DNA leading the way

VISTA, Calif.—AutoGenomics Inc., a leader in automated microarray technology for molecular diagnostics, and Hartford, Conn.-based Genomas, a biomedical company enabling DNA-guided medicine for personal healthcare, have agreed to jointly develop genetic tests and DNA-guided diagnostic systems for optimal selection of statins and for improved delivery of statin therapy for the treatment of cardiovascular disease, obesity and diabetes. The collaboration will provide clinicians and physicians with newly developed genetic tests and a decision support system which will allow them to prescribe and dose statins on a personalized DNA basis to more effectively guide the therapy for each patient.

Statin drugs are among the most prescribed medications in the world and are used to reduce the level of low-density lipoprotein (LDL) cholesterol in the blood. AutoGenomics stated in the release announcing the collaboration that, according to the U.S. Centers for Disease Control and Prevention, there are currently more than 71 million American adults (over 20 years of age) with high LDL, and it is estimated that over 43 million Americans are currently prescribed the statin class of cholesterol-lowering drugs. However, statin LDL-lowering drugs can cause muscle aches, cramps and muscle weakness, and if not controlled, this can lead to muscular injury. The newly developed DNA-guided statin diagnostic tests are designed to identify individuals who are genetically susceptible to muscle pain (myalgia) while on statins and who may develop muscular injury (myopathy) while on high-dose statin therapy.

Fareed Kureshy, president and CEO of AutoGenomics, said, “Our INFINITI system in combination with Genomas’ SINM PhyzioType System will provide a reliable, reproducible, cost-effective platform for clinical laboratories to provide results and guidance to physicians to optimize treatment strategies for lipid disorders.”

Dr. Gualberto Ruano, president of Genomas and director of genetics research at Hartford Hospital putting his own spin on it, said, “The SINM PhyzioType System combined with AutoGenomics’ INFINITI multiplexing genetic test platform will enable cardiologists and clinicians to manage the variable lipid-altering efficacy and the risk of neuromuscular side effects that are prevalent in high-risk patients with heart disease and diabetes.”

The INFINITI High Throughput System was designed to provide semi-automated multiplexed DNA analysis in an open front-end system. The new platform provides highly flexible and scalable throughput from 96 to 3,456 samples tested in just one shift. The launch of this instrument is intended to meet the needs of the evolving genetic testing market, which now places a higher emphasis on throughput and scalability than just specialization alone. The INFINITI system is designed specifically for processing AutoGenomics’ unique proprietary BioFilmChip microarrays that can be multiplexed and configured with hundreds of biomarkers to assess disease signatures from a single sample specimen.

“The HTS allows us to meet the growing emphasis that modern molecular laboratories are placing on throughput and flexibility,” said Jim Canfield, the vice president of sales and marketing at AutoGenomics. “This new platform positions AutoGenomics to be the solution of choice for this new generation of power users.”

The new system is compatible with the existing menu of more than 50 INFINITI applications, including: HPV-HR, Bacterial vaginosis, Candida vaginitis, 2C19+, 2D6, 3A4/3A5, KRAS, BRAF, Ashkenazi Jewish Panel and Thrombo Panel.

Dr. Paul D. Thompson, chief of cardiology at the Henry Low Heart Center of Hartford Hospital, commented: “Growing evidence indicates that genetics determines who develops muscle complaints with statins. The partnership will allow us to pursue the final implementation studies of the multi-gene biomarker system to personalize cardiovascular therapy.”

AutoGenomics, based in Vista, Calif., designs, develops, manufactures and markets an automated, microarray-based multiplexing diagnostic platform that can be used to assess disease signatures with novel genomic and proteomic markers in the areas of personalized medicine, women’s health, oncology, genetic disorders and infectious disease.

Genomas is a biomedical company “delivering personalized medicine to modern clinical practice.” The company develops PhyzioType Systems for DNA-guided management and prescription of drugs used to treat mental illness, pain, heart disease and diabetes. PhyzioType Systems are designed to provide physicians with better capability to select for each patient the safest and most effective drug to achieve treatment goals and enhance patient compliance. PhyzioType Systems are composed of an ensemble of inherited DNA polymorphisms genotyped by arrays and interpreted by a bioclinical algorithm in order to convey to physicians predicted comparisons of side-effect risk and efficacy among drugs for the individual patient. The company’s clinical pharmacogenetic tests and consultation service are provided through its Laboratory of Personalized Health (LPH), an accredited and licensed high-complexity molecular diagnostic center, and its Personalized Health Portal (PHP), a medical informatics interface for clinician decision support. Genomas is located on the campus of Hartford Hospital in downtown Hartford, Conn.