THE WOODLANDS, Texas--(BUSINESS WIRE)--MolecularHealth announced today that it has received CLIA certification for its clinical lab in the Houston metro area. Under this certification, the lab will offer two tests: a targeted gene panel of more than 500 known cancer genes, and whole exome sequencing of the tumor genome. These tests are an important part of the company’s end-to-end service, which walks patients and their healthcare providers through the molecular diagnostic process—collecting tumor samples, analyzing the samples, and interpreting the results using a unique analytics platform—all to generate safer and more targeted cancer treatment choices.
“Our team has done a great deal of work to design a world-class next generation sequencing lab that will support our molecular diagnostic platform,” said Dr. Shelly Gunn, chief medical officer for MolecularHealth. “Now that our certification is complete, we’ll soon be able to begin receiving and analyzing samples in order to provide oncologists and pathologists with personalized information on their patients’ tumors.”
Dr. Lloyd Everson, CEO of MolecularHealth, added, “Our laboratory services, focused on next generation sequencing (NGS) of cancer, is a key piece of our offering. As we begin to offer our services to oncologists, pathologists and the biopharma industry, having a CLIA certified lab in place is a necessity for providing the highest quality of NGS for cancer patients.”
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 239,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.
MolecularHealth delivers on the promise of personalized, precision medicine. By using advanced proprietary information technologies to sift through terabytes of genetic and molecular test findings in a fraction of the time needed for current manual analysis, MolecularHealth provides doctors and patients with faster, more accurate insights into the role genes play in the progression and treatment of an individual’s cancer. MolecularHealth’s team of doctors, scientists, IT and business experts—including founders and executives of LION Bioscience, US Oncology and Novartis—works in partnership with some of the world’s leading healthcare and information technology companies, including the University of Texas MD Anderson Cancer Center, SAP AG, and the U.S. Food and Drug Administration (FDA). The company has locations in The Woodlands, Texas, Boston, Mass. and Heidelberg, Germany. Visit www.molecularhealth.com for more information.