Admera Health, South Plainfield, NJ, has launched the AtheroGxOne panel test following its approval by the New Jersey Department of Health. AtheroGxOne is a comprehensive next-generation sequencing (NGS)-based 84-gene panel aimed at identifying patients with a genetic signature for inherited premature coronary or atherosclerotic disease, such as familial hypercholesterolemia (FH), as well as mature onset diabetes of the young (MODY).
If left untreated, alterations in the panel’s genes can affect the metabolism of lipids and carbohydrates and lead to early atherosclerosis. These diseases have a significant impact on cardiovascular risk since they appear at an early age and indicate a poor prognosis without aggressive medical intervention. In fact, approximately 5% and 20% of myocardial infarctions in individuals under 60 and 45 years of age, respectively, are due to alterations in the genes included in the panel.
The panel can detect FH, a genetic disorder that is characterized by high cholesterol levels, specifically very high low-density lipoprotein. FH affects 1 in 500 people, making them less likely to respond to such usual interventions as dietary modification or statin use. But they may be eligible for a new generation of PCSK9 inhibitor drugs.
Developed as a joint venture between Admera Health and Health In Code (HIC), the panel test detects genomic variations associated with FH, hypolipidemia, mixed hyperlipidemia, and MODY. A comprehensive interpretive report is generated based on the integration of test results with genetic and clinical information from HIC’s proprietary knowledge base containing more than 85,000 individuals. Reviewed by expert cardiologists specialized in genetics, test results provide cardiologists with genetic interpretation for risk assessment and disease diagnosis.
“The approval of our AtheroGxOne test demonstrates once again the company’s ability to coordinate our research and development efforts with the work of our external partners to rapidly develop a . . . product that meets important unmet clinical needs,” says Guanghui Hu, PhD, president and CEO of Admera Health. “This new product, together with our other cardiovascular portfolio products, will help our company successfully meet or exceed our financial goals for the new year.”
“AtheroGxOne allows cardiologists to pinpoint genetic factors to help diagnose cholesterol and other lipid disorders, including FH, at a much earlier phase of disease, opening up the potential for earlier medical intervention that can save lives,” adds Zeil Rosenberg, MD, vice president for medical affairs at Admera Health. “In addition, for endocrinologists, the panel provides genetic information for risk of MODY, where children otherwise diagnosed with insulin-dependent diabetes can be taken off insulin and managed medically, avoiding a lifetime of injection therapy and increased risk of cardiovascular disease. Launch of the test marks a milestone in Admera Health’s portfolio expansion to meet the expressed needs of cardiologists to diagnose and manage patients at risk for inherited cardiovascular disease.”
For more information, visit Admera Health.