It has been almost one month since Affymetrix was to file its drug-metabolism assay with the US Food and Drug Administration for clearance as an in vitro diagnostic, and Affy is being secretive about its status.
ParAllele developed the test, which it dubbed Megallele, last year with Eli Lilly and planned to file it with the FDA in March, Aaron Solomon, vice president of business development at ParAllele, told Pharmacogenomics Reporter last year. The company, which was acquired by Affy in October 2005, aimed to market the assay as an in vitro diagnostic, he said.
An Affymetrix spokesperson declined to provide details on its plans for the assay, which Affy renamed the GeneChip DMET.
All that Affy would say is that a "service is currently available for customers interested in markers that are known to play a role in drug metabolism," according to Jay Kaufman, Affymetrix director of product marketing for DNA analysis.
"Affymetrix is engaged in ongoing research collaborations with leading pharmaceutical companies, such as Eli Lilly, and continues to explore the commercial market opportunities around the development of a DMET assay kit," Kaufman told Pharmacogenomics Reporter via email.
Affy officials declined to say how long the service has been in operation.
Rick Hockett, medical fellow group leader of genomic medicine at Eli Lilly, said last March that Lilly intended to launch the assay through contract research organizations in August or September 2005, The CROs were to use the assay in Lilly's drug-discovery studies.
ParAllele's Solomon estimated last year that the company will file the assay with the FDA in 12 months. The company had hoped to launch the test initially in the research market, where it could be used in as many as 1 million genotyping assays in the United States annually, based on the number and size of clinical trials, he said. Parallele had not developed a formal estimate of the clinical market, Solomon added.
If it has been filed with the FDA, and is approved, the GeneChip DMET may become a competitor to Roche Molecular Diagnostics' AmpliChip CYP450 test, which also runs on Affy's GeneChip reader.
But while the two tests have some overlap, it is not clear that they will address exactly the same market. It appears that Amplichip is more suited to small-scale diagnostics, while DMET may be better attuned to the needs of organizations running clinical trials.
AmpliChip interrogates SNPs connected to the genes CYP450 2D6 and CYP450 2C19, while the DMET assay interrogates CYP450 enzymes; non-cytochrome enzymes, such as acetylases and transferases; and transporter genes, according to Lilly's Hockett.
However, ParAllele planned to release a smaller product for in vitro diagnostic use, and perhaps Affy has kept that idea alive. "We'll be looking at this technology to access many of the different niche opportunities that reside out there that can be consolidated under a technology, and in the long term, of course, into the regulated market," said Greg Schiffman, Affymetrix's CFO, during a conference call in late May.
While it was under development by ParAllele and Lilly, there were "roughly 29 genes" on the assay.
Under Affy, the DMET panel includes "approximately 1,200 polymorphisms from more than 150 genes," according to an Affy spokesperson.
— Chris Womack ([email protected])