Laboratory developed test
Laboratory developed test (LDT) is a term used to refer to a certain class of in vitro diagnostics (IVDs) that, in the U.S., were traditionally regulated under the Clinical Laboratory Improvement Amendments program.{{cite web|title=CLIA Overview|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/|publisher=CMS|language=en-us|date=11 April 2018}}
Laboratory-developed tests (LDTs) are a class of in vitro diagnostics (IVDs) designed, manufactured, and used within a single laboratory. They are employed for various medical diagnoses and research applications, offering advantages in flexibility and fostering innovation in the diagnostics field.{{Cite web |date=2024-05-23 |title=Laboratory Developed Testing Market to Reach $4582.6 Million |url=https://www.pmrinsights.com/2024/05/23/laboratory-developed-testing-market/ |access-date=2024-05-23 |language=en-US}}
United States
In the United States, the Food and Drug Administration (FDA) has determined that while such tests qualify as medical devices, these products could enter the market without prior approval from the agency. In 2014, the FDA announced that it would start regulating some LDTs.{{cite news|title=Laboratory Developed Tests|url=https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/LaboratoryDevelopedTests/default.htm|archive-url=https://web.archive.org/web/20170114055343/http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/LaboratoryDevelopedTests/default.htm|url-status=dead|archive-date=January 14, 2017|work=FDA|date=26 March 2018|language=en}} In general, however, it has not done so, as of April 2019.{{cite web |title=Oversight Of Laboratory-Developed Tests |url=https://documents.cap.org/documents/general-ldt-faqs.pdf |website=CAP FAQs, Topic: Laboratory-Developed Tests |publisher=College of American Pathologists |access-date=15 December 2022 |archive-url=https://web.archive.org/web/20190521191008/https://documents.cap.org/documents/general-ldt-faqs.pdf |archive-date=21 May 2019 |date=2 April 2019}}
As LDTs do not require FDA 510(k) clearance required by other diagnostic tests, they have been viewed as a regulatory loophole by opponents.{{cite journal|last1=Jotwani|first1=Rohan|last2=Boumil|first2=Marcia|last3=Salem|first3=Deeb|last4=Wetterhahn|first4=Madeline|last5=Beninger|first5=Paul|title=Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion|journal=Clinical Pharmacology in Drug Development|date=September 2017|volume=6|issue=5|pages=433–438|doi=10.1002/cpdd.374|doi-access=free}}{{cite news|last1=Duhaime-Ross|first1=Arielle|title=FDA wants to close the loophole that Theranos used, but Republicans don’t understand why|url=https://www.theverge.com/2015/11/17/9750048/ldt-loophole-fda-hearing-theranos-lab-tests|accessdate=5 April 2018|work=The Verge|date=Nov 17, 2015}}
= Direct-to-consumer =
Direct-to-consumer tests are regulated as medical devices, although they are not necessarily reviewed by the FDA.{{Cite web|url=https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm624726.htm|archive-url=https://web.archive.org/web/20181206212657/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm624726.htm|url-status=dead|archive-date=December 6, 2018|title=In Vitro Diagnostics - Direct-to-Consumer Tests|last=Health|first=Center for Devices and Radiological|website=www.fda.gov|language=en|access-date=2018-12-02}}
23andMe direct-to-consumer genetic tests were originally offered as LDTs, but the FDA challenged that and forced the company to submit the test for approval as a class II medical device.{{Cite web|url=https://www.lexology.com/library/detail.aspx?g=dcefa424-931f-4125-8c27-fcf5cf721396|title=FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics {{!}} Lexology|last=Yarbrough|first=Knobbe Martens-Daniel K.|last2=Fuller|first2=Michael|language=en|access-date=2018-12-02}}{{Cite news|url=https://www.mddionline.com/23andme-warning-letter-climaxes-7-year-dilemma-over-lab-developed-tests|title=23andMe Warning Letter Climaxes 7-Year Dilemma Over Lab-Developed Tests|date=2014-01-14|work=MDDI Online|access-date=2018-12-02|language=en}}
Companies
Several companies offer lab-developed tests.{{Cite news|url=https://www.nytimes.com/2014/08/01/business/fda-to-regulate-lab-developed-test-kits.html|title=F.D.A. Acts on Lab Tests Developed In-House|last=Pollack|first=Andrew|date=2014-07-31|work=The New York Times|access-date=2019-05-22|language=en-US|issn=0362-4331}}
Several prominent companies are at the forefront of developing innovative Laboratory Developed Tests solutions, including Adaptive Biotechnologies Corporation, Quest Diagnostics, Roche, and Illumina
Market Overview
The global market for laboratory-developed testing (LDT) is experiencing significant growth, with a projected value of US$ 4582.6 million by 2030 from US$ 3518.7 million in 2023 (CAGR of 3.8%) This growth is driven by advancements in genetic testing, the increasing demand for personalized medicine, and the ongoing expansion of the healthcare and diagnostics sectors