FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry

The lab industry played an active role in the drafting of the Diagnostic Accuracy and Innovation Act (DAIA), a bill designed to establish a new regulatory regime for laboratory developed tests (LDTs). But last month, without consulting anybody, the FDA sent a Technical Assistance document (TA) proposing a DAIA re-write in the interest of “public health.”

FDA’s 5 Proposed DAIA Changes

Among the notable differences between the current DAIA and the FDA’s new TA proposal:

1. Definition of IVCTs
The DAIA defines in vitro clinical tests as a laboratory test protocol or finished product, which is used in disease detection, screening, prediction, and monitoring, and for selecting treatment based on analysis of human samples. The TA definition includes test platforms and software used for these same purposes as IVCTs and doesn’t specifically mention “finished product,” “laboratory test protocol” or “laboratory-developed test.”

2. Risk Categories
The DAIA establishes a process for determining whether a test is low-risk, moderate-risk or high risk, and outlines regulatory requirements consistent with a test’s risk level.  The TA defines high and low risk tests but leaves out moderate-risk. 

3. Timelines
The DAIA contains strict review timelines that FDA must meet to avoid having the test automatically approved. The TA contains no timelines for review.

4. Regulation of IVCTs
The DAIA would create a new center for IVCTs within the FDA. The TA proposes creation of collaborative communities of private and public stakeholders who advise the FDA on mitigating measures and performance standards for IVCTs.

5. Raw Data
The TA makes explicit that raw data should be submitted for high-risk, cross-referenced, or first-of-a-kind tests, and that the Department of Health and Human Services secretary can request raw data for any other test.

New FDA Approvals

Here’s a look at some of the key FDA approvals announced at the end of August through the third week of September:

Manufacturer(s) Product(s)
Roche Approval of Cobas EGFR Mutation Test v2 as companion diagnostic test with AstraZeneca’s cancer drug Iressa (gefitinib) for non-small cell lung cancer patients
Cepheid 510(k) clearance for Xpert Xpress Flu Assay on new software version of GeneXpert Instrument System
Thermo Fisher Scientific Clearance for addition of Plazomicin at concentrations 0.06 to 128 µg/mL to Sensititre 18-24 MIC for susceptibility testing of non-fastidious gram-negative organisms
InBios International 510(k) clearance for DENV Detect NS1 ELISA, an antigen detection assay providing presumptive dengue virus diagnosis before IgM antibodies are present
DiaSorin Molecular 510(k) clearance for Simplex Bordetella Direct real-time PCR assay system for direct amplification, detection and differentiation of Bordetella pertussis and Bordetella parapertussis DNA from unprocessed nasopharyngeal swabs
Microbiologics Clearance for BD Max CT/GC/TV 20-Day QC Panel to monitor in vitro laboratory nucleic acid testing procedures for qualitative detection of Chlamydia trachomatisNeisseria gonorrhoeae, and Trichomonas vaginalis in genitourinary specimens
Assure Tech Clearance for AssureTech Panel Dip Tests and AssureTech Quick Cup Tests urine drug tests for qualitative and simultaneous detection of amphetamine, oxazepam, cocaine, marijuana methamphetamine, morphine, oxycodone, secobarbital, buprenorphine, methylenedioxy-methamphetamine, phencyclidine, methadone, EDDP, nortriptyline and d-propoxyphene
Biokit Clearance for Advia Centaur Herpes-2 IgG assay for qualitative determination of IgG antibodies to herpes simplex virus type 2 in human serum and plasma
Quidel Clearance and CLIA waiver for Sofia 2 Lyme FIA assay to detect antibodies to the bacterial pathogen that causes Lyme disease

New CE Marks & Global Certifications

Notable European CE certifications:

Manufacturer(s) Product(s)
Cepheid CE-IVD marking for Xpert HCV VL Fingerstick for detecting RNA levels of HCV directly from blood
CE marking for Liaison QuantiFeron-TB Plus workflow
Optrascan CE-IVD marking for firm’s on-demand desktop scanning systems
Asuragen CE marking for QuantideX, a new NGS oncology panel

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Beckman Coulter Canada Health Canada Medical Device License approval for DxH 900 Hematology Analyzer and its Early Sepsis Indicator
Illumina China China National Drug Administration regulatory clearance for MiSeqDx system

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