FDA Watch

FDA Watch: VALID and VITAL Bills for LDTs Regulation Are Back in Play

Reform of FDA Laboratory Developed Tests (LDTs) regulation is back on the agenda and this time it may result in actual legislation. Fired by the agency’s ineffectiveness in bringing new SARS-CoV-2 tests to market rapidly during the early days of the public health emergency, Congress exhumed the VALID and VITAL Acts proposing different approaches to LDTs regulation.

The FDA’s Current Regulatory “System”

Since the original Food Drug & Cosmetics Act legislation doesn’t provide for regulation of laboratory tests, the FDA justifies its regulatory authority over LDTs, aka, in vitro clinical tests (IVCTs), as an extension of its power to regulate medical devices. Accordingly, it clears LDTs via the 510(k) premarket review pathway. Rather than following the notice of rulemaking process designed to ensure transparency and public input into new federal regulation, the agency regulates LDTs via informal guidance that it posts on its website. Adding to the arbitrariness is the “enforcement discretion” the agency exercises by deferring regulation of most LDTs to the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) law.

Fixing this mess has been an almost decade-long endeavor. On the legislative front, a bill called the Diagnostic Accuracy and Innovation Act (DAIA) would have removed diagnostic tests from the definition of a medical device and thus placed it outside the scope of the 510(k) pathway. Rather than totally stripping the FDA of regulatory authority over IVCTs, a 2018 bill called the Verifying Accurate, Leading-edge IVCT Development (VALID) proposed to limit it by establishing IVCTs as a new product category consisting of LDTs and test kits. The bill didn’t get far; nor did an updated version of it proposed in March 2020.

The VALID Act of 2021

The VALID Act of 2021 would create a risk-based framework for IVCT regulation:

High-Risk Tests: High-risk tests, like novel assays, would have to go through premarket review to verify analytical and clinical validity.

Lower-Risk Tests: VALID would establish a separate technological certification program for lower-risk tests, as well as a new system allowing hospitals and labs to submit their tests electronically.

Emergency Use Tests: To eliminate the EUA bottlenecks and delays that became apparent during the pandemic, validated tests would be authorized to use for emergency purposes pending review of their EUA clearance.

Grandfathered Tests: Qualifying LDTs offered for clinical use before enactment of the legislation would receive “grandfathered” status and not require premarket review, provided that they carry a disclaimer on the label and are neither modified nor flagged by the FDA as posing a special concern.

Transitional Tests: IVCTs first offered between the date VALID is enacted and 90 days after it takes effect would be allowed to remain on the market as “transitional” IVCTs, provided that the test maker submits a timely marketing application to the FDA.

Other key features of the 2021 version of VALID:

  • Establishment of test design and quality requirements for IVCTs, equivalent to the current Quality Systems requirements for medical devices;
  • Creation of a new process that the FDA can use to request information from an otherwise exempt IVCT, such as a transitional or grandfathered test, in certain situations;
  • Authority of FDA to participate in collaborative communities for purposes of “facilitating community solutions and decision-making” for IVCTs;
  • A requirement that FDA create and maintain an IVCTs database that is more extensive than the current device registration and listing database; and
  • New IVCT adulteration, misbranding and postmarket surveillance requirements mirroring current rules that apply to medical devices.

The VITAL Act

VALID isn’t the only LDTs regulation bill on the table. First introduced by Senator Rand Paul (R-KY) in March 2020, the newly reintroduced Verified Innovative Testing in American Laboratories Act (VITAL) would transfer the FDA’s regulatory powers over LDTs to the U.S. Department of Health and Human Services (HHS). Supporters of the bill believe that the FDA’s slow response in expanding access to SARS-CoV-2 virus tests during the pandemic reaffirms the need for stripping the agency of power to regulate LDTs. “When we face a health emergency, government should trust academic, community and public health labs to do what they are already trained and certified to do,” noted Senator Paul in a press release. “With all of the debates about how government should respond, here’s one thing it can stop doing: piling counter-productive bureaucratic hurdles in the way of our medical professionals.”

Subsequent FDA management of the EUA process seemed to vindicate and strengthen the drive to get the agency out of the business of regulating LDTs. In August 2020, HHS issued a determination stating that the FDA can’t require premarket review of LDTs without notice and comment rulemaking. While not eliminating FDA regulatory authority over LDTs, the HHS determination barred the agency from its traditional—and to most in the industry—infuriating practice of exercising that authority via website guidelines and other informal pronouncements serving as shortcuts around the burdensome notice and comment rulemaking protocols.

Here are some of the key new FDA EUAs and clearances announced in July 2021:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Promega Clearance to use OncoMate MSI Dx Analysis System to screen colorectal cancer patients for Lynch syndrome
Ortho-Clinical Diagnostics EUA for Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
Becton Dickinson EUA for sodium citrate collection tubes
AnchorDx Breakthrough device designation for UriFind urine DNA methylation early bladder cancer detection test
First Light Diagnostics Marketing clearance for SensiTox C. difficile Toxin Test
First Light Diagnostics Marketing clearance for MultiPath Analyzer
GenBody EUA for COVID-19 Ag point-of-care antigen test
Ortho-Clinical Diagnostics EUA for Vitros Anti-SARS-CoV-2 IgG Quantitative test
Thermo Fisher Scientific EUA for TaqPath COVID-19 RNase P Combo Kit 2.0
Ellume EUA for COVID Antigen Test by CLIA labs
Exact Sciences EUA for COVID-Flu Multiplex Assay
BioGx EUA for Xfree COVID-19 Direct RT-PCR assay
Bio-Rad EUA for BioPlex 2200 SARS-CoV-2 IgG assay
Foundation Medicine Clearance for tissue-based FoundationOne Liquid CDx as companion diagnostic to identify patients eligible for treatment with capmatinib (Novartis’ Tabrecta)
Foundation Medicine Clearance for FoundationOne CDx test as companion diagnostic for Takeda’s FDA-approved non-small cell lung cancer treatment brigatinib (Alunbrig)
Access Bio EUA for CareStart EZ COVID-19 IgM/IgG, point-of-care version of firm’s SARS-CoV-2 antibody assay
Inova Diagnostics 510(k) clearance for Aptiva System
Inova Diagnostics 510(k) clearance for Aptiva Celiac Disease IgA Assay

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Manufacturer(s) Product(s)
Scope Fluidics Fully automated PCR One SARS-CoV-2 panel
MeMed MeMed COVID-19 Severity COVID-19 management tool
PathogenDx DetectX-Rv assay for COVID-19
Agilent Technologies Expanded use of PD-L1 IHC 22C3 pharmDx as companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with cemiplimab (Regeneron Pharmaceuticals and Sanofi’s Libtayo)
Hologic Use of Aptima SARS-CoV-2 molecular assay on saliva samples
Bio-Rad Laboratories Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit
Genetron Health One-Step Seq eight-gene lung cancer sequencing assay
BioLytical Laboratories Insti HCV Antibody Test
Quidel Respiratory viral panel test for use with Savanna multiplex molecular analyzer
QuantumDx Rapid PCR, point-of-care diagnostic system along with assay to detect SARS-CoV-2
Qiagen NeuMoDx HAdV Quant Assay for identification and quantification of human adenovirus DNA
Genome Diagnostics NGSgo-MX11-3 human leukocyte antigen typing product for organ and stem cell transplantation testing
LumiraDx SARS-CoV-2 RNA STAR Complete assay
Attana Attana Cell 250 analyzer instrument

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Cue Health India Cue COVID-19 Test Kit
Amoy Diagnostics
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Precision Medicine Asia
Japan AmoyDx Pan Lung Cancer PCR Panel
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