GenPrime Inc., a biotech company based in downtown Spokane, expects later this month to launch sales domestically of a medical device it has developed to test for drug abuse, following recent approval of its technology by the U.S. Food and Drug Administration.

The company has sold its product, known as the D-Cipher drug screen platform, in Europe since 2010. Overseas, it has 1,000 units in use, says Darby McLean, GenPrime’s chief operating officer.

“The U.S. market is so much larger,” McLean says. “We are working with a partner company for U.S. distribution. We’re not quite ready to disclose the terms of that arrangement, but it’s near term. I’d say in the next 30 days, we’ll be able to begin sales.”

She adds, “We expect sales in the first year to be more than double the current sales in Europe to date.”

McLean says GenPrime and its partner company plan to market D-Cipher to laboratories that conduct third-party drug testing, to physician offices, and to employers who perform workplace testing. She says the devices will be free or carry a negligent cost. GenPrime will derive income from use of the device’s software, garnering a royalty each time the system produces a test result, she says. The partner company will gain revenue from selling the disposable drug test kits designed for use with the system.

“The company we’re working with has a much larger presence in the marketplace,” McLean says. “GenPrime will maintain its identity as the manufacturer and regulatory owner. We’ll be the interface, and the partner will help with sales and distribution.” 

D-Cipher is designed as a rapid, one-step testing system that can detect drugs in human urine. It’s designed to detect a wide range of drugs that include methamphetamine, cocaine, barbiturates, and marijuana.

GenPrime’s system employs a single-use, disposable cup outfitted with what are called lateral-flow test strips for diagnostic screening, similar in function to an at-home pregnancy test. The D-Cipher test strips are embedded to interface with an electronic reader that has a small scanner so that high-resolution images of lateral-flow tests are captured and digitally analyzed. The system that includes GenPrime’s software automatically logs the results into a database.

To gain the FDA approval awarded in January, GenPrime partnered with Spokane-based Pathology Associates Medical Laboratories LLC to conduct a year-long clinical trial of the system to satisfy the agency’s requirements. 

 “We have the first reader in toxicology to be approved by the FDA in the last 10 years,” McLean says. “It’s such a rigorous process. We’ve had some competitors that tried and couldn’t get through.”

Founded in 1997, the privately-held GenPrime has developed other advanced biotech test kits, including its Prime Alert system to detect toxins such as anthrax and ricin. GenPrime operates with 15 employees at 502 W. Riverside, inside of the former Sherwood Building, now called the Numerica Building.

McLean says the new D-Cipher test platform has a wider potential application to detect infectious diseases and for other screening diagnostics. She adds that one example would be to test for the presence of flu strains from analysis of nasal swabs. 

However, McLean says using the system to screen for diseases and to do other categories of diagnostic testing would require additional FDA approval.

GenPrime’s Prime Alert does rapid-detection testing for substances that might pose a potential biological threat. The Prime Alert units sell for about $12,500, and they’re sold to clients that include the U.S. Postal Inspection Service, hazmat teams, and the Air National Guard, McLean says. 

She says the company partners with Edgewood, Md.-based Smiths Detection as the distributor of Prime Alert.

GenPrime’s only other current product is a yeast activity monitor used by breweries and for ethanol production. The company partners with Naperville, Ill.-based Nalco Co., a division of Echolab Inc., for distribution of that monitor.

McLean says GenPrime started with support from Sirti, the Spokane-based, technology-focused agency that later became part of Innovate Washington, a statewide tech-business catalyst. She says GenPrime today is growing, but she declines to disclose the company’s revenue.

“We have been profitable,” she says. “I think we’ll be adding to our team both in our lab and potentially in our software development department.” 

 In the past, she says, lateral-flow test strips were interpreted visually by an individual typically in a lab, and the results could be subjective.

“With our platform, these are read electronically and data is automatically transferred,” McLean says. “Our software makes the interpretation, rather than the person. It takes subjectivity and human error out.”