医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

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

2022年08月22日 PM08:00
このエントリーをはてなブックマークに追加


 

NATICK, Mass.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220822005134/en/

CONTACT

Investor Contact:

Dawn Schottlandt

Argot Partners

212-600-1902

Pillar@argotpartners.com

Media Contact:

Joshua R. Mansbach

Argot Partners

212-600-1902

Pillar@argotpartners.com

同じカテゴリーの記事 

  •  MedTech Innovator Asia Pacific Names APrevent Top 2024 Innovator in Grand Finals Competition
  • Novel Computational Pathology-Based TROP2 Biomarker for Datopotamab Deruxtecan Was Predictive of Clinical Outcomes in Patients with Non-Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial
  • Ivonescimab Monotherapy Reduced the Risk of Disease Progression or Death by 49% Compared to Pembrolizumab Monotherapy in First-Line Treatment of Patients with PD-L1 Positive Advanced NSCLC in China
  • Ifinatamab Deruxtecan Continues to Demonstrate Promising Objective Response Rates in Patients with Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial
  • Huonslab Announces Positive Results from In Vivo comparative PK study of Trastuzumab/HyDIFFUZETM compared with marketed rHuPH20 co-formulation with Trastuzumab