GenPrime Receives FDA Clearances
March 04, 2014
SPOKANE, WA, March 4, 2014 – GenPrime, Inc., a downtown-headquartered biotech company, received the first FDA clearances on its software-based medical-device platform, the D-Cipher.
The FDA has cleared GenPrime to begin marketing its technology in the United States for the detection of Drugs of Abuse (including; Amphetamine, Barbiturates, Cocaine, Methamphetamine, Methadone, Morphine, Oxycodone, PCP and THC, the active ingredient in marijuana). The clinical trials were performed in partnership with PAML (Pathology Associates Medical Laboratories), whose Patient Service Centers performed the third party evaluations of the device.
The D-Cipher Platform is based on novel image analysis algorithms. Using a small scanner, high resolution 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.
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 D-Cipher 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 opens the door to the U.S. Drugs of Abuse markets which make up approximately 2/3 of the global market for this type of testing," says McLean. "This is obviously a huge growth opportunity for our company."
GenPrime plans to aggressively continue expansion of the D-Cipher 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.