Book:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/The clinical environment/CLIA market and industry trends

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1.8 CLIA market and industry trends

1.8.1 Clinical laboratory testing trends

With over 13 billion laboratory tests performed in the United States every year, laboratory testing is the highest volume medical activity in the country.[1][2] Laboratory testing influences approximately two-thirds of all medical decisions, and this testing often directs far more expensive care.[1] As these trends continue, the laboratory will likely become a coordinator for the patient and care team. The laboratory will serve as a facilitator for the patient and clinicians alike to receive not only test results but also education about those results. The laboratory will also assist the clinical team with test utilization, reporting those results into the EHR as well as maintaining them.[1]

Laboratory testing is in an upward trend, as seen with the growth of point-of-care testing and the patient-centered medical home (PCMH). Given the popularity of consumer products that track healthcare data, this trend should continue for years to come. One example of this is VeinViewer, which assists the phlebotomist with the location of veins and eliminates the painful process of sticking a patient more than once in an attempt to draw blood.[3] Other technologies are driving trends in this area, including in the testing domain, where for example Healthy.io (which acquired Scanadu/inui Health in 2020) offers a urinalysis strip than can be analyzed with a mobile app.[4][5]

1.8.2 POL testing trends

The third installment of research firm Kalorama Information's Physician Office Laboratory Markets reported the number of POLs performing CLIA-waived in vitro diagnostic (IVD) testing increased an average annual rate of 3.8 percent from 2005 to 2013, though "the number of POLs conducting moderate- and high-complexity testing under CLIA compliance or accreditation decreased by an annual average rate of 0.8 percent."[6] In mid- to late 2014, Kalorama estimated that POLs were conducting nine percent of all clinical IVD testing in the United States, also noting that "[n]ine out of the ten most-performed POL tests in the United States are CLIA-waived."[7]

As for what's being tested, the report noted that "[i]n the past five years, the most performed POL tests have changed little with the exception of some recently CLIA-waived infectious disease tests and vitamin D testing."[6] The study also found that many of the CLIA waivers granted in 2014 have been for tests in "highly competitive, established POL segments, such as drugs-of-abuse testing, routine clinical chemistries, urinalysis, hormone tests (including pregnancy), and dipstick urinalysis."[8] Many of those IVD tests were likely waived by regulation or cleared for home or over-the-counter use; however, a few of those tests had to go through a more rigorous process to become CLIA-waived.

Kalorama Information hasn't released a POL-specific report since 2014, but some information can be gleaned from other sources. In 2020, market research from Health Industry Distributors Association (HIDA) reported that POCT was outpacing overall diagnostic markets, and that molecular diagnostics is one of the fastest growing lab subspecialties.[9] This matches Thill's 2020 assessment that molecular diagnostics testing is becoming more readily available to the POL.[10] Thill also highlights the potential for PPM testing to make a comeback in the POL after nearly a decade of the percentage of labs performing PPM and other forms of moderate testing dropping. Writing for Repertoire magazine, Thill envisions those numbers slowly increasing again in the future, particularly given the rapid technological developments in molecular diagnostics testing, shifting some CLIA moderate molecular tests to waived, and other high-complexity molecular test to moderate. POLs wanting to perform more COVID-19 testing for their patients may also be a motivating factor to move up to CLIA moderate testing. This move to moderate may also be compelling to larger physician practices of five or more physicians wanting to conduct a higher throughput of both waived and moderate testing.[10]

1.8.3 Addition of the Dual 510(k) and CLIA Waiver by Application process

Originally an IVD test product not CLIA-waived by regulation or not cleared for home or over-the-counter use—even if it had clear advantages as a CLIA-waived product—would have to first be taken through the FDA 510(k) premarketing submission process which would then classify it as moderate or high complexity.[11] Then, if the product was viable as a moderate complexity device, the manufacturer would try to market and make money on their product and then go through the CLIA Waiver by Application process if they thought there were clear benefits and eligibility for CLIA-waived product status. By 2014, this process worked well enough for many manufacturers but frustrate a few who deemed their product non-viable to market unless it were CLIA-waived.[12]

Initially driven by the Medical Device User Fee Amendments of 2012 (MDUFA III)—an FDA attempt "to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market"[13]—the FDA sought to overhaul its Administrative Procedures for CLIA Categorization guidance documents, tracking mechanisms, and public CLIA database to improve the IVD and medical equipment regulation process. Among these changes, effective March 21, 2014, was the addition of the Dual 510(k) and CLIA Waiver by Application process, specifically for "that small subset of products that are not really viable if they are not waived."[12][14][15] The process is specific, requiring a pre-submission to receive FDA feedback first and be cleared for the Dual strategy. If approved, both the 510(k) and the CLIA Waiver by Application can be submitted at the same time.[12][11][16]

On December 17, 2014, rapid diagnostic manufacturer Quidel Corporation announced its Sofia Strep A+ Fluorescent Immunoassay, which became the first product to be approved through the Dual program[17], opening a potential gateway for other rapid diagnostic companies to fast-track their product through FDA and CLIA waiver approval. By 2020, more finalized reforms to the Dual program clarified the submission process, with the FDA stating, "Use of the dual 510(k) and CLIA waiver by application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver and at the same time as 510(k) clearance."[18] The FDA released its finalized guidance Recommendations for Dual 510(k) and CLIA Waiver by Application Studies in February 2020[19], which helped clarify their stance.

1.8.4 More sophisticated CLIA-waived tests appear

Man undergoes a COVID-19 swab test E.jpg

Since the mid-2010, more sophisticated tests eligible for labs with a certificate of waiver have been appearing, further increasing same-day testing opportunities in POLs. For example, the first ever waived rapid screening test for syphilis was approved in the United States in December 2014, allowing physicians to make a preliminary diagnosis in as soon as 12 minutes. The product came about with the recognition of a the increasing number of primary and secondary syphilis cases in the U.S., nearly 55,000 new cases a year.[20] In 2015, reportedly almost four percent of all approved CLIA-waived tests were HIV tests, and of labs that offered CLIA-waived testing in general, 36 percent of them included at least one CLIA-waived HIV test.[21]

One of the biggest changes in the mid-2010s was the anticipation for waived molecular and nucleic acid-based testing. In an April 2015 interview with GenomeWeb, Cepheid chairman and CEO John Bishop stated the company would be "adding a sales force specifically for the CLIA market in early May" with expectations that the "market is actually going to step up overall test volumes as you move more broadly-disseminated."[22] Alere was also making a similar focus, though both companies were arguably heading up the charge towards a new potential trend in the CLIA-waived testing market: molecular and nucleic acid-based testing.

"I think the molecular tests are going to grab market share very rapidly ... and that's going to get even more emphasized with all of the programs now on antibiotic stewardship and more diagnostically directed use of therapeutics."[22] - John Bishop, Cepheid, Inc. chairman and CEO

"[W]e look forward to kind of changing the concept in the marketplace, [and showing] that you can get a highly sensitive, molecular result in minutes."[23] - K.C. McGrath, Alere, Inc. respiratory product manager

"We expect many other simple and accurate tests using nucleic acid-based technology to be developed in the near future. Once cleared by FDA, such tests can allow health care professionals to receive test results more quickly to inform further diagnostic and treatment decisions."[24] - Alberto Gutierrez, FDA director of the Office of In Vitro Diagnostics and Radiological Health

"I think traditional [polymerase chain reaction] assays will get better, faster, their boxes will get smaller, and you'll start to see a lot more point-of-care approved tests."[25] - Christine Ginocchio, BioMérieux vice president of global microbiology affairs

Molecular diagnostic tests had long been the domain of the full-fledged laboratory, even as companies like Cepheid made progress with sales of its molecular Flu Xpert test[22], rated by CLIA for moderate complexity labs.[26] With only roughly 29 percent of POLs running at some level of moderate complexity or better[27], however, molecular testing seemed largely out-of-reach for the POL. However, in January 2015, Alere and the FDA announced that the i Influenza A & B test had become the first ever nucleic acid-based test to receive CLIA-waived status, meaning it could be offered in POLs with a certificate of waiver.[26][24] Of course, not only were molecular tests beginning to make appearances for testing respiratory afflictions like influenza, but the COVID-19 pandemic thrust waived molecular testing into the spotlight full-force. As of April 2022, nearly 20 CLIA-waived COVID-19 molecular tests—some approved for home use—were available under emergency use authorization (EUA).[28] Molecular-based sexually transmitted infection (STI) testing has also seen an uptick[29], highlighting the growing sophistication of waived tests available to POLs. In another example, in the spring of 2021, Binx Health became the first to have a CLIA-waived molecular chlamydia and gonorrhea POCT on the market.[30]

1.8.5 Other players in the CLIA market

Other entities have applied their focus to the CLIA market as well. Take AmericanBio, a custom reagent manufacturer that announced in October 2014 that it was implementing a "CLIA Grade product line and CLIA Grade Custom Manufacturing Services," helping device manufacturers sort through "regulatory framework, validation needs, consistency, and quality driven metrics that will support their diagnostic tool," both traditional and molecular.[31] Seminars and webinars about getting medical devices CLIA-waived by market research companies like Research and Markets and government agencies like the National Institutes of Health became more prominent in the mid-2010s also.[32][33] And niche businesses like MRI Global have popped up, offering specialty regulatory, device, and test development services for the CLIA market.[34]

One other growing player in the CLIA market is the pharmacy-based laboratory. Since June 2011, POLs have lost ground to pharmacy-based labs, which have gone from making up 2.7 percent of all labs in June 2011[35] to 8.0 percent in May 2022.[36] Though these numbers were growing before the COVID-19 pandemic, it likely only helped boost the pharmacy lab and its efforts to perform lab testing.[37] Writing for 360 Dx, Adam Bonislawski notes that "[p]harmacy testing is done within pharmacies themselves, which are allowed to offer CLIA-waived tests provided they are registered as CLIA-waved laboratories."[37] With the previously mentioned EUAs on CLIA-waived COVID-19 tests, this further emboldened pharmacy labs to muscle in on POL territory to the point of making pharmacies only second to POLs in CLIA-waived testing. However, like POLs, the question of the reimbursement of these other CLIA-waived tests (see next section) remains, not to mention the question of whether or not the POL has the better advantage to providing service at the point of care.[37]

References

  1. ↑ 1.0 1.1 1.2 "Integrating Laboratories Into the PCMH Model of Health Care Delivery: A COLA White Paper" (PDF). 2014. p. 3–4. http://www.cola.org/wp-content/uploads/2015/06/COLA_14194-PCMH-Whitepaper.pdf. Retrieved 20 April 2022. 
  2. ↑ "Strengthening Clinical Laboratories". Centers for Disease Control and Prevention. 15 November 2018. https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html. Retrieved 20 April 2022. 
  3. ↑ Goyal, Nidhi (4 April 2015). "VeinViewer Means No More Poking People Relentlessly to Locate Veins". Industry Tap. https://www.industrytap.com/veinviewer-means-no-poking-people-relentlessly-locate-veins/27706. Retrieved 20 April 2022. 
  4. ↑ Buhr, Sarah (18 February 2015). "Scanadu’s New Pee Stick Puts The Medical Lab On Your Smartphone". Tech Crunch. Yahoo. https://techcrunch.com/2015/02/18/scanadus-new-pee-stick-puts-the-medical-lab-on-your-smartphone/. Retrieved 20 April 2022. 
  5. ↑ "About Us". Healthy.io. https://healthy.io/about-us. Retrieved 20 April 2022. 
  6. ↑ 6.0 6.1 Park, Richard (13 October 2014). "Examining the Physician Office Lab Market: Growth and Reimbursement". Medical Design Technology. Advantage Business Media. Archived from the original on 14 September 2015. https://web.archive.org/web/20150915023725/http://www.mdtmag.com/blog/2014/10/examining-physician-office-lab-market-growth-and-reimbursement. Retrieved 01 June 2015. 
  7. ↑ "How and Where IVD Will Find Growth in the Global POL Market – Part 2". Kalorama Information. November 2014. Archived from the original on 17 April 2015. https://web.archive.org/web/20150417204832/http://www.kaloramainformation.com/article/2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2. Retrieved 20 April 2022. 
  8. ↑ Park, Richard (29 September 2014). "Examining the Physician Office Lab Market: CLIA and Technology". Medical Design Technology. Advantage Business Media. Archived from the original on 15 September 2015. https://web.archive.org/web/20150915023715/http://www.mdtmag.com/blog/2014/09/examining-physician-office-lab-market-clia-and-technology. Retrieved 20 April 2022. 
  9. ↑ Health Industry Distributors Association (October 2020). "2020 U.S. Laboratory Market Report". Research and Markets. https://www.researchandmarkets.com/reports/5178165/2020-u-s-laboratory-market-report. Retrieved 20 April 2022. 
  10. ↑ 10.0 10.1 Thill, M. (October 2020). "Selling Moderate Complexity". Repertoire. https://repertoiremag.com/selling-moderate-complexity.html. Retrieved 18 April 2022. 
  11. ↑ 11.0 11.1 "Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration Staff" (PDF). U.S. Department of Health and Human Services. 12 March 2014. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070889.pdf. Retrieved 01 June 2015. 
  12. ↑ 12.0 12.1 12.2 Wirt, Tammy (24 March 2014). "NWS HHS FDA CRDH" (PDF). U.S. Food and Drug Administration. Archived from the original on 07 February 2019. https://web.archive.org/web/20190207182128/http://www.fda.gov/downloads/Training/CDRHLearn/UCM390761.pdf. Retrieved 27 May 2022. 
  13. ↑ "Fact Sheet: Medical Device User Fee Amendments of 2012". U.S. Food and Drug Administration. 3 August 2012. Archived from the original on 26 January 2015. https://web.archive.org/web/20150126091504/http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm313695.htm. Retrieved 27 May 2022. 
  14. ↑ Mullen, Allyson B. (19 March 2014). "FDA Issues Revised Final Guidance Regarding Administrative Procedures for CLIA Categorization". FDA Law Blog. Hyman, Phelps & McNamara, P.C. https://www.thefdalawblog.com/2014/03/fda-issues-revised-final-guidance-regarding-administrative-procedures-for-clia-categorization/. Retrieved 27 May 2022. 
  15. ↑ Rath, Prakash (5 March 2014). "Administrative Changes to FDA’s CLIA Categorization Program" (PDF). U.S. Food and Drug Administration. Archived from the original on 08 February 2017. https://web.archive.org/web/20170208064913/https://ftp.cdc.gov/pub/CLIAC_meeting_presentations/Pdf/Addenda/cliac0314/04_Rath_Admin%20Changes%20to%20FDA's%20CLIA%20Program.pdf. Retrieved 27 May 2022. 
  16. ↑ "CLIA Waiver by Application". U.S. Food and Drug Administration. 2 May 2022. https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application. Retrieved 27 May 2022. 
  17. ↑ "Quidel Receives Simultaneous FDA Clearance And CLIA Waiver For Its Sofia® Strep A+ Fluorescent Immunoassay (FIA) Via The FDA's New Dual Submission Program". Med Device Online. VertMarkets, Inc. 17 December 2014. https://www.meddeviceonline.com/doc/quidel-receives-simultaneous-fda-clearance-and-clia-waiver-0001. Retrieved 27 May 2022. 
  18. ↑ Mezher, M. (25 February 2020). "FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions". Regulatory Affairs Professionals Society. https://www.raps.org/news-and-articles/news-articles/2020/2/fda-finalizes-guidances-on-clia-waiver-application. Retrieved 20 April 2022. 
  19. ↑ "Recommendations for Dual 510(k) and CLIA Waiver by Application Studies". U.S. Food & Drug Administration. February 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-dual-510k-and-clia-waiver-application-studies. Retrieved 27 May 2022. 
  20. ↑ "Trinity Biotech Announces CLIA Waiver of Rapid Syphilis Test". GlobeNewswire, Inc. 16 December 2014. https://www.globenewswire.com/news-release/2014/12/16/691813/10112606/en/Trinity-Biotech-Announces-CLIA-Waiver-of-Rapid-Syphilis-Test.html. Retrieved 20 April 2022. 
  21. ↑ "HIV testing - prevalent CLIA waived tests". Percepta Associates, Inc. 12 March 2015. https://www.perceptaassociates.com/hiv-testing-clia-waived-tests/. Retrieved 20 April 2022. 
  22. ↑ 22.0 22.1 22.2 Johnson, Madeleine (26 April 2015). "Cepheid Sees 'Significant Opportunity' in Menu Expansion, CLIA Market". GenomeWeb. Genomeweb LLC. https://www.genomeweb.com/business-news/cepheid-sees-significant-opportunity-menu-expansion-clia-market. Retrieved 20 April 2022. 
  23. ↑ Johnson, Madeleine (19 June 2014). "With FDA-Cleared Flu Test, Alere Launches Isothermal MDx Platform for US Clinical Market". GenomeWeb. Genomeweb LLC. https://www.genomeweb.com/pcr/fda-cleared-flu-test-alere-launches-isothermal-mdx-platform-us-clinical-market. Retrieved 20 April 2022. 
  24. ↑ 24.0 24.1 Seiffert, Don (12 January 2015). "FDA waiver of Alere's flu test poses threat to market leader Cepheid". Boston Business Journal. American City Business Journals. https://www.bizjournals.com/boston/blog/bioflash/2015/01/fda-waiver-of-aleres-flu-test-poses-threat-to.html. Retrieved 20 April 2022. 
  25. ↑ Johnson, Madeleine (30 April 2015). "Q&A: BioMérieux's Christine Ginocchio Chats About Her Clinical Lab Career Arc, Syndromic PCR Panels". GenomeWeb. Genomeweb LLC. https://www.genomeweb.com/pcr/qa-biom-rieuxs-christine-ginocchio-chats-about-her-clinical-lab-career-arc-syndromic-pcr-panels. Retrieved 20 April 2022. 
  26. ↑ 26.0 26.1 Johnson, Madeleine (12 January 2015). "With CLIA Waiver and Widespread Flu, Alere Ramps Up Molecular Test Production". GenomeWeb. Genomeweb LLC. https://www.genomeweb.com/pcr/clia-waiver-and-widespread-flu-alere-ramps-molecular-test-production. Retrieved 20 April 2022. 
  27. ↑ Centers for Medicare and Medicaid Services, Division of Laboratory Services (May 2022). "Enrollment, CLIA exempt states, and certification of accreditation by organization" (PDF). http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf. Retrieved 17 May 2022. 
  28. ↑ "In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2". U.S. Food and Drug Administration. 18 April 2022. 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. Retrieved 20 April 2022. 
  29. ↑ Larkin, P.M.K.; Garner, O.B. (1 July 2020). "Molecular Point-of-Care Testing in Clinical Laboratories". Clinical Laboratory News. American Association for Clinical Chemistry. https://www.aacc.org/cln/articles/2020/july/molecular-point-of-care-testing-in-clinical-laboratories. Retrieved 20 April 2022. 
  30. ↑ Peck, A.D. (28 April 2021). "FDA Grants CLIA Waiver Allowing First Test for Chlamydia and Gonorrhea to Be Performed at the Point of Care". Dark Daily. https://www.darkdaily.com/2021/04/28/fda-grants-clia-waiver-allowing-first-test-for-chlamydia-and-gonorrhea-to-be-performed-at-the-point-of-care/. Retrieved 20 April 2022. 
  31. ↑ "AmericanBio expands product offerings, introduces exclusive CLIA Grade product line". AmericanBio, Inc. 17 October 2014. Archived from the original on 27 May 2015. https://web.archive.org/web/20150527162034/https://www.americanbio.com/news-events/americanbio-expands-product-offerings-introduces-exclusive-clia-grade-product-line1. Retrieved 20 April 2022. 
  32. ↑ "How to get a CLIA Waiver for your Medical Device: One and a Half Day In-person Seminar 2015 (Newark, NJ)". Research and Markets. May 2015. Archived from the original on 27 May 2015. https://web.archive.org/web/20150527174014/http://www.researchandmarkets.com/reports/3215400/how-to-get-a-clia-waiver-for-your-medical-device. Retrieved 20 April 2022. 
  33. ↑ [08 January 2020 ""CLIA Waivers: The What, The Why, and The How" Webinar"]. National Institutes of Health. 15 April 2015. Archived from the original on 27 May 2015. 08 January 2020. Retrieved 20 April 2022. 
  34. ↑ "FDA Clearance Consultants for 510(k) Submission". MRI Global. https://www.mriglobal.org/fda-clearance-consultants-for-510k-submission/. Retrieved 20 April 2022. 
  35. ↑ "Laboratories by Type of Facility" (PDF). Centers for Medicare and Medicaid Services. June 2011. Archived from the original on 10 April 2012. https://web.archive.org/web/20120410205217/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf. Retrieved 17 April 2022. 
  36. ↑ "Laboratories by Type of Facility" (PDF). Centers for Medicare and Medicaid Services. May 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf. Retrieved 17 May 2022. 
  37. ↑ 37.0 37.1 37.2 Bonislawski, A. (2 February 2022). "COVID-19 Accelerating Trend Toward Pharmacy-Based Testing". 360 Dx. https://www.360dx.com/clinical-lab-management/covid-19-accelerating-trend-toward-pharmacy-based-testing. Retrieved 27 May 2022. 
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