FDA Watch: Discussion Paper Signals New Approach (Not Retreat) to LDT Regulation

After nearly two years of inactivity, things are suddenly heating up on FDA regulation of laboratory developed tests (LDTs). As promised, the agency took action on LDTs by the end of 2016—but not in the way everybody expected. Instead of finalizing the controversial rule it proposed in October 2014, the agency announced that it was putting LDT regulation on ice pending discussions with the new Congress and administration.

Some may have interpreted the November announcement as signalling the FDA’s intention to withdraw from LDT regulation altogether. But on Jan. 13, the agency dashed those hopes by issuing a discussion paper that reaffirms its intention to regulate LDTs. The silver lining is that the agency seems to have softened its approach.

The FDA’s New Thinking on LDTs
The discussion paper summarizes the feedback it received on the 2014 proposed rule. But its real significance is the discussion of how the FDA’s own thinking on LDT regulation has evolved since 2014. Over the two years of "engagement," "positions of many groups, including the FDA, have evolved," the paper notes. It then alludes to an alternative model and outlines the key features it may incorporate, including:

  • Phased in oversight program over four years rather than the originally proposed nine years;
  • Grandfathering for many LDTs already on the market;
  • Broader definition of LDTs for unmet needs;
  • Collaboration between FDA and third parties to use existing review standards and certification programs—such as the National Glycohemoglobin Standardization Program or the Cholesterol Reference Method Laboratory Network—for evidence standards;
  • Potential leveraging of existing review programs for third-party review such as New York State’s Clinical Laboratory Evaluation Program and independent CLIA accreditation programs;
  • Clinical collaboration with stakeholders and health care professional organizations on standards for analytical and clinical validity;
  • Public availability of evidence of analytical and clinical validity;
  • Reliance on CLIA certification requirements plus three FDA quality systems requirements regarding test development processes—design controls, acceptance activities, and procedures for corrective and preventive action (CAPA); and
  • Postmarket surveillance requiring labs to report serious adverse events for texts except for traditional LDTs, LDTs for public health surveillance, specific transplantation related LDTs, and forensic-use LDTs.

New FDA Approvals
In other FDA news, at least four diagnostics products received clearance from the FDA in January so far, including:

Manufacturer(s) Product(s)
Arterys Arterys Cardio DL software providing automated ventricle segmentation from conventional heart MRI scans (which also received CE clearance in December)
Luminex Aries Group B Streptococcus (GBS) assay for antepartum detection of GBS colonization in pregnant women from Lim broth enriched vaginal-rectal swab specimens
Hologic Pre-market approval of Aptima HIV-1 Quant test for HIV viral load monitoring in the US (also CE-IVD approved for both monitoring and diagnosis outside the US)
IncellDx IVD Class I status approval of IncellPrep single-cell preparation kit for solid tissues (which also received CE-IVD approval in Europe)

New FDA Applications
Companies that submitted new FDA applications during the month include:

  • QIAGEN for pre-market approval of QuantiFERON®-TB Gold Plus, the fourth generation of its tuberculosis infection blood test;
  • HTG Molecular Diagnostics for pre-market approval of HTG EdgeSeq ALK Plus Assay used as a companion diagnostic for crizotinib;
  • Curetis for its Unyvero system and Unyvero lower respiratory tract panel molecular test platform and cartridge, respectively;
  • Great Basin Scientific for its molecular panel assay for stool pathogens.

New CE Marks
Hologic’s Aptima HIV-1 Quant test for HIV viral load monitoring that received FDA pre-market approval for monitoring in the US also received CEIVD marking for both monitoring and diagnosis in Europe this month. Other products to receive CE marking for Europe in January:

Manufacturer(s) Product(s)
GenePOC Revogene instrument and tests for GBS and Clostridium difficile
Sophia Genetics CE-IVD certification of Hereditary Cancer Solution for examining 27 genes associated with hereditary breast, ovarian and gastrointestinal cancers
Volition Rx NuQ Colorectal Cancer Screening Triage Test (blood-based test)
IncellDx IVD Class I status approval of IncellPrep single-cell preparation kit for solid tissues (which also received FDA IVD Class I status approval)

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