NATICK, Mass.--(BUSINESS WIRE)--Pillar Biosciences, an innovative, next-generation sequencing (NGS) solutions, in-vitro diagnostics (IVD) company, today announced that its NGS laboratory, located in Natick, Massachusetts, has passed the onsite inspection and received Clinical Laboratory Improvement Amendment (CLIA) certification from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS), as well as the Massachusetts state permit. This certification enables the lab to support pre-clinical studies and clinical trials, with the longer-term potential to provide companion diagnostics, for Pillar Biosciences’ pharmaceutical partners.
"The receipt of CLIA certification is an important benchmark, providing tangible evidence of Pillar’s standards of quality for accurate, consistent, and fast testing,” said Randy Pritchard, CEO of Pillar Biosciences. “Importantly, with this CLIA lab, plus our facility in China, Pillar’s ability to support companion diagnostics partners is now a truly global offering, with expanded reach and deep capabilities that can help companies in the pharmaceutical industry best serve their customers.”
CLIA certification affirms that Pillar Biosciences’ lab operates under high quality standards and generates accurate, reliable, and timely tests and data to support clinical trials. Holding IVD manufacturing capacity, and CLIA-certified laboratories in both the U.S. and China positions Pillar Biosciences as an attractive partner for any pharmaceutical company seeking to leverage its innovative NGS technology for global, multi-center clinical trials and potential companion diagnostics. Pillar Biosciences will also utilize its lab to support the development and validation of its NGS products.
About Pillar Biosciences
Pillar Biosciences is a global oncology solutions company delivering in-vitro diagnostics (IVD) that provide accurate, robust, timely, clinically actionable insights to guide treatment decisions throughout a patient’s continuum of care. We power the oncology ecosystem with our proprietary, automatable, NGS platform agnostic, SLIMamp® and PiVAT® technologies with a simplified workflow to expedite the delivery of robust and dependable clinical test results.
Our mission is to enable access to high quality, affordable, specialty NGS testing, performed by any NGS laboratory as clinical grade tests, closer to home, for all patients. Pillar has operations in Natick, MA and Shanghai, China. For more information, visit www.pillar-biosciences.com.