Genomas, a biomedical company advancing DNA-guided medicine and personalized healthcare, has announced the award of a Fast-Track Phase I-II Small Business Innovation Research (SBIR) Grant totaling $1.2 million.
The grant, entitled "DNA Diagnostic System for Statin Safety and Efficacy," was awarded by the National Institute of General Medical Sciences (NIGMS).
Statins are the most prescribed drugs in the world. Drugs in this class include atorvastatin (Lipitor(R)), rosuvastatin (Crestor(R)), and simvastatin (Zocor(R) and generic formulations). Statin-induced neuro-myopathy (SINM) is the main clinically relevant safety risk of these drugs. In medical practice, SINM presents as a constellation of nerve and muscle side effects. Clinical symptoms of SINM include muscle aches (myalgia), cramps, weakness, and muscle injury (myositis, monitored in serum by elevation of certain enzymes). Statin usage is ultimately limited by these side effects which are disabling to 10% of patients, require alteration of therapy, burden healthcare with management costs, and reduce compliance.
Under the SBIR program, Genomas will integrate the clinical expertise of its strategic partner, Hartford Hospital, with the company's proprietary physiogenomics technology to develop DNA-guided clinical management systems that predict and compare an individual's risk of SINM from statin medications. PhyzioType(TM) Clinical Management Systems are composed of an ensemble of inherited DNA markers genotyped by arrays and interpreted by a biomathematical algorithm in order to convey to physicians predicted comparisons of side effect risk among drugs for the individual patient.