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Will Array-Based Molecular Dx Shops Meet Their Goal of Winning FDA Gold in 2006?


It was one year ago that Roche Molecular Diagnostics and Affymetrix opened new doors for the microarray industry by receiving clearance from the US Food and Drug Administration to sell their CYP450 AmpliChip (see BAN 1/5/2005).

At the time, the FDA said the clearance would "pave the way for similar microarray-based diagnostics to be developed in the future." But other than the long-awaited release of an FDA guidance document for submitting pharmacogenomic data in March, and the clearance of an assay on BioArray Solutions' BeadChip Test System, 2005 was a year in which many array companies with in vitro diagnostics in the pipeline had one thought on their mind: "2006" (see BAN 6/22/2005).

To be sure, "in the future" could mean many things, and AmpliChip's pioneering steps do not guarantee that other array platforms will be cleared any time soon, if at all.

At least seven shops with array-based tests in development speculated over the course of 2005 that 2006 would be the year that their respective platforms receive FDA approval. But now that '06 is upon them, the best many can now offer on the fate of their tests is a cautious "maybe."

However, while they may have been more vocal during 2005, these firms' more recent reticence does not necessarily reflect on their abilities to meet their goals.

"I am not good at predicting the future. We [at the FDA] hope to see more cutting-edge molecular diagnostics in 2006, but I cannot quantitate that."

GE Healthcare was among the first companies to disclose last year that it was considering submitting for regulatory approval its CodeLink P450 SNP array. At the time, the company predicted it would file the platform with European regulators by the end of 2005. An exact date for submitting to the FDA was never disclosed.

"We are going into the diagnostics market," CodeLink field specialist Brad Cooney told attendees at the World Microarray Congress in Vancouver in March. "We are just going through the FDA trials, and we hope by the end of the year 2005 to have our CE [Mark] in Europe" (see BAN 3/23/2005).

However, according to a spokesperson for GE, as of the last days of 2005 the P450 test has been submitted neither to European nor US regulators. The spokesperson declined to be more specific, though she told BioArray News last month that GE "continues to be committed to our vision of personalized healthcare and the development of our molecular diagnostics products is integral to the execution of this vision."

Similarly quiet these days are Spectral Genomics and Vysis, both of which pledged last spring to have FDA-cleared platforms for chromosomal microarray analysis on the market in 2006. Yet in separate e-mails to BioArray News last month, both companies declined to speculate on whether they would make good on those predictions.

In Spectral's case, former CEO Ed Chait told BioArray News in May 2005 that his company's Constitution Chip, which tests for 42 different genetic diseases, could receive FDA clearance as soon as June 2006.

"I think we will get some clearance by mid-2006, for certain diseases anyway," Chait said at the time. But Robert Johnson, who replaced Chait as CEO in August 2005, declined to discuss the company's interactions with the FDA in an e-mail last month. Chait is now serving Bioanalytical Systems as vice president and chief scientific officer.

In the case of Vysis, Kathryn Becker, the firm's microarray and instrumentation product manager, told BioArray News in May 2005 that Vysis expected its GeneTrait CGH array-based diagnostic — a test for common chromosome abnormalities observed in children with developmental delay, mental retardation, and physical birth defects — would be approved in 2006 (see BAN 5/11/2005). But two weeks ago a spokesperson for Vysis parent Abbott Molecular said the test will be used in clinical trials early this year, but declined to offer a specific timeframe for when GeneTrait could receive FDA clearance.

Nanogen is another company that last year promised regulatory momentum in 2006, only to fall silent in the last days of 2005. Last month a Nanogen spokesperson declined to speculate on when the company may submit its NanoChip 400 System for clearance even though president and chief financial officer David Ludwigson told investors during a conference call in November 2005 that "during the course of 2006 [Nanogen] plans to submit the 400 System with one or more assays to the FDA for clearance" (see BAN 11/9/2005).

Look Who's (Somewhat) Talking

Not all array companies that made regulatory promises in 2005 are in quiet mode. Bruce Huebner, president of Pasadena, Calif.-based Osmetech Molecular Diagnostics, told BioArray News in November that the company expected the agency to clear its cystic fibrosis assay on Osmetech's eSensor Detection System in the first quarter of 2006 (see BAN 11/30/2005). Last month, he said Osmetech is still "in a holding pattern" with the FDA as the agency continues to review its application, which was submitted last May.

Glenda Anderson, president and CEO of PathWork Informatics, told BioArray News in November 2005 that the company expected its PathChip to be cleared by the FDA in 2006. Anderson said said in an interview last month that the company's PathChip, which is manufactured by Affymetrix and runs on the Affy platform, may be among the first array-based IVDs cleared for marketing this year (see BAN 11/16/2005).

"We do have indications that we are likely to be one of the first submissions in 2006. Timing will hinge on an agreement that we reach with" the FDA, Anderson said.

The FDA could not be reached to comment on Anderson's statement by press time.

FDA Prepares for Busy Year

According to Steven Gutman, director of the FDA's Office of In Vitro Diagnostic Device and Safety Evaluation, the agency could receive more submissions this year than it did last year. However, he was hesitant to "predict the future."

"I am not good at predicting the future," Gutman told BioArray News last week. We hope to see more cutting-edge molecular diagnostics in 2006, but I cannot quantitate that," Gutman said.

To handle the possibility of multiple submissions, the FDA has hired "almost a dozen new scientists under user fee appropriations, many with specific expertise in the area of microarrays, multiples testing, genetics, and genomics," Gutman said.

"We have also been well funded thanks to user fees, and [are] able to provide educational training to some of our more seasoned review staff. As a result I think we are unusually well positioned to handle these submissions with alacrity and skill," he added.

Gutman said companies that plan to submit an array-based IVD for clearance should meet with the FDA early, and referred possible applicants to a draft guidance on the OIVD web page dealing with multiplex testing and a draft concept paper on co-development of drugs and diagnostics. BioArray News' sister publication Pharmacogenomics Reporter covered the release of the draft guidance in March.

"These are not final documents, although both are being re-drafted based on comments to FDA, but [they] contain information that may be relevant to characterizing performance in these areas," Gutman said.

Gutman also recommended that prospective applicants review special controls for the Roche AmpliChip that have been published. He added that they could review the application for the AmpliChip and the accompanying Affymetrix reader on the OIVD web page in the 510(k) database.

— Justin Petrone ([email protected])

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