GenPrime Launches Medical Device in the U.S. Toxicology Market
August 24, 2016
SPOKANE, WA, August 26, 2016 – GenPrime, Inc., a Spokane based biotech company, launched its FDA cleared Point of Care (POC) diagnostic medical device, the POC Reader, in the $1.2B U.S. drug testing market with its partner company, Alere, Inc. based in Waltham, MA.
In 2015, GenPrime and Alere developed a commercial partnership whereby Alere’s wholly owned subsidiary, eScreen, Inc. has secured the rights to sell GenPrime’s POC Reader in the U.S. work-place drug testing market under the brand name xReader. GenPrime received clearance from the FDA to market its technology in the United States for the detection of Drugs of Abuse (including; Amphetamine, Barbiturates, Benzodiazapine, Cocaine, Methamphetamine, Methadone, Opiates (2), Oxycodone, PCP and THC). The clinical trials were performed in partnership with Alere and Spokane-based PAML (Pathology Associates Medical Laboratories), whose Patient Service Centers performed the third party evaluations.
GenPrime’s POC Reader Platform is based on novel image analysis algorithms. Using a high resolution scanner, images of Lateral Flow (LF) test devices are captured and analyzed. Results of these typically operator interpreted tests are now digitally analyzed and reported electronically, thus removing all subjective interpretation of results. “We are now able to connect a traditionally disconnected part of health care to multiple digital information platforms, including Laboratory Information Systems and Electronic Medical Records.” reports Darby McLean, GenPrime’s Chief Operations Officer.
eScreen has begun rolling out the xReader to its large end-user base of collection sites and service providers. With the xReader, eScreen is able to expand their menu of tests from 5 to 11 drugs, thus broadening the market they can serve.
In hospitals, clinics, physician offices, and clinical laboratories, LF-based tests are used for rapid diagnostics in a wide variety of biological samples including: urine, tears, sweat, saliva, serum, plasma, whole blood, and biopsied tissue and fluids. LF-based tests are also used in veterinary medicine and for quality control and to assure product safety in food production, environmental testing, water safety, and pharmaceutical and biologics manufacturing. Major clinical markets include: drugs of abuse, cardiac marker diagnostics, fertility testing, infectious disease diagnostics and oncology diagnostics.
The POC Reader Platform is fully developed and was initially launched in Italy in 2010. Since then, nearly 1000 Systems have been placed throughout the European toxicology market. “FDA clearance of this product opened the door to the U.S. Toxicology market which makes up approximately 2/3 of the global market for this type of testing” says Buck Somes, CEO of GenPrime. “This is obviously a huge growth opportunity for our company”.
GenPrime plans to aggressively continue expansion of the POC Reader Platform. The next applications will include Infectious Disease, Women’s Health, and Cancer marker testing. This product represents tremendous growth potential for the Company. There are roughly 250 million LF tests performed each year.
GenPrime has proven its capability to develop and commercialize products that address critical market needs. Legacy products include the Prime Alert bio warfare agent detector which is currently used by the United States Postal Inspection Service and the Air National Guard. These accomplishments have given GenPrime a growing, diverse intellectual property base and product pipeline.
GenPrime is committed to becoming the leading provider of advanced testing technologies for a secure and healthy world. For additional information, contact GenPrime, Inc.
502 W. Riverside Ste #101 Spokane, WA 99201 USA
Phone: 1.509.624.9855, Toll Free: 1.866.624.9855
E-mail: dmclean@genprime.com