NEW YORK – Pillar Biosciences said Monday that China's National Medical Products Administration has granted commercial approval for its OncoReveal Dx Colon Cancer Assay.
The next-generation sequencing, tissue-based companion diagnostic uses Pillar's amplicon-based target enrichment technology to identify metastatic colon cancer patients with KRAS wild-type tumor status, who might benefit from approved therapies such as Eli Lilly's Erbitux (cetuximab) or Amgen's Vectibix (panitumumab).
Pillar previously received CE-IVD certification in Europe and premarket approval from the US Food and Drug Administration for its OncoReveal Dx Lung and Colon Cancer Assay.
"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," Pillar CEO Randy Pritchard said in a statement. "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."
Earlier this year, the Natick, Massachusetts-based company also received CLIA certification for its clinical sequencing lab, enabling it to support preclinical and clinical studies.