NEW YORK (GenomeWeb News) – Roche Diagnostics has terminated a sales and distribution deal with Response Biomedical after the Canadian diagnostic test maker failed to get US regulatory clearance of its cardiovascular tests on its most current platform, Response Bio announced today.
In a statement the company said that the deal, originally forged in June 2008, called for Roche to distribute its cardiovascular point-of-care tests on the Ramp 200 platform, but Roche is terminating the agreement after Response Bio failed to receive clearance from the US Food and Drug Administration.
The FDA told Response Bio in May that its NTproBNP assay for the diagnosis of heart failure would not receive 510(k) clearance to run on the Ramp 200 system. FDA had cleared the assay to run on the earlier version of the Ramp instrument in 2008.
FDA additionally told the company in June that the assay failed to meet criteria to obtain a waiver under CLIA rules.
Response Bio said today that upon reviewing FDA's ruling, it has determined that its assays for NTproBNP, troponin, myoglobin, and CK-MD, while cleared for sale in the US on the Ramp Reader, "would need to have new FDA submissions approved to allow [for] sale in the US on the Ramp 200 Reader."
It said that it is considering other options to seek partners to market NTproBNP on the Ramp Reader and to obtain US clearance of the panel on the Ramp 200 system. It will continue to market NTproBNP on the Ramp 200 and Ramp Reader systems outside the US, as well as the Ramp Flu A/B assay and Ramp RSV assay on the Ramp 200 system in geographies where they have received regulatory approval, the company added.
Response Bio said that the termination of the Roche contract is not expected to materially affect its financial results for 2011. Last month the company reported a 17 percent rise in second-quarter revenues. Shortly after announcing its earnings results and disclosing its failure to received FDA approval of the cardiovascular panel on the Ramp 200, Wayne Kay resigned from the company as CEO and as a director.