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Pillar Biosciences Gets CLIA Certification for Sequencing Clinical Lab

NEW YORK — Cancer diagnostics developer Pillar Biosciences said on Thursday that it has received CLIA certification for its next-generation sequencing clinical laboratory.

According to the Natick, Massachusetts-based company, the certification allows the lab to support preclinical studies and clinical trials, as well as to potentially provide companion diagnostics for its 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," Pillar CEO Randy Pritchard said in a statement. "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."

In 2019, Pillar partnered with China Biotech Services Holdings to establish a joint venture to provide precision diagnostic products and services to Hong Kong, Macau, South Korea, and Southeast Asia, as well as distribute Pillar's products in parts of China.

In mid-2021, the company received US Food and Drug Administration premarket approval for its OncoReveal Dx Lung and Colon Cancer Assay, a next-generation sequencing, tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA from non-small cell lung cancer and colorectal cancer tissue samples.