Roche and two competitors, Gen-Probe and Becton Dickinson, are asking the US Food and Drug Administration to consider a new category of in vitro diagnostic test — in vitro analytical tests — and a new path for companies seeking regulatory approval to market these devices, BioArray News has learned.
The three companies made the request in a 19-page submission to the FDA signed by Bradley Merrill Thompson, a partner of the Indiana-based law firm of Baker Daniels, on behalf of regulatory officials from Roche Diagnostics, Roche Molecular Diagnostics, BD, and Gen-Probe.
The three companies did not reply to requests for comment before deadline for publication.
The filing defines an IVAT as: “an in vitro diagnostic test for which analytical validity has been established.” It suggests that IVATs should be approved for marketing through an analytical 510(k) clearance “based on review of the same analytical data that FDA now examines in premarket notification submissions.”
The document, obtained by BioArray News, does not address microarray-based technologies specifically but does give examples where microarray-based technology is commonly used today in research laboratories — e.g. genetic tests measuring the presence or absence of an analyte such as a gene or a gene product. The document speaks of innovative technologies, and says that the authors will submit “technologies for which this proposed guidance would seem suitable” and would consult with other members of the IVD industry, trade associations, and members of the clinical industry and clinicians.
There is no mention made of Roche’s AmpliChip product.
However, the companies’ draft guidance suggestion comes at a time when Roche is facing an FDA-mandated meeting to discuss the propriety of marketing its AmpliChip-brand microarray product as an analyte specific reagent. Roche rolled out its CYP450 AmpliChip with a press release on June 25, which was then followed by a letter from the FDA requesting a meeting.
For Roche, the stakes are high. It has entered into an 18-year, $70 million collaboration with Affymetrix to produce the AmpliChip. Roche designs and markets the product, which Affymetrix manufactures. In introducing the product, Roche said that it expects revenues of $100 million within five years. If the FDA rules that the AmpliChip requires its premarket approval, rollout could be delayed by years, and potential benefits to patients delayed even more.
The FDA has regulated analyte specific reagents for use in in vitro diagnostic devices since 1998, but this case may represent a challenge of its ability to define and regulate ASRs that are microarray based. The agency has been candid in admitting a lack of expertise in how to regulate this, and other, early-stage genomic technologies. However, the agency is working to acquire knowledge through workshops and meetings with industry.
The document’s cover letter — dated June 17, 2003 — suggests that this submission was filed just days before Roche introduced its Ampli-Chip CYP450 microarray product.
The document is drafted in the form of an official agency guidance, down to the front-page inclusion of the e-mail address of Steven Gutman, the director of the agency’s Office of In Vitro Diagnostic Device Evaluation and Safety of the FDA’s Center for Devices and Radiological Health.
Gutman told BioArray News Monday that the agency has received the document and is reviewing it. He said he could not comment on the specifics of a document under review.
“We are working as proactively as we can to consider the regulatory options for helping expedite the transfer of technology to the marketplace, and we are working as proactively as we can to get products approved,” he said. “There is a clear end-point, but the journey there is quite colorful.”
Gutman said the document’s formatting in the form of an official guidance is not unusual. He said there is not standard-operating procedure for consideration of this suggestion by the FDA, and would not guess at any time frame for a decison.
“Our intent was to describe a process that would bring ‘innovative technologies’ to market,” the document’s cover letter to the FDA said. The suggested guidance should apply to innovative technologies as well as improvements on existing devices. And, the authors suggest, the agency should be flexible in the application of this process.
Manufacturers would have the option to pursue this analytical clearance, based on the establishment of analytical validity.
The FDA would have 60 days to make a determination on clearing the IVAT for marketing.
Recently, Henry Nordhoff, the chairman and CEO of San Diego-based Gen-Probe, which manufactured the first nucleic acid testing products approved by FDA in 1985, pointed to Roche and Becton Dickinson as its chief competitors in the DNA probe testing market.
In that context, the triumvirate involved in this suggested guidance is on the periphery of the microarray industry but clearly indicates the financial potential of a clinical marketplace where mass-produced, microarray-based diagnostic devices are in every doctor’s office and clinic, helping realize the far-off dream of personalized medicine.
The road there runs through the FDA offices in Rockville, Md.