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FDA Says CMDX Can Sell Its CGH Test Without Further Approval; Other Tests Will Face Scrutiny

CombiMatrix last week received a letter from the US Food and Drug Administration’s Office of In Vitro Diagnostics stating that the Constitutional Genetic Analysis Test sold through its CombiMatrix Molecular Diagnostics subsidiary will not require further evaluation from the agency in light of a draft guidance document on multivariate index assays FDA issued in September.
But, while CombiMatrix can now freely sell the CGAT, which uses array comparative genomic hybridization to test for a variety of genetic diseases, the company is not in the clear when it comes to the handful of tests it hopes to commercialize through CMDX over the next six months.
According to CombiMatrix, the FDA determined that its CGAT does not fall into a category known as an in vitro diagnostic multivariate index assay, and therefore does not require regulation as covered in the IVDMIA draft guidance, which was published on Sept. 7.
The IVDMIA draft guidance calls for FDA regulation for tests that use an algorithm to generate results from multiple data points, including protein and genetic data.
“We met with the FDA and they said our test does not meet their definition of an IVDMIA and thus does not require additional regulation, and we are able to run this test as a homebrew test and offer it to patients,” CombiMatrix CEO Amit Kumar told BioArray News this week.
Kumar added that the FDA’s decision only related to the CGAT, and that the company may still need to interact with the agency regarding other tests in its pipeline — including a suite of gene expression-based diagnostic assays for melanoma and bladder, kidney, and prostate cancer — to determine whether they qualify as IVDMIAs under the new guidance. All of the new tests are due to be released by June 2007.
“We hope [this FDA decision] is for all of our tests and that we will be able to launch them as homebrews without going through FDA approval, but I cannot say this is [the case] for all of our tests,” Kumar said.
He added that the letter provided some relief because the IVDMIA draft guidance had created “some uncertainty in the market” for companies developing homebrew tests. “I am aware of some companies that were going to get some venture capital funding, which has since slowed down because [these new regulations] have put some uncertainty into the sector,” Kumar said. “So it was very important for us to show the industry and the market that our test wasn’t going to be regulated.”
OIVD director Steve Gutman explained in an e-mail to BioArray News this week that the IVDMIA guidance “deals with software-derived and software-driven algorithms or formulas that lead to test scores, indices, or results that cannot be interpreted by the usual well-informed healthcare provider without help from the company.”
Gutman added that he did not believe that the new guidance would have a significant impact on array vendors that are planning to sell diagnostic assays. 
“I believe FDA regulatory questions are focused enough that this will have minimal impact on companies with well-developed products based on valid scientific evidence,” Gutman wrote. “FDA pre-market review for these should be a smaller hurdle in marketing of new diagnostics then user acceptance and uptake and obtaining third party payment,” he wrote. 
FDA is currently seeking public feedback on the guidance, which can be accessed here.
A Strategic Advantage?
Kumar said that the FDA’s decision to enable CombiMatrix to freely market the CGAT will give the firm a competitive advantage in the marketplace.
“We do not have the capital [our competitors] do. But the advantage we have is that we have the ability to bring our products to market as laboratory-developed tests without having to go through FDA approval,” he said. “That enables us to put these products on the market 18 to 20 months earlier than our competitors are able to do.”
Combi’s most direct competitors in the genetic testing space, like Signature Genomic Labs and Baylor College of Medicine, are similarly CLIA-approved, but currently only perform their tests within their own laboratories, whereas CMDX is looking to sell its tests to other diagnostic labs — a clear distinction.
CombiMatrix’s other competitors include companies that have received FDA clearance to sell arrays as IVDs, such as Affymetrix and Roche, as well as Osmetech, which received FDA clearance to sell its array-based cystic fibrosis carrier detection assay in January (see BAN 1/24/2006).

“FDA pre-market review for these should be a smaller hurdle in marketing of new diagnostics than user acceptance and uptake and obtaining third-party payment.”

Illumina has also signaled its intention to submit assays developed with partners like DeCode Genetics and ReaMetrix on its BeadXpress system for 510(k) approval in the future (see BAN 7/25/2006).
However, both Illumina and Affy have shown an interest in adopting the same homebrew model that CombiMatrix has followed. For example, in July, Illumina CEO Jay Flatley said that in addition to seeking 510(k) clearance for future BeadXpress assays, the company also intends to sell the BeadXpress system to CLIA-approved labs where users can build and administer their own homebrew tests.
In September, Affymetrix announced a partnership with Partners Healthcare to develop tests on Affy’s GeneChip platform that will later be offered to Partners patients in its CLIA-approved laboratories (see BAN 9/7/2006). The company has also pledged to develop and introduce new tests through Affymetrix Clinical Laboratories. While its clinical labs were supposed to open by the second half of the year, Affymetrix has not yet publicly announced its status (see BAN 8/1/2006).  
Still, both Illumina and Affymetrix have stated that any diagnostic homebrews developed on their respective platforms are at least a year away — a time lapse that CombiMatrix hopes will play to its advantage.

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