FDA Watch: Doubling of User Fees, LDT Maneuvering & Potential OK for First Diabetes POC Dx Test

Trump Proposes Doubling FDA User Fees
The Trump 2018 budget proposal would double user fees that pharma and medical device companies pay the FDA to review their products from $1 to $2 billion. "Industries that benefit from FDA approval can and should pay for their share," according to the proposal. While the reasoning may be sound, a 100 percent increase in user fees would inflict disproportionate financial harm on biotech and other smaller, entrepreneurial firms operating on tight margins. In addition to gutting the revenue targets that the FDA painstaking negotiated with industry, the proposal would turn the understanding that user fees are a supplementary rather than primary source of FDA review activities upside down.

Maneuvering on LDTs
The laboratory-developed tests (LDT) cauldron continues to bubble. Two weeks after the FDA issued a discussion paper outlining a new approach to oversight of LDTs (See LIR, January 2017), a group of 33 health care organizations including the American Cancer Society, asked Congressional leaders to push the process.

Meanwhile, a revised plan to regulate LDTs has surfaced in the US House of Representatives. The discussion draft of the Diagnostic Accuracy and Innovation Act, which was introduced as an alternative to the FDA LDTs plan, proposes creation of a new regulatory category for in vitro clinical tests (IVCTs) distinct from medical devices. Regulatory authority over IVCTs would be shared with the FDA overseeing test development and validation, CMS overseeing traditional lab activities necessary to perform testing, and states maintaining oversight of test results interpretation.

FDA Mulls First POC Dx Test for Diabetes
Health professionals currently rely on point-of-care (POC) tests measuring HbA1c to monitor and manage glycemic control in diabetes patients. But the time needed to meet proficiency standards impairs the tests’ diagnostic value. Now the FDA is considering what would be the first approved POC HbA1c diagnostic test for diabetes in the US. Alere’s Afinion HbA1c Dx would be considered a moderate-complexity test, i.e., labs would have to perform proficiency testing and follow other quality controls. But Alere also makes a CLIA-waived version of Afinion for monitoring HbA1c that’s subject to less scrutiny which some experts believe can be used not just to monitor glycemic control but actually detect diabetes earlier in the process.

The Pipeline
On Feb. 2, Abbott Laboratories announced that its RealTime Zika assay had received expanded FDA Emergency Use Authorization (EUA) to include use on whole blood samples. The original EUA was limited to use on human serum, EDTA plasma and urine samples.

In addition to the expansion of the Abbott RealTime Zika EUA discussed above, at least 10 diagnostics products have received FDA clearance in February and March, including:

Manufacturer(s) Product(s)
Myriad Genetics Approval of BRACAnalysis CDx as a complementary diagnostic to identify ovarian cancer patients with germline BRCA mutations likely to benefit from treatment with Zejula (niraparib)
Beckman Coulter Diagnostics DxC 700 AU chemistry analyzer
Philips ElastQ Imaging, noninvasive test of liver tissue stiffness
Accelerate Diagnostics Inc. Marketing of PhenoTest BC Kit, which identifies organisms causing bloodstream infections and antibiotics to which the organism is likely to respond
BioMérieux Inc. Expanded use of Vidas Brahms PCT Assay to decide whether to start antibiotic treatment of lower respiratory tract infections or stop such treatment of sepsis
Immunexpress Approval of Septicyte Lab, RNA-based blood test to determine a patient’s systemic inflammation was caused by infection
DiaSorin Approval to market its Simplex C. difficile Direct Assay in US
Hologic Pre-market approval of Aptima HCV Quant Dx assay on Panther system for hepatitis C viral load monitoring and confirmation of HIV diagnosis in US (not approved for sale in US)
Cepheid Approval of Xpert Xpress Flu and Xpert Xpress Flu/RSV tests, first in Cepheid’s planned line of 30 minute (or less) Xpress branded tests

Great Basin Scientific also announced that it has submitted a new FDA Section 510(k) application for its Bordetella Direct Test, a sample-to-result PCRbased assay that detects the infectious agent that causes whooping cough (Bordetella pertussis) directly from a nasopharyngeal swab.

New CE Marks
Diagnostic products receiving CE marking for Europe in February and March include:

Manufacturer(s) Product(s)
Roche Cobas HPV assay on the Cobas 6800/8800 systems for cervical cancer screening
HTG Molecular Diagnostics HTG EdgeSeq ALKPlus assay EU for analyzing mRNA ALK gene rearrangements in lung tumor specimens
Nucleix Bladder EpiCheck test for monitoring bladder cancer patients
DiaCarta ColoScape, a PCR-based kit that detects mutations associated with colorectal cancer
Medical Innovation Ventures (aka Mediven) PCR kit to detect different serovars of leptospira (i.e., the bacteria that causes leptospirosis)
Pressure BioSciences Barocycler 2320Extreme instrument, a sample preparation machine for proteomic analysis
Agilent Technologies Expansion of use for its Dako PD-L1 IHC 22C3 pharmDx, a companion diagnostic for Merck’s Keytruda, in Europe

In addition, Illumina announced that an expanded version of its VeriSeq NIPT software for analyzing fetal aneuploidies has met EU’s in vitro diagnostic directive requirements and that it will apply the CE mark to the software. Genedrive reported that it’s seeking CE marking for its hepatitis C test, the Genedrive HCV ID Kit.

Outside North America
Roche Diagnostic Canada said that it has secured the approval of Health Canada for its Cobas EGFR Mutation Test v2 for marketing in that country.

And Chinese firm Amoy Diagnostics announced that it is seeking approval from Japan’s Pharmaceuticals and Medical Devices Agency for its OncoGuide AmoyDx ROS1 fusion kit for identifying advanced non-small cell lung cancer patients with ROS1 gene fusions.


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