The Diagnostics Pipeline: FDA Proceeds without Congress Over LDTs Reform
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
A year ago, Congress came close to passing legislation that would have finally imposed order over FDA regulation of laboratory-developed tests (LDTs).1 Although the Verifying Accurate Leading-edge IVCT Development (VALID) Act is back on the table and might pass this year, the FDA is not waiting for Congress to act.2 On July 26, the agency sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs (OIRA) for review.3 Although the proposal has yet to be made public, it may have significant ramifications for the future of LDTs in the US.
The Diagnostic Challenge
There were an estimated 3.3 billion in vitro diagnostic (IVD) tests, including both LDTs and FDA-cleared tests performed in the US in 2021, according to the Pew Charitable Trusts.4 The global market for LDTs has expanded significantly with an estimated 2022 value of US $10.04 billion, expected to reach $16.72 billion by 2030.5
The problem is that clinical utilization of LDTs is running far ahead of their regulation. The original Federal Food, Drug, and Cosmetic Act establishing the FDA’s authority to regulate drugs and medical devices does not address laboratory tests. The FDA has historically claimed that LDTs and IVD products are an extension of its jurisdiction over medical devices.6 But some argue that LDTs are actually “laboratory services” subject to Centers for Medicare & Medicaid Services (CMS) oversight under the Clinical Laboratory Improvement Amendments (CLIA).7
As neither of these theories has ever been tested in court, the FDA, with CMS’s consent, has exercised de facto oversight of LDTs. In so doing, the agency has created the rules via announcements and postings on its websites rather than following the proposed process that federal regulations require government agencies to use to gather public feedback when promulgating new regulatory requirements. As became clear during the early days of the pandemic, this lack of regulatory certainty has thwarted the innovation and development of LDTs, according to test developers.
The Twisted Road to LDT Reform
Many agree that the current LDTs regulatory system needs fixing, but reform has been a slow and unfruitful process. It began in 2014, when the FDA published draft guidance proposing to phase in a new risk-based regulatory system for LDTs.8,9 The laboratory industry criticized the plan for being overly onerous and the agency eventually withdrew the proposal in 2016.10
At that point, the impetus shifted to Congress, which proposed a series of LDT reform bills, none of which passed. The most recent proposal, the VALID Act, would create a comprehensive framework for FDA approval of LDTs and IVD tests based on the level of risk the product involves.11 See the G2 Intelligence July 2022 Laboratory Industry Report article, “Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage,” for more information.1
After last year’s narrow miss, many believe that VALID could pass this year.12 However, industry reaction to VALID has been mixed and it is unclear whether the currently constituted bill is the right solution.
FDA Seeks to Take Back Control Over LDTs Reform
After remaining on the sideline for nearly six years, the FDA has decided to take the initiative. On March 1, the FDA’s Elizabeth Hillebrenner, MSE, said that the agency considers the LDTs situation to be a serious public health problem. While the FDA would prefer to regulate LDTs under new legislation passed by Congress, Hillebrenner said that rather than waiting for a solution from government, the agency is “moving forward with rulemaking.” The remarks, reported by BioWorld, came during the American Clinical Laboratory Association’s annual meeting.13
It now appears as if the FDA was not bluffing, having sent an LDTs reform proposal to the OIRA. This is a procedural hurdle a federal agency must clear to publish a new rule in the Federal Register. The proposed notice indicates that the agency will unveil the new rule in August 2023, but that could be delayed if the OIRA does not approve the proposal immediately.14
What Happens Next
Though it won’t be clear what will happen until the FDA reveals the proposed rule, any attempt by the agency to implement LDTs regulation on its own without a clear legislative mandate from Congress could result in a legal challenge testing the agency’s authority to regulate LDTs and IVD tests. Such “ultra vires” lawsuits contending that government agencies have overstepped their bounds are common. Though not involving LDTs, in one recent case, three doctors sued the FDA, claiming that the agency’s statements on off-label use of the drug ivermectin impaired their ability to practice medicine.15 Of course, Congress could make this a moot point by adopting the VALID Act or alternative reform bill, which may be the very outcome the FDA is seeking in pushing its own regulatory proposal.
Bottom Line: It appears as if the LDTs situation may be finally heading to a resolution. However, it is impossible to predict what the conclusion will be and how long it will take to reach.
Here are the key new laboratory testing and diagnostics product clearances announced since mid-July 2023:
New FDA Approvals & Emergency Use Authorizations (EUAs)
|Becton Dickinson||510(k) clearance for BD Respiratory Viral Panel for BD MAX™ combination SARS-CoV-2, influenza A/B, and RSV molecular test|
|Becton Dickinson||Clearance for BD BBL™ Sensi-Disc™ Lefamulin 20 μg|
|Meridian Bioscience||Clearance for Premier® HpSA® FLEX™ assay for Helicobacter pylori in preserved and unpreserved stools|
|Numares Health||Clearance for AXINON® LDL-p Test System for measuring lipoproteins and identifying patients at risk for cardiovascular disease|
|Alphadera Labs||EUA for ALPHADx SARS-CoV-2 RT-PCR Test|
|Immunostics||EUA for Swab-N-Go Home Test COVID-19 Ag test|
|Siemens Healthineers||Breakthrough Device designation for Enhanced Liver Fibrosis (ELF™) Test to aid diagnosis of advanced fibrosis in patients with nonalcoholic fatty liver disease|
|Siemens Healthineers||Clearance for Atellica CI Analyzer|
|Gradientech||Breakthrough Device designation for QuickMIC® rapid antibiotic susceptibility testing system|
|Invivoscribe||Clearance for LeukoStrat® CDx FLT3 Mutation Assay for selecting patients with FLT3-ITD positive acute myeloid leukemia eligible for treatment with Daiichi Sankyo’s VANFLYTA® (quizartinib)|
|MeMed||Clearance for BV® test on whole blood samples for distinguishing between viral and bacterial cases|
|Lumos Diagnostics||510(k) clearance for FebriDx® for bacterial acute respiratory infections in patients in emergency or urgent care settings|
|Discover Labs||EUA for Discover Labs COVID-19 RT-PCR assay|
|Thermo Fisher Scientific||Clearance for iSensititre 20- to 24-Hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System|
|CAIRE Diagnostics||510(k) clearance for updated version of iFenom Pro portable instrument for detecting fractional exhaled nitric oxide in asthma patients’ breath|
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
New Approvals in Europe
|Palliare||Expanded approval of EVA15 insufflator and smoke evacuation system|
Other international clearances announced during the period:
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