NEW YORK, March 17 (GenomeWeb News) - Eli Lilly and ParAllele plan to enable contract research organizations to use their joint genotyping assay in August or September, a Lilly official told Pharmacogenomics Reporter, GenomeWeb News' sister publication, this week.
The assay, tentatively called MegAllele D-Met, will run on Affymetrix's GeneChip platform, and the CROs will initially use it to genotype every one of Lilly's clinical trial participants, said Rick Hockett, medical fellow group leader of genomic medicine at the drug maker.
ParAllele, meantime, said it plans to file the product with the US Food and Drug Administration within the next 12 months with the aim of marketing it as an in vitro diagnostic, said Aaron Solomon, vice president of business development at ParAllele, told Pharmacogenomics Reporter.
The assay, which will become a ParAllele product under its agreement with Lilly, interrogates "about 1,500 SNPs" in approximately 170 genes related to drug metabolism and transport, said Solomon. These genes include "all known" CYP450 enzymes, non-cytochrome enzymes -- such as acetylases and transferases -- and transport proteins, Hockett said.
The assay ParAllele will submit to the FDA, and will eventually market, will contain a smaller number of SNPs than the original D-Met assay, Solomon said.
Hockett said he "is trying to convince ParAllele and the CROs that this has to be cost-effective. We're trying to force the retail price for this to be somewhere in the $500 to $700 range per test."