Premier Medical Laboratory Services has announced the U.S. launch of the Diabetespredict test, which provides a genetic risk score for predisposition to type 2 disease based on testing of a cheek swab or blood sample for 16 single nucleotide polymorphisms (SNPs).
The test was developed by Patia, which is based in San Sebastián, Spain, and had already been launched in Europe and Mexico. According to Patia, the test was developed based on studies of 110,000 people with and without diabetes. In addition to the risk score, the product includes a customized report advising lifestyle modifications that can be made in light of the genetic results to track adherence with preventive plans.
Greenville, SC-based Premier Medical Laboratory Services said it is offering the test throughout the U.S. The cost with insurance varies depending on the carrier, but the rule of thumb is the Medicare price of $1,044.31, according to the company. Self-pay patients would get a discounted cash price of $299. The company is hosting webinars about the product in August and September.
The U.S. market for diabetes testing is potentially very large. An estimated 84 million adults -- more than one-third of the population -- have prediabetes, which signifies an increased risk for type 2 diabetes, heart disease, and stroke, according to the U.S. Centers for Disease Control and Prevention.
But the good news is that studies show prediabetes can be tackled and reversed with lifestyle modifications, including in people with genetic risk factors. In a study of 111,765 people in China, researchers reported that participants with prediabetes or diabetes who also had five or more "ideal cardiovascular health metrics" had lower or no increased cardiovascular risk than those who had normal glucose regulation (Wang et al, JAMA Cardiology, July 31, 2019).
Developed by a task force of the American Heart Association, ideal cardiovascular health metrics include measures related to cholesterol levels and body mass index.
In addition to Premier Medical Laboratory Services, GX Sciences is also offering Patia's diabetes risk test in the U.S. Other tests available in the U.S. include 23andMe's type 2 diabetes polygenic risk score and report, which was unveiled in March and the company said is informed by data from more than 2.5 million of its customers.