QuantRx® Biomedical Corporation, a broad-based diagnostic company focused on the development and commercialization of innovative diagnostic products, has announced that the FDA has granted the Company 510(k) clearance on its RapidSense® drugs-of-abuse (DOA) Methamphetamine test.
The RapidSense Methamphetamine test is the first of QuantRx’ DOA tests based solely on its proprietary technology approved by the FDA. The RapidSense Methamphetamine test is a one-step positive read lateral flow device intended for use in the professional markets.
“The new clearance allows the Company to provide its customers with a new and innovative product for DOA testing, which we believe will complement our current sales efforts and allow us to expand beyond our traditional OEM product base,” stated Dr William Fleming, President of Diagnostics at QuantRx. “QuantRx Biomedical is well on its way to capitalizing on the burgeoning point-of-care testing markets with the clearance of its first DOA panel and we believe these markets offer tremendous near-term opportunities for QuantRx. QuantRx hopes to build upon its point-of-care franchise as it currently has over half a dozen additional lateral flow tests in the 510(k) pipeline.”
“We are pleased to have reached this important milestone,” stated Walter Witoshkin, QuantRx Chairman and CEO. “This is a clear signal that our RapidSense technology will bring real innovation to the broad US marketplace.”
“We anticipate this will be the first of multiple approvals from the FDA for our technology,” Witoshkin added.
