Pillar Biosciences Receives China National Medical Products Administration (NMPA) Approval for oncoRevealTM Dx Colon Cancer Assay

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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, today announced that its oncoRevealTM Dx Colon Cancer Assay has received approval from the China National Medical Products Administration (NMPA).

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Monday, August 22, 2022
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Biotechnology, Pharmaceutical, Medical Supplies, Oncology, General Health, Health, Genetics, Clinical Trials, Pillar, Technology, Cancer, Oncology, Food and Drug Administration, National Medical Products Administration, NGS, Recurrence, Food, Physician, Marie Cassidy, IVD, NMPA, Cetuximab, KRAS, Company, PMA, FDA, Cdx, Certification, Neoplasm, Efficiency, RUO, List of life sciences, Liquid biopsy, Panitumumab, Colorectal cancer, Patient, Pharmaceutical industry, Medical imaging
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MASSACHUSETTS, CHINA, UNITED STATES, NORTH AMERICA, ASIA PACIFIC, EUROPE, MA
Summary
Key Points: 
  • 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, today announced that its oncoRevealTM Dx Colon Cancer Assay has received approval from the China National Medical Products Administration (NMPA).
  • 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.
  • Pillars 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.


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, today announced that its oncoRevealTM Dx Colon Cancer Assay has received approval from the China National Medical Products Administration (NMPA). 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.

“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.

About Pillar Biosciences

Pillar Biosciences is the leader in Decision Medicine™, which is the utilization of highly accurate and sensitive next-generation sequencing (NGS) testing technology to generate data that optimizes selection of precision therapies for cancer patients, from tumor profiling to therapy selection, and recurrence monitoring. Pillar’s NGS testing solutions, including the FDA-approved oncoReveal™ Dx Lung and Colon Cancer Assay, is powered by the Company’s proprietary SLIMamp® and PiVAT® technologies, and decentralizes the testing process, reducing diagnostic costs and improving access and efficiency of complex NGS testing for pathologists, prescribers, and patients worldwide. The Company has more than 20 NGS testing products available in IVD or RUO formats, and several others in various stages of development, including a pan-cancer oncoReveal™ CDx assay, and two liquid biopsy offerings. Pillar’s patented technologies have been shown to provide accurate and actionable data in as little as 48 hours, which allows physicians to select appropriate therapies and monitor the patient’s response. Pillar Biosciences has operations in Natick, MA and Shanghai, China. For more information, visit www.pillar-biosciences.com.

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