Trends in Infectious Disease Diagnostics

Driven by the global prevalence of infectious diseases, the worldwide infectious disease diagnostics market is expected to reach nearly $40 billion by 2026.1 That growth has been accelerated by the pandemic, which has driven Emergency Use Authorizations (EUAs) of over 430 different tests and collection kits for SARS-CoV-2.2

As we transition from pandemic response to endemic management, development of next-generation diagnostics for infectious diseases, including COVID-19, is seeing innovation driven by demand for at-home testing, assays with predictive or prognostic capabilities, and multi-pathogen tests. More broadly, the uptick in awareness and adoption of at-home diagnostics has added momentum to a direct-to-consumer (DTC) trend that started with DNA test kits more than a decade ago.

At-Home Testing

According to former United States Food and Drug (FDA) Commissioner Scott Gottlieb, MD, the pandemic “has changed our culture around healthcare and changed our orientation to aspects of healthcare delivery that are fundamental.”3 Two decades ago, home human immunodeficiency virus (HIV) testing sparked vigorous debate within the FDA due to concern over whether patients who self-diagnose for infectious disease would seek appropriate follow-up.3 Now, the agency has embraced at-home testing.

Prior to the pandemic, home HIV tests were the only FDA-approved, fully at-home infectious disease diagnostic.4 Enabled by a flexible regulatory framework and the FDA’s emphasis on tests that could be utilized outside of laboratory or healthcare settings, COVID-19 diagnostics evolved quickly from hospital-based tests to point-of-care platforms. Rapid, scalable pandemic response necessitated a shift from centralized laboratories to healthcare and home settings for population-level testing, accelerating the adoption of point-of-care products. As of May 10, 2022, the FDA has authorized2,5

  • 78 tests and collection kits using samples that are collected at home and then sent to a lab for processing
  • 3 prescription at-home tests which can be fully administered and analyzed at home
  • 20 over the counter (OTC) fully at-home tests

Precision for Medicine supported the development and/or regulatory strategy and execution of many of these diagnostics, including preparation and submission of an EUA application for a first-of-its-kind home rapid antigen test paired with a mobile app. The use of a smartphone to deliver digital results is an example of the innovation we expect to see as healthcare in the home becomes even more commonplace.

In January 2022, the FDA gave 510(k) clearance to the BioFire COVID-19 Test 2.6 More recently, the FDA has been encouraging diagnostics developers with EUAs to seek authorization through the traditional premarket review process to ensure their products can be marketed beyond the public health emergency.7

Prior to the pandemic, companies such as EverlyWell were already gaining traction in the DTC health market with at-home health and wellness product offerings, including collection kits for infectious diseases such as chlamydia and gonorrhea, syphilis, hepatitis C, HIV, human papillomavirus, and trichomoniasis. Multi-pathogen sexually transmitted infection (STI) laboratory tests based on at-home sample collection are becoming increasingly available from a number of manufacturers, though none are yet approved by the FDA.8

What is clear is that regulatory frameworks are quickly evolving to keep up with this innovation, so diagnostic developers need to keep a close watch on changes. For example, the recent recall of the Ellume COVID-19 Home Test due to a high false-positive rate prompted the FDA to take steps to increase the accuracy and reliability of at-home tests.9

Precision for Medicine has a team dedicated specifically to the regulatory landscape for diagnostics, supporting clients involved in developing and commercializing diagnostics. You can learn more at www.PrecisionforMedicine.com.

Predictive and Prognostic Tests

While tests to diagnose infection have played the most prominent role in infectious disease control, predictive and prognostic tests are critical for identifying those at risk of rapid decline and the likely course of the disease. For COVID-19, the success of this next phase of diagnostic development will rely on the identification of biomarkers that can be used to

  • Assess the efficacy of vaccines and therapeutics
  • Identify and prevent clinical complications
  • Stratify patients to the most appropriate treatments

At Precision for Medicine, our specialty laboratories are contributing to the study of immune cell response in SARS-CoV-2 to support diagnostic development.

The next-generation of infectious disease diagnostics will rely on a combination of multiple biomarkers—including molecular, immunological, clinical, and imaging biomarkers—and predictive algorithms. Already, advanced bioinformatics approaches are being applied to large multiomic data sets to search for predictive and prognostic biomarker signatures. Precision for Medicine is supporting the development of technologies that will bring these approaches into the clinic, such as Inflammatix’s InSep™️, a 29-mRNA classifier test that has demonstrated utility in predicting severity of infection.

Multi-Pathogen Testing

Multi-pathogen tests are expected to become part of the diagnostic landscape in the near future. Evidence of such is the recent FDA authorization of 19 multi-analyte tests that detect SARS-CoV-2 and other respiratory viruses.2 In March 2021, the agency granted the first marketing authorization using the de novo review pathway for the BioFire Respiratory Panel 2.1, which was initially authorized for emergency use in May 2020. As the first SARS-CoV-2 diagnostic approved for use following the public health emergency, this panel enables simultaneous detection and identification of multiple respiratory, viral, and bacterial nucleic acids.10 This approval was also significant as it paves the way for other multi-pathogen tests, including those that can help distinguish among respiratory infections to guide treatment.

As influenza cases reached an all-time low last year, the Centers for Disease Control and Prevention (CDC) has warned that immunity against influenza may be reduced during what is expected to be an early and possibly severe flu season this year. With the return to work, school, and large gatherings, combination tests will be crucial for detecting highly contagious viral infections which may otherwise have gone untested, thereby limiting awareness to prevent transmission.

Impact on the Broader Infectious Disease Diagnostics Market

Recently, the American Society for Microbiology examined the impact of SARS-CoV-2 testing on laboratory-based testing of other infectious diseases of health importance, such as healthcare associated infections (HAIs) and STIs. They found that11

  • Mobilization of personnel and resources to support COVID-19 response delayed diagnosis of non–COVID-19 respiratory infections
  • The ability of laboratories to perform HAI and antimicrobial susceptibility testing was adversely affected by testing shortages
  • The pandemic may be contributing to the spread of antimicrobial resistance
  • STI testing dropped due to decreased clinic capacity, affecting downstream patient care and delaying epidemiological intervention

These findings highlight opportunities for self-collection and self-testing solutions to impact consumer and public health.

New sampling technology, fully automated molecular diagnostic systems, rapid multiplex testing, and advanced digital capabilities have changed how and where testing is done. The push toward DTC, at-home testing is being driven not only by traditional diagnostics developers, but also digital health companies seeking to disrupt traditional laboratory-based testing processes.

Conclusion

COVID-19 has ushered in a new era of infectious disease diagnostics innovation, accelerating progress in point-of-care testing methods and rapid, home-based diagnostic tests that are available over the counter. Pandemic-related learnings now provide a predicate for other infectious diseases, such as STIs, where self-testing offers convenience and privacy, though regulatory frameworks will need to evolve to ensure safety and utility that is on par with laboratory-based tests.

At Precision for Medicine, we support diagnostics developers throughout the development lifecycle through the provision of high-quality biospecimens, both diseased and normal; specialty lab services for assay validation; clinical trial solutions; and regulatory and market-access support.

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1Markets and Markets. Infectious Disease Diagnostics Market by Product (Reagents, Assays, Instrument, Software), Test (Lab, POC), Disease (COVID-19, Flu, HAIs, HIV, HPV), Technology (Immunodiagnostics, NGS, INAAT, PCR), End User (Hospitals, Labs) - Global Forecast to 2027. Available at https://www.marketsandmarkets.com/Market-Reports/infectious-disease-diagnostics-market-116764589.html.

2U.S. Food and Drug Administration. FDA Roundup: May 10, 2022. Available at https://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2022.

3Managed Healthcare Executive. Gottlieb: COVID-19's Lasting Effects on Healthcare Delivery, September 13, 2021. Available at https://www.managedhealthcareexecutive.com/view/gottlieb-covid-19-s-lasting-effects-on-healthcare-delivery.

4The Johns Hopkins Center for Health Security. At-Home Diagnostic Testing for Infectious Diseases: A Tool for Accelerating COVID Diagnosis and Building Pandemic Preparedness for the Future, June 25, 2020. Available at https://www.centerforhealthsecurity.org/our-work/publications/at-home-diagnostic-testing-for-infectious-diseases.

5U.S. Food and Drug Administration. At-Home OTC COVID-19 Diagnostic Tests, Content Current as of May 13, 2022. Available at https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list.

6U.S. Army Medical Material Development Activity. USAMMDA Announces FDA 510 (k) Clearance of Rapid Diagnostic Test for COVID-19. Available at https://www.usammda.army.mil/index.cfm/public_affairs/articles/2022/usammda_rapid_diagnostic_test_for_covid_19.

7MedTech Dive. FDA urges COVID-19 test makers with EUAs to seek full authorizations, March 24, 2022. Available at https://www.medtechdive.com/news/fda-urges-covid-19-test-makers-euas-seek-full-authorization/620940/.

8Everlywell. Our Home Health Tests. Available at https://www.everlywell.com/products/.

9U.S. Food and Drug Administration. FDA News Release Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests, November 15, 2021. Available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-test-policies-help-ensure-accuracy-and-reliability-tests-and.

10U.S. Food and Drug Administration. FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process. Available at https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-sars-cov-2-diagnostic-test-using-traditional-premarket-review-process.

11American Society for Microbiology. Pandemic Lab Woes and Patient Fears Affect Other Infectious Diseases, July 22, 2021. Available at https://asm.org/Articles/2021/July/Pandemic-Lab-Woes-and-Patient-Fears-Affect-Other-I.

Precision for Medicine

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Karen Richards, RAC
Senior Vice President,
IVD Regulatory & Quality Consulting