NEW YORK (GenomeWeb News) – Genentech last week filed a Citizen Petition with the US Food and Drug Administration urging the agency to take on greater oversight of diagnostic tests that are intended to guide therapeutic decisions and to regulate all laboratory-developed tests.
The biopharmaceutical firm has stepped into an issue that is on the minds of many molecular diagnostic manufacturers who are awaiting the FDA’s final guidance on In Vitro Diagnostic Multivariate Index Assays. The FDA issued a draft guidance on IVDMIAs in September 2006. The agency said at that time that such tests, ordinarily overseen by CLIA regulations, must instead be cleared by the agency due to their complexity.
Genentech said in its petition that while the FDA took a step in the direction of regulating all such tests, it would like the agency to expand and strengthen its regulatory oversight. “The failure to apply clear and consistent standards and regulatory oversight to all LDTs could threaten the public health and serve as a disincentive for the development of diagnostic test kits through FDA’s review pathway, thereby potentially undermining the move toward more personalized approaches to health care treatment and delivery,” the firm said.
According to Genentech, pharmacogenomic information is contained on the label of around 10 percent of all FDA-approved drugs. Included among those are Genentech’s trastuzumab (Herceptin), which requires that patients be tested for particular genetic characteristics and the results be considered before the drug is administered.
Danish diagnostics firm Dako makes the HercepTest, the first FDA-approved clinical test to determine HER2 protein overexpression in breast cancer tissues from patients for whom Herceptin treatment is being considered. But, Genentech pointed out, several other firms, including CombiMatrix Molecular Diagnostics and Monogram Biosciences are selling HER-2 LDTs that have not been approved by the FDA.
Genentech also lists a number of other firms, including Clinical Data, Rosetta Genomics, Response Genetics, and Genomic Health as firms selling laboratory-based tests that make claims that have not been verified by FDA. Meanwhile, it points to several instances where “FDA has shown a willingness to regulate some high risk LDTs based on concerns about patient safety.”
Among the examples it cited was FDA’s determination that LabCorp’s OvaSure test was misbranded and is “not within the scope of laboratory-developed tests over which the agency has traditionally exercised enforcement discretion.”
LabCorp subsequently decided to pull OvaSure from the market and seek a meeting with FDA officials to discuss its testing service and associated regulatory issues — Though the lab testing firm also made clear that it did not agree with the agency’s decision.
Genentech said “it is simply unknown whether [LDTs] are supported by sufficient analytical and clinical evidence.”
Early in 2008, several industry representatives and pharmacogenomics advocates blasted the IVDMIA guidance, calling it untenable, and potentially illegal. Presenters at that FDA meeting criticized that the document fails to clearly define what the FDA considers IVDMIAs; does not explain how the agency’s regulations would dovetail with CMS’ Clinical Laboratory Improvement Amendments guidelines; and would become a disincentive to innovation in personalized medicine.
While Genentech is arguing in favor of greater FDA oversight of LDTs, it noted that the Washington Legal Foundation filed a Citizen Petition in 2006 requesting that FDA not regulate LDTs as medical devices. The FDA hasn’t responded to that petition.