Back in January, Woodlands, Texas-based MolecularHealth announced that it had entered into a unique agreement with leading DNA sequencing service provider GATC Biotech in order to provide protocols support and extensive training of MolecularHealth’s laboratory staff at their new office and lab in The Woodlands. In a bid to continue to enhance the profile of the company’s lab and data processing facilities, MolecularHealth has now announced that it has received CLIA certification for its clinical lab in the Houston area.
The CLIA certification recognizes two critical tests that the lab will offer: “a targeted gene panel of more than 500 known cancer genes, and whole exome sequencing of the tumor genome,” according to a company press release.
Gaining the Clinical Laboratory Improvement Amendments (CLIA) certification from the Centers for Medicare & Medicaid Services (CMS) is a key milestone for the company, since the CMS regulates all laboratory testing (with the exception of research) related to human health and biology in the U.S. The CLIA certification is considered to be a gold standard for biotech and life sciences entities, as it currently covers approximately 239,000 labs throughout the country. 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 sees the CLIA program certification as an important step in establishing the company’s approach to “end-to-end service.” Throughout the course of the company’s launch, they have worked toward building both the customer service and technical ends of their offerings, from strategic executive hirings to key partnerships with companies such as GATC, who are helping to bolster their clinical operations. The end result will be a comprehensive 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.”
Dr. Shelly Gunn, chief medical officer for MolecularHealth, characterizes this news as a critical step in the formation of the company: “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. 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.”