On August 22, 2022 Pillar Biosciences, the leader in Decision Medicine, developers and distributors of next-generation sequencing (NGS) tests which localize testing and reduce time to treatment initiation and overall testing costs, reported that its oncoRevealTM Dx Colon Cancer Assay has received approval from the China National Medical Products Administration (NMPA) (Press release, Pillar Biosciences, AUG 22, 2022, View Source [SID1234618553]). The IVD assay is now commercially available in China, the U.S., and Europe as a companion diagnostic (CDx) to identify patients with colorectal cancer whose tumors express wild-type KRAS status and may benefit from treatment with specific targeted therapies.
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"The oncoReveal Dx Colon Cancer Assay localizes NGS testing and efficiently provides a highly accurate genetic profile of KRAS mutations in metastatic colorectal cancer patients," said Randy Pritchard, Chief Executive Officer of Pillar Biosciences. "This approval is important for oncologists across China who need a more streamlined, efficient and accurate means of identifying the right therapy for their individual patients. By making testing more widely available, and enabling faster results, we can significantly reduce the amount of time it takes to initiate treatment and enable patients to more confidently continue along their life journey."
The oncoReveal Dx Colon Cancer Assay is a companion diagnostic test that identifies patients with metastatic colorectal cancer who have KRAS wild-type tumor status and may benefit from treatment with approved therapies, Erbitux (cetuximab) or Vectibix (panitumumab). The assay utilizes Pillar’s highly accurate and sensitive SLIMamp NGS testing technology to generate data that optimizes selection of precision therapies for cancer patients. This is the Company’s first NMPA approved diagnostic product. Pillar’s oncoReveal Dx Lung & Colon Cancer Assay previously received CE-IVD certification in Europe in April 2020 and U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) in July 2021.