GenPrime’s quick drug test gets OK for sale from FDA
D-Cipher will be marketed to hospitals, employers
Federal officials have given the green light for Spokane biotech firm GenPrime to market a test kit that can help hospitals and employers conduct rapid tests for illegal drugs.
The test system, called D-Cipher, has taken two years for testing and approval by the U.S. Federal Drug Administration.
It will be marketed to hospitals, human resources departments and other point-of-care centers where rapid identification of drugs is critical, said Darby McLean, GenPrime’s chief operating officer.
GenPrime will provide the software component, while a partner company is developing the hardware and scanner system for D-Cipher.
The past year of testing was done to establish at least 95 percent accuracy for substances being diagnosed, McLean said.
The initial D-Cipher kit is designed to test for amphetamine, barbiturates, cocaine, methamphetamine, Methadone, morphine, Oxycodone, PCP and THC, the active ingredient in marijuana.
One use would be in hospitals or emergency rooms where doctors would test to ensure patients were not using those drugs before being given new prescriptions, McLean said.
The D-Cipher system’s most basic component is a plastic cup lined with test strips into which a person being tested urinates. Using a small scanner, high-resolution images of the chemical reactions on the assay strips are captured and analyzed.
GenPrime’s software determines both the type of substance present and its density, McLean said.
The testing hardware devices and scanners will be made available to customers at essentially no cost. Revenue from D-Cipher will come from the sale of testing kits, she said.
Other uses for D-Cipher include infectious disease, women’s health and cancer marker testing, McLean said.