GeninCode PLC (LSE: GENI.L), a U.K.-based predictive genetics company focused on the prevention of cardiovascular disease with its U.S. headquarters in Irvine, is looking to up its domestic presence.
The medtech company said last month that it may get the Food and Drug Administration’s greenlight for its new cardiovascular disease risk assessment test, the Cardio inCode-Score (CIC-SCORE), within the next six months.
The regulatory approval “will complement our U.S. laboratory testing, enabling GeninCode to accelerate commercial growth of CIC-SCORE in the U.S. market,” CEO Matthew Walls said.
CLIA Approval
GeninCode operates out of a portion of a roughly 20,000-square-foot facility in the Spectrum area of Irvine, not far from the local base of chipmaking giant Broadcom Inc. (Nasdaq: AVGO).
The building is home to ResearchDX, a contract diagnostics firm, and previously held the headquarters of Bioniz Therapeutics, a clinical-stage biopharmaceutical company that was acquired last year by Equillium in a deal worth up to $329 million.
Last year, GeninCode commissioned the lab for the Irvine site and applied for and received California State Licensing approval and subsequently CLIA (Clinical Laboratory Improvement Amendments) regulatory approval, the company said in its latest annual report.
CLIA approval enables the company, which counts six employees in Irvine, to start selling its lab diagnostic tests in the U.S. market.
Genetics Approach
The company’s CIC-SCORE examines patients’ genetic makeup to determine their risk of heart disease.
Genetics make a 50% contribution to the development of cardiovascular issues, according to scientific research cited by GeninCode. Heart disease is the leading cause of death in the U.S.; one person dies as a result every 33 seconds, the CDC says.
The company has spent the last 15 years developing data for their first products coming to market, including a study on CIC-SCORE with Kaiser Permanente involving 60,000 patients in California over an eight-year period.
CIC-SCORE uses a blood or saliva sample to assess patients’ genetic variations, called single nucleotide polymorphisms. The turn-around time for results ranges from two to four weeks.
Traditional assessments of patient risk for heart attack and stroke involve visiting a physician and reviewing clinical risk factors such as physical activity and lifestyle. CIC-SCORE brings genetic insight to physicians directly via an online cloud-based system called SITAB.
“What you’ll see in the next five to 10 years is the beginning of genetics coming in alongside the clinical risk assessment with our product at the forefront,” CEO Walls told the Business Journal.
The company went public two years ago on the London Stock Exchange, raising close to $20 million.
At press time, shares in GeninCode were $12.25 apiece for a market cap of $12.1 million.
