Enzo to Exclusively Offer Multigen's DNA-Based Antenatal Assays in NY in Second Half of 2010

By Kirell Lakhman

Enzo Biochem hopes to exclusively market certain antenatal infectious disease tests made by Multigen Diagnostics in New York and New Jersey sometime in the second half of the year, the companies said today.

Enzo will also seek CLIA validation for the multiplex DNA sequencing-based assay, which includes a thrombophilia panel. Enzo will also try to secure third-party reimbursement for the test, the companies said in a statement.

Multigen has also granted Enzo marketing rights for "other non-exclusive territories in US." The locations were not disclosed in a statement.

The tests would add to its menu of women’s-health diagnostics. The antenatal panel would simultaneously identify certain bacterial, viral, or fungal pathogens in a single specimen, while the thrombophilia panel would detect multiple mutations that can diagnose genetic predisposition to blood clotting.

In the statement, Enzo said "it hopes to make the test available in the second half of 2010," but that goal is "subject to regulatory and reimbursement approval, among other" requirements.