GenPrime Inc., a biotech company based in downtown Spokane, says it has launched domestic sales of a point-of-care diagnostic device for workplace drug testing, called the POC Reader, with partner company Alere Inc., of Waltham, Pa.

GenPrime says it and Alere developed a commercial partnership last year under which eScreen Inc., a wholly owned subsidiary of Alere, secured the rights to sell GenPrime’s reader in the U.S. market under the brand name xReader.

 The Spokane company earlier had received U.S. Food and Drug Administration approval to market its technology for the detection of what are called “drugs of abuse,” such as amphetamines, barbiturates, cocaine, and opiates.

GenPrime’s system uses what are called lateral-flow test strips for diagnostic screening, similar in function to an at-home pregnancy test, and its reader is configured to detect multiple drug metabolites simultaneously in human urine. 

The high-resolution electronic reader—employing GenPrime’s algorithms—captures images from test devices and logs results and images automatically, removing all subjective interpretation of the results, as occurs with typical operator-interpreted tests, the company claims.

The automatic recording of test results and images prevents clerical errors that can occur while completing chain-of-custody forms or reentering data into archives, it asserts on its website. 

Also, thanks to a searchable database, clinicians can export and email results with the click of the mouse, it says.

“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,” says Darby McLean, GenPrime’s COO, in a press release about the launch of the device.

eScreen has begun rolling out the xReader to its large end-user base of collection sites and diagnostic service providers, the release says. With the xReader, it says, eScreen is able to expand its menu of tests from five to 11 drugs, thus broadening the potential market it can serve.

Lateral-flow-based tests are used in hospitals, clinics, physician offices, and clinical laboratories for rapid diagnostics involving a variety of biological samples, including urine, tears, sweat, saliva, serum, plasma, whole blood, and biopsied tissue and fluids, GenPrime says.

Such tests also are used in veterinary medicine and for quality control to ensure product safety in food production, environmental test, water safety, and pharmaceutical and biologics manufacturing, it says. Along with abused drugs, major clinical markets include cardiac marker diagnostics, fertility testing, and infectious disease and oncology diagnostics, it says.

The POC Reader platform was launched in Italy in 2010, and since then more than 1,000 systems have been placed throughout the European toxicology market, GenPrime says.

Buck Somes, the company’s CEO, says in the release, “FDA clearance of this product opened the door to the U.S. toxicology market, which makes up approximately two-thirds of the global market for this type of testing. This is obviously a huge growth opportunity for our company.”