NEW YORK (GenomeWeb News) — Prodesse said today it will stop selling three of its multiplex ASR products in the US Aug. 1 as it transitions them into in vitro diagnostics in light of a recent US Food and Drug Administration draft guidance.
The company said it plans to remove the underlying supermixes for its Hexaplex, Hexaplex Plus, and ProPneumo-1 products as part of an “orderly transition” from ASRs to IVD assays.
“Though the actual ASR regulations have not changed, the September 2006 ASR draft guidance documents clearly show that the FDA’s posture towards ASRs has changed,” Prodesse CEO Tom Shannon said in a statement.
”Our company prefers to clear up any ambiguity in our customers' minds by moving from ASRs to IVDs,” Shannon added.
The company said its ProFlu+ test for influenza A, B, and RSV has completed clinical trials and a 510(k) application will “shortly” be submitted for FDA clearance.
The FDA has also received a pre-IDE submission on Prodesse’s Pro hMPV+ test for human metapneumovirus. More studies are in the planning stages, Prodesse said.