivering test results within minutes, could help ensure more patients with chlamydia and gonorrhea are tested and receive treatment, potentially interrupting the transmission cycle.

    Bridging the Technology Gap

    At Talis, we are pioneering science and technology to diagnose infectious disease rapidly, accurately, and directly at the point of care. Fueled by excellence and clinical rigor, we’re developing a robust menu of tests to advance health equity and outcomes.

    One System, Multiple Applications

    With access to lab-quality molecular diagnostics at the point of need, clinicians get timely results for actionable decision making. In the future, our portfolio of point-of-care diagnostic tests will include solutions for multiple infectious disease states in a variety of settings.

    Learn more about our Talis One COVID-19 Instrument

    Meet the Talis One

    References

    1. Institute of Medicine Committee on Prevention and Control of Sexually Transmitted Diseases. The Hidden Epidemic: Confronting Sexually Transmitted Diseases, Summary. National Academies Press; 1997. eds. Washington, DC:   https://www.ncbi.nlm.nih.gov/books/NBK232935/. Eng. TR, Butler WT.
    2. National Academy of Public Administration; The STD Epidemic in America: The Frontline Struggle. November 19, 2019. http://www.ncsddc.org/wp-content/uploads/2019/11/NCSD-Phase-II-Final-Report.pdf
    3. Sexually Transmitted Diseases. https://www.healthypeople.gov/2020/topics-objectives/topic/sexually-transmitted-diseases
    4. Division of Epidemiology and Disease Prevention- Sexually Transmitted Diseases (STDs). https://www.ihs.gov/Epi/std/overview/.
    5. Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2018. Sexually Transmitted Diseases: April 2021 – Volume 48 – Issue 4 – p 208-214. https://pubmed.ncbi.nlm.nih.gov/33492089/. Kreisel KM, Spicknall IH, Gargano JW, Lewis FMT, Lewis RM, Markowitz LE, Roberts H, Johnson AS, Song R, St Cyr SB, Weston EJ, Torrone EA, Weinstock HS.
    6. Centers for Disease Control and Prevention (CDC) – Sexually Transmitted Diseases (STDs) – STI Treatment Guidelines, 2021. https://www.cdc.gov/std/treatment-guidelines/intro.htm.
    7. World Health Organization (WHO) – Sexually transmitted infections (STIs). https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis).
    8. Centers for Disease Control and Prevention (CDC). Sexually Transmitted Disease Surveillance 2019. https://www.cdc.gov/std/statistics/2019/infographic-html.htm.
    9. Centers for Disease Control and Prevention (CDC). Sexually Transmitted Disease Surveillance 2020. https://www.cdc.gov/std/statistics/2020/overview.htm#Disparities. https://www.cdc.gov/std/statistics/2020/overview.htm
    10. Centers for Disease Control and Prevention (CDC). NCHHSTP Social Determinants of Health. https://www.cdc.gov/nchhstp/socialdeterminants/faq.html#what-is-health-equity.
    11. Centers for Disease Control and Prevention (CDC). Health Equity. https://www.cdc.gov/healthequity/index.html.
    12. Sexually Transmitted Disease Surveillance, 2019. https://www.cdc.gov/std/statistics/2019/foreword.htm.
    13. U.S. Department of Health and Human Services. The Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020. Phase I report: Recommendations for the framework and format of Healthy People 2020 [Internet]. Section IV: Advisory Committee findings and recommendations [cited 2010 January 6]HealthyPeople.Gov. Foundation Health Measures – Foundation Health Measures Archive – Disparities. https://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities.
    14. “Point of care diagnostics for sexually transmitted infections: perspectives and advances.” Expert review of anti-infective therapy vol. 12,6 (2014): 657-72. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4065592/. Gaydos, Charlotte, and Justin Hardick.
    15. “What’s the Point? How Point-of-Care STI Tests Can Impact Infected Patients.” Point of care vol. 9,1 (2010): 36-46. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853950/. Huppert, Jill et al.
    16. United States Preventative Task Force (USPSTF) Chlamydia and Gonorrhea: Screening. September 14, 2021. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/chlamydia-and-gonorrhea-screening.
    17. Centers for Disease Control and Prevention (CDC). CDC. Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae — 2014. MMWR 2014;63(No. RR-2). Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae — 2014. https://www.cdc.gov/std/laboratory/2014labrec/default.htm.
         

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    Join Our Newsletter

    Subscribe to our newsletter for information about our products and company updates.


      TALIS BIOMEDICAL

      The GenBody COVID-19 Ag Test and the Talis One COVID-19 Test System are for use under Emergency Use Authorization (EUA) only. For In Vitro Diagnostic (IVD) use. For prescription use only. Talis is an authorized distributor of the GenBody COVID-19 Ag test.

      © Talis and Talis One are trademarks of Talis Biomedical Corporation. All Rights Reserved.

      *Additional testing solutions are currently in development and not available for sale.

      3 Lessons from the emergence of the SARS-CoV-2 Delta variant

           

      The emergence of the SARS-CoV-2 Delta variant highlights the importance of widespread vaccination and the ongoing need for accurate testing.

      New variants can quickly change the public health situation

      Positive developments related to the pandemic situation between the end of 2020 and early 2021 generated a great deal of hope. Multiple vaccines were starting to become available and by March 8, 2021, the CDC declared that fully vaccinated people could gather indoors without wearing masks.1 At that time, many believed that the worst of the pandemic was in the past. However, the emergence of the SARS-CoV-2 Delta variant significantly impacted the public health situation across much of the United States, with the CDC issuing new masking guidance and urging more people to become vaccinated in a July 27, 2021, announcement.2

      As we now know, the Delta variant is ~2x more contagious than previous variants,2-5 which has led to very rapid spread in areas with low vaccination rates.5 In the United States, the 7-day moving average of reported cases increased from ~12,000 in late June to ~60,000 by July 27.2 One of the main lessons the medical community can learn from the rapid spread of the Delta variant is how quickly a new variant can change the local public health situation from in to out of control. So how can we stop the emergence of new variants, one or more of which may be worse than Delta?

      Stopping the emergence of new variants requires controlling disease spread

      As with many viruses, the emergence of SARS-CoV-2 variants is the result of random errors introduced into the viral genome during replication.6 The best way to reduce the emergence of new variants is to limit virus replication by limiting transmission.7

      Variants are expected. The best way to slow the emergence of new variants is to reduce the spread of infection by taking measures to protect yourself, including getting a COVID-19 vaccine when available.7

      Until vaccination rates increase sufficiently to limit transmission, SARS-CoV-2 testing will continue to be needed

      Despite the effectiveness of vaccines in reducing the risk of death from SARS-CoV-2 and limiting disease spread, vaccine hesitancy remains a challenge.8,9 Given a vaccination level of ~55% of the total population in the United States,10 it seems plausible that we may see additional outbreaks from new variants, although Delta is the only variant of concern currently in the United States.11

      In addition, many scientists believe that COVID-19 is here to stay, becoming an endemic disease.12,13 Whether COVID-19, during its transition to endemicity, becomes a milder disease and/or a disease of the young,12,13 diagnostic testing will most likely continue to be an important tool for ensuring public health.

      The Talis One™ Instrument Delivers Accurate Molecular Testing at the Point of Care

      The Talis One COVID-19 Test System is conducted on the Talis One instrument which is designed to easily fit into a variety of care settings. The instrument is built to maximize health outcomes in the face of infectious disease threats, with an assay menu that will expand to include sexual and women’s health tests in the near future.

      Learn more about the Talis One COVID-19 Test System
           

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      Join Our Newsletter

      Subscribe to our newsletter for information about our products and company updates.


        TALIS BIOMEDICAL

        The GenBody COVID-19 Ag Test and the Talis One COVID-19 Test System are for use under Emergency Use Authorization (EUA) only. For In Vitro Diagnostic (IVD) use. For prescription use only. Talis is an authorized distributor of the GenBody COVID-19 Ag test.

        © Talis and Talis One are trademarks of Talis Biomedical Corporation. All Rights Reserved.

        *Additional testing solutions are currently in development and not available for sale.

        References

        1. CDC. CDC Museum COVID-19 Timeline. Centers for Disease Control and Prevention. Published August 4, 2021. Accessed August 23, 2021. https://www.cdc.gov/museum/timeline/covid19.html
        2. CDC. Coronavirus Disease 2019 (COVID-19). Delta Variant: What We Know About the Science. Centers for Disease Control and Prevention. Published February 11, 2020. Accessed September 24, 2021. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html
        3. Li B, Deng A, Li K, et al. Viral Infection and Transmission in a Large, Well-Traced Outbreak Caused by the SARS-CoV-2 Delta Variant.; 2021:2021.07.07.21260122. doi:10.1101/2021.07.07.21260122
        4. Wang Y, Chen R, Hu F, et al. Transmission, viral kinetics and clinical characteristics of the emergent SARS-CoV-2 Delta VOC in Guangzhou, China. EClinicalMedicine. 2021;40:101129. doi:10.1016/j.eclinm.2021.101129
        5. Bian L, Gao Q, Gao F, et al. Impact of the Delta variant on vaccine efficacy and response strategies. Expert Rev Vaccines.:1-9. doi:10.1080/14760584.2021.1976153
        6. Chen J, Wang R, Wei G-W. Review of the mechanisms of SARS-CoV-2 evolution and transmission. ArXiv. Published online September 15, 2021:arXiv:2109.08148v1.
        7. CDC. Coronavirus Disease 2019 (COVID-19). What you need to know about variants. Centers for Disease Control and Prevention. Published February 11, 2020. Accessed September 24, 2021. https://www.cdc.gov/coronavirus/2019-ncov/variants/variant.html
        8. Tram KH, Saeed S, Bradley C, et al. Deliberation, Dissent, and Distrust: Understanding Distinct Drivers of Coronavirus Disease 2019 Vaccine Hesitancy in the United States. Clin Infect Dis Off Publ Infect Dis Soc Am. Published online July 16, 2021:ciab633. doi:10.1093/cid/ciab633
        9. Siegler AJ, Luisi N, Hall EW, et al. Trajectory of COVID-19 Vaccine Hesitancy Over Time and Association of Initial Vaccine Hesitancy With Subsequent Vaccination. JAMA Netw Open. 2021;4(9):e2126882. doi:10.1001/jamanetworkopen.2021.26882
        10. CDC. COVID Data Tracker. Centers for Disease Control and Prevention. Published March 28, 2020. Accessed September 24, 2021. https://covid.cdc.gov/covid-data-tracker
        11. CDC. Coronavirus Disease 2019 (COVID-19). SARS-CoV-2 Variant Classifications and Definitions. Centers for Disease Control and Prevention. Published February 11, 2020. Accessed September 24, 2021. https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html
        12. Torjesen I. Covid-19 will become endemic but with decreased potency over time, scientists believe. BMJ. 2021;372:n494. doi:10.1136/bmj.n494
        13. Phillips N. The coronavirus is here to stay — here’s what that means. Nature. 2021;590(7846):382-384. doi:10.1038/d41586-021-00396-2

        Addressing Healthcare disparities in the US with Point-of-Care Testing

             

        Healthcare disparities in the US have become strikingly apparent throughout the COVID-19 pandemic, affecting historically underserved populations (e.g., lower-income households, Black and Minority Americans, immigrants, people with disabilities, rural populations, etc.). Point-of-care (POC) testing can help. To reduce the spread of infections and bring health equity forward, we need to take a closer look at POC testing and how to get it to communities that need it most.

        Healthcare disparities in the US at the point of care

        The rapidity of spread and mortality associated with the COVID-19 pandemic has shined a light on health disparities in the US. COVID-19 infection is higher among groups already affected by health disparities across age, race, ethnicity, language, income, and living conditions.1 Since the beginning of the pandemic, the top-third of vulnerable counties (defined by the COVID-19 vulnerability Index) have seen 21% more cases and 47% more deaths than the bottom-third of vulnerable counties, despite receiving 27% fewer tests.2 3

        One study found that transportation barriers are associated with significantly higher odds of a positive COVID-19 test, which suggests a greater risk of disease exposure associated with reliance on public transit and/or shared rides, or it may suggest inadequate access to health care, including timely COVID-19 testing.1 What’s more, COVID-19 has shifted the utilization of the American healthcare system where individuals are delaying or forgoing care—which can have serious and life-threatening health consequences. By June 2020, over 40% of U.S. adults reported that they delayed health care due to COVID-19 concerns.4

        Adding to these challenges is the threat of false negative COVID-19 test results, which could potentially lead to positive case clusters.5 6 When false negatives are suspected, individuals have to leave the facility and wait for their reflex testing results to become available. Ideally, individuals awaiting reflex testing results (as well as those who receive a positive COVID-19 test result) will quarantine, but this is not always possible, especially for those relying on public transportation and living in overcrowded housing facilities.

        Minimizing the time it takes to get accurate results and being able to communicate those results to patients quickly is paramount for minimizing community spread and delivering proper treatment. This supports the need for rapid and reliable testing, as well as in-visit test-to-answer POC workflows—especially for communities that have been shown to have less access to medical care and are less inclined to use telehealth service.

        What Point-of-Care Diagnostic Tests Should Look Like

        To drive health equity forward, we need diagnostic testing to be more accessible and reliable for underserved populations.

        Point-of-care diagnostics should enable rapid and effective test-to-treat workflows all in one visit

        Because underserved populations are more likely to miss appointments due to transportation and are more likely to have limited access to telehealth,7-10 it is imperative that these individuals get the information and treatment they need while they are in the testing facility. To confidently make treatment decisions during the same visit, point of care diagnostic tests should be sensitive without compromising speed and operational efficiency.

        Not only will test-to-treat workflows at the point of care help detect disease and deliver proper care earlier, but it can help minimize health care expenses due to missed appointments and hospitalization. This approach is stressed in the Sexually Transmitted Infections National Strategic Plan (2021-2025), where several objectives are discussed to ensure continuity of care. The plan touches on expanding personnel training to enhance screening, testing, and treatment capabilities within a single facility, specialized programs, and integrated and collaborative approaches in settings that serve communities disproportionately affected by STIs, HIV, and viral hepatitis.11

        The Talis Solution: A sample-to-answer test with central-lab quality sensitivity

        • The Talis One COVID-19 test enables quick and secure collection of samples for infectious disease testing
        • Talis One provides lab-quality molecular diagnostic results by utilizing innovative nucleic acid amplification technology integrated with solid-phase nucleic acid purification
        • Compared with up to several days of wait time for lab-run tests with similar accuracy, the Talis One solution delivers clear results in less than 30 mins

        Point-of-care diagnostics should be flexible enough to adapt to different environments and different communities

        Point-of-care locations can range from large pop-up centers in rural areas and places of work to metropolitan mobile clinics. Each community is unique, and POC tests need to be adaptable to the specific needs of the community. The instruments being used to detect SARS-CoV-2 should be space efficient for multiple types of facilities and, ideally, flexible enough to test for multiple infectious diseases and disease variants that are prevalent in the community being tested. This can save time for both the individual and the testing facility.

        As suggested by the Office of the Assistant Secretary of Health (OASH) and Office of Minority Health (OMH), to expand access to communities that are unable to access traditional testing sites, the federal government should partner with test kit manufacturers to develop SARS-CoV-2 test kits that are flexible enough to be used at the point of care or at-home and should establish and enforce policies that require public and private health insurance to cover SARS-CoV-2 testing to minimize financial barriers.12

        The Talis Solution:

        • Talis One is a complete, cost-effective solution that has potential for menu expansion to infectious diseases in respiratory and women’s health
        • With its small footprint and streamlined sample-to-answer workflow, Talis One can be used in a variety of point-of-care settings, enabling easy and broad access to testing for patients

        Point-of-care diagnostics should be easy-to-implement and easy-to-use

        Adopting new healthcare technologies is resource intensive—requiring a substantial amount of time for implementation and training. With healthcare personnel shortages increasing in underserved areas,13 it can be difficult to maintain an efficient operational workflow, or worse, patients cannot get the tests they need because there aren’t enough people to perform them. POC testing needs to be easy to implement and intuitive so that facilities can get up and running as quickly as possible and maintain efficiency through personnel changes.

        The Talis Solution:

        • Talis One’s user-centric workflow makes it easy to quickly begin testing in a variety of CLIA- waived healthcare settings
        • Talis provides on-demand support and training including access to educational resources and implementation guides

        Point-of-care diagnostics should have features that streamline reporting and communication to patients, labs and governing bodies

        Timely reporting is essential for sharing results, monitoring where outbreaks occur, tracking the incidence and prevalence of infection, and evaluating the impact of interventions. Not only can it help determine if a newly placed mobile clinic is effective and quickly get test results to patients, but it also enables proper allocation of critical resources to those in greatest need.

        The Talis Solution:

        • Talis One has cloud connectivity that easily integrates with LIS and EMR systems
        • Results from the Talis One molecular tests are delivered as easy-to-understand reports
        • With sample-to-answer workflow, Talis One enables caregivers to communicate results to patients within 30 minutes

        Moving Towards Health Equity with Point-of-Care Testing

        With the CDC planning to invest $2.25 Billion to address COVID-19-related health disparities and advance health equity among populations that are at high-risk and underserved,14 there is no better time than now to evaluate and adopt a new POC testing solution.

        To ensure there is timely and equitable access to testing with rapid return of results in communities disproportionately affected by COVID-19, we need to consider the recommendations outlined by the CDC:1 5

        • Use a social vulnerability index16 to help select testing sites
        • Review the groups to prioritize for screening testing
        • Carefully consider the different types of SARS-CoV-2 tests when planning for diagnostic or screening use

        By providing easy access to actionable results at the point-of-care in public health settings, the Talis One molecular testing solution empowers you to quickly and confidently diagnose infections, promote safety and peace of mind for your patients, and ultimately combat healthcare disparities in the US.

        Learn More
             

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        Subscribe to our newsletter for information about our products and company updates.


          TALIS BIOMEDICAL

          The GenBody COVID-19 Ag Test and the Talis One COVID-19 Test System are for use under Emergency Use Authorization (EUA) only. For In Vitro Diagnostic (IVD) use. For prescription use only. Talis is an authorized distributor of the GenBody COVID-19 Ag test.

          © Talis and Talis One are trademarks of Talis Biomedical Corporation. All Rights Reserved.

          *Additional testing solutions are currently in development and not available for sale.

          References

          1. Rozenfeld, Yelena, et al. “A model of disparities: risk factors associated with COVID-19 infection.” International journal for equity in health 19.1 (2020): 1-10.
          2. Bringing Greater Precision to the COVID-19 Response. (2020, December). Retrieved July 01, 2021, from https://precisionforcovid.org/ccvi
          3. Smittenaar, P., Stewart, N., Sutermaster, S., Coome, L., Dibner-Dunlap, A., Jain, M., … & Sgaier, S. K. (2021). A COVID-19 Community Vulnerability Index to drive precision policy in the US. medRxiv.
          4. Czeisler, Mark É., et al. “Delay or avoidance of medical care because of COVID-19–related concerns—United States, June 2020.” Morbidity and mortality weekly report 69.36 (2020): 1250.
          5. False negative rate of COVID-19 PCR testing: A discordant testing analysis. (2021, January 9). Retrieved July 01, 2021, from https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01489-0
          6. Cao G, Tang S, Yang D, Shi W, Wang X, Wang H, et al. The potential transmission of SARS-CoV-2 from patients with negative RT-PCR swab tests to others: two related clusters of COVID-19 outbreak. Jpn J Infect Dis. 2020. https://doi.org/10.7883/yoken.JJID.2020.165.
          7. Samuels, R. C., Ward, V. L., Melvin, P., Macht-Greenberg, M., Wenren, L. M., Yi, J., … & Cox, J. E. (2015). Missed appointments: factors contributing to high no-show rates in an urban pediatrics primary care clinic. Clinical pediatrics, 54(10), 976-982.
          8. Fischer, S. H., Ray, K. N., Mehrotra, A., Bloom, E. L., & Uscher-Pines, L. (2020). Prevalence and characteristics of Telehealth utilization in the United States. JAMA network open, 3(10), e2022302-e2022302.
          9. Pierce, R. P., & Stevermer, J. J. (2020). Disparities in use of telehealth at the onset of the COVID-19 public health emergency. Journal of telemedicine and telecare, 1357633X20963893.
          10. Vogels, E. (2021, June 22). Digital divide persists even as Americans with lower incomes make gains in tech adoption. Retrieved July 01, 2021, from https://www.pewresearch.org/fact-tank/2021/06/22/digital-divide-persists-even-as-americans-with-lower-incomes-make-gains-in-tech-adoption/
          11. U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. Washington, DC.
          12. COVID-19 Health Equity Task Force: Long COVID, PPE, Testing and Therapeutics Subcommittee Interim Recommendations. (2021, June 25). Retrieved July 01, 2021, from https://www.minorityhealth.hhs.gov/Assets/PDF/June-COVID19HETFSubcommitteesRecommendations-062521-508.pdf
          13. Malayala, Srikrishna Varun, et al. “Primary care shortage in medically underserved and health provider shortage areas: Lessons from Delaware, USA.” Journal of Primary Care & Community Health 12 (2021): 2150132721994018.
          14. CDC announces $2.25 billion to address Covid-19 health disparities in communities that are at high-risk and underserved. (2021, March 17). Retrieved July 01, 2021, from https://www.cdc.gov/media/releases/2021/p0317-COVID-19-Health-Disparities.html
          15. Overview of Testing for SARS-CoV-2 (COVID-19). (2021, March 17). Retrieved July 01, 2021, from https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
          16. CDC/ATSDR Social Vulnerability Index. (2021, April 28). Retrieved July 01, 2021, from https://www.atsdr.cdc.gov/placeandhealth/svi/index.html

          SARS-COV-2 Variants and Their Impact on Molecular Tests

               

          As new variants of SARS-CoV-2 arise, they can impact diagnostic testing, potentially resulting in false negative results. To confidently make treatment decisions, achieve best-possible patient outcomes, and drive operational and clinical efficiency in a point-of-care setting, you need highly sensitive, rapid molecular tests capable of detecting all existing and emerging SARS-CoV-2 variants.

          Which SARS-CoV-2 Tests Are Susceptible to False Negatives?

          Molecular tests are straightforward to design for pathogen detection because they are largely based on an RNA sequence. However, viruses that rapidly evolve, such as SARS-CoV-2, can influence test sensitivity based on the sequence of the variant, the design of the test and the prevalence of the variant in the population.

          Earlier this year, the FDA identified four EUA-authorized molecular tests that could be impacted by SARS-CoV-2 genetic variants, such as the B.1.1.7 variant that has been associated with an increased risk of transmission.1-2

          It is important to be aware that genetic variants are expected to continue to emerge in SARS-CoV-2, which can threaten the sensitivity of virtually any molecular test. This is due to the possibility that one of the targets is driving the sensitivity, so that even if the others still match perfectly the sensitivity can be reduced based on a mutation in a single target. By choosing a test that uses multiple genetic targets, a test will be less likely to be impacted by increased prevalence of genetic variants.3

          How To Know If SARS-CoV-2 Variants Impact Your Molecular Test?


          Consider the patterns of detection
          for your specific test. By choosing a test that uses multiple genetic targets, unfamiliar patterns may reveal the presence of new variants without impacting the final result of your test.

          Stay up-to-date on emerging SARS-CoV-2 variants4, and their ability to evade detection by specific viral diagnostic tests.

          Perform a repeat test. Per FDA recommendations5, consider negative results in combination with clinical observations, patient history and epidemiological information and repeat testing with a different test targeting different genetic regions if COVID-19 is still suspected.

          How Do SARS-CoV-2 Molecular Tests Perform at the Point-of-Care?


          All molecular tests used at the point-of-care are significantly faster than central-lab molecular tests 

          Compared with central lab molecular tests, which may take up to several days, many point-of-care (POC) molecular test results are generated in up to 45 minutes6.

          Point-of-care molecular tests integrated with nucleic acid extraction are more sensitive than those without this crucial sample preparation step

          Not all POC molecular tests are created equal. There are some that incorporate nucleic acid extraction (e.g., Talis One) and many that do not, and this feature appears to influence the sensitivity of the test.7 Tests integrated with nucleic acid extraction can deliver significantly lower limits of detection (LoD)—with Talis One sensitivity approaching the range of lab-quality tests.7 Confirmatory testing for presumptive negatives may not be required.

          Talis One provides rapid and accurate SARS-CoV-2 detection—quickly delivering central lab-quality results at the point of care

          At Talis, we strive to use the best technology to bring the precision of lab-based molecular testing to the point-of-care. The Talis One Covid-19 Test System is designed to detect the ORF1ab and N gene (highly conserved regions) to remain sensitive in the presence of new variants and minimize the need for repeat testing. By integrating solid-phase extraction with innovative nucleic acid amplification technology, the Talis One COVID-19 Test System provides a sample-to-answer POC test where clear, actionable, highly sensitive results are generated in less than 30 minutes—helping healthcare providers enhance patient experience and patient outcomes.

          Confidently determine who needs to quarantine and be treated to achieve better patient outcomes with the Talis One COVID-19 Test. 

          Talis One COVID-19 Test System

          Central lab-quality SARS-CoV-2 molecular testing for a variety of care settings—less than 30 minutes from sample to results.

          Learn More
               

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            TALIS BIOMEDICAL

            The GenBody COVID-19 Ag Test and the Talis One COVID-19 Test System are for use under Emergency Use Authorization (EUA) only. For In Vitro Diagnostic (IVD) use. For prescription use only. Talis is an authorized distributor of the GenBody COVID-19 Ag test.

            © Talis and Talis One are trademarks of Talis Biomedical Corporation. All Rights Reserved.

            *Additional testing solutions are currently in development and not available for sale.

            References

            1. SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. U.S. Food and Drug Administration website. Updated June 3, 2021. Accessed June 25, 2021. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests
            2. Emergence of SARS-CoV-2 B.1.1.7 Lineage — United States. Centers for Disease Control and Prevention website. Updated January 22, 2021. Accessed June 25, 2021.https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e2.htm
            3. SARS-CoV-2 E Gene Variant Alters Analytical Sensitivity Characteristics of Viral Detection Using a Commercial Reverse Transcription-PCR Assay https://journals.asm.org/doi/full/10.1128/JCM.00075-21 Accessed August 12, 2021
            4. Genetic Variants of SARS-CoV-2 May Lead to False Negative. U.S. Food and Drug Administration website. Updated March 30, 2021. Accessed June 25, 2021. https://www.fda.gov/medical-devices/letters-health-care-providers/genetic-variants-sars-cov-2-may-lead-false-negative-results-molecular-tests-detection-sars-cov-2
            5. Science Brief: Emerging SARS-CoV-2 Variants. Centers for Disease Control and Prevention website. Updated January 28, 2021. Accessed June 25, 2021. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-emerging-variants.html
            6. Manufacturers’ instructions for use accessed August 12, 2021 at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-molecular
            7. Subsoontorn, P., Lohitnavy, M. & Kongkaew, C. The diagnostic accuracy of isothermal nucleic acid point-of-care tests for human coronaviruses: A systematic review and meta-analysis. Sci Rep 10, 22349 (2020). https://doi.org/10.1038/s41598-020-79237-7 Accessed August 12, 2021