A draft guidance document recently submitted to the FDA, in which Roche, Gen-Probe, and Becton Dickinson suggests a new regulatory category of in vitro diagnostic tests, represents, at the least, a new approach by industry, said a former manager at the FDA.
“Although there has frequently been cooperation between FDA and industry on guidance, this is the first time anything like this has come out of the blue from industry,” said Harvey Rudolph, who left the FDA to work as global program manager for medical devices, Underwriters Laboratories.
Last week, BioArray News reported that Roche and two competitors had filed this suggested guidance document with the FDA, seeking to define the new category of in vitro analytical tests — and a new path for companies seeking regulatory approval to market these devices. The 19-page submission 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.”
“What you have is a traditional 510(k), minus a clinical trial and a claim for a normal range,” said Glen Freiberg, vice president of regulatory quality and government affairs at Gen-Probe, who joined regulatory executives from the other firms in drafting the draft guidance. “The forms are the same and the analytical claims are the same. It is just shortening the time to get something to market that is usable, and of value, without the clinical information.”
The companies’ draft guidance suggestion comes at a time when Roche has been summoned to a meeting with the FDA to discuss the propriety of marketing its AmpliChip-brand microarray product as an analyte specific reagent —essentially an ingredient that labs can use to conduct in vitro diagnostic tests. Following Roche’s introduction of its CYP450 AmpliChip with a press release on June 25, the FDA sent a letter to company officials requesting this meeting.
Although the AmpliChip remains on the market, this impending meeting has rendered hazy the chip’s future, as well as the future of other microarray based assays that companies are marketing as ASRs. Among these companies are Nanogen, which offers ASR products for use on its NanoChip platform, and HealthSpex, a Knoxville, Tenn.-based startup commercializing microarray-based technology from Oak Ridge Labs as ASRs.
Roche has a lot riding on the technology and its future clinical applications. The diagnostics giant has an 18-year technology licensing deal with Affymetrix that includes a $70 million one-time payment amortized over the next five years, as well as payments for chips, royalties, and milestone incentives for manufacturing AmpliChips.
In its AmpliChip rollout, Roche said it expects to generate annual revenues of $100 million a year by 2008. The company has said that it intends to seek FDA approval for the technology, but has not responded to BioArray News requests for comment or clarification about its role in the creation of the IVAT document, or its plans for its meeting with the FDA. Becton Dickinson also did not respond to requests for comment on the draft guidance.
While the draft document says nothing about the AmpliChip, the guidance suggestions may offer a regulatory pathway for microarray-based technology to enter the marketplace with FDA blessings. Or, without. That remains to be seen.
The suggested changes in the document, however, might present a format that would benefit Roche’s AmpliChip, if it is required to undergo a 510(k) approval process.
“The FDA is approaching microarrays as something that it may not be able to deal with as the manufacturers first thought,” Freiberg told BioArray News.
Freiberg said the draft document will be on the agenda for discussion at the FDA’s next roundtable meeting on Oct. 24.
“We will provide feedback from a broader audience, from industry people who were not part of the original group,” he said.
“There were several people that thought on this idea, but nobody executed,” said Freiberg. “I was in a conversation with Roche and BD, they mentioned their idea in ASRs and where they are going. We said: ‘Why don’t we, as a first step, create this new category of 510(k). It took a couple of months, but once the idea came about, we moved rapidly on it.”
For UL, Rudolph said that a microarray-based device would have to be approved by the FDA for the Accredited Persons Program first before before his company can conduct third-party review services.
“FDA has to make the decision first,” he said. “If they do, then we will make sure we have people who are competent. We are training our own folks.”