Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted on the difficulties facing some laboratories in complying with the U.S. Food and Drug Administration’s analyte specific reagent policy guidelines, which were clarified in 2007.
Manufacturers and laboratories have until September to begin complying with the guidelines, but some labs, particularly those specializing in molecular diagnostics, are scrambling to fill what could be a gap in needed supplies.
In the article, “Contracting Out Gives Laboratories An In With Diagnostics Manufacturers,” Thompson pointed to one solution that holds advantages for both companies and labs but has been overlooked: contract manufacturing. This allows a laboratory to design an assay, and then commission a device-maker to produce the test kit and sell it back to the lab.
“It is another relationship between lab and manufacturer where the lab is the innovator, but the manufacturer does more than just make one of these frustratingly narrow ASRs [analyte specific reagents],” said Thompson, speaking at the Association of Medical Diagnostics Manufacturers annual meeting in Bethesda, Md., April 24.
ASRs are chemical or biological “ingredients,” such as a single antibody or gene sequence, that companies can make and sell without FDA pre-market review. Labs or other manufacturers can use ASRs to construct full test system.