As a companion diagnostic (CDx) test, the in vitro diagnostics (IVD) assay is now commercially available in the US, China and Europe for the identification of metastatic colorectal cancer patients.
In these patients, the cancer tumours express wild-type KRAS status. They may benefit if treated with specific targeted therapies, for example Erbitux (cetuximab) or Vectibix (panitumumab).
Pillar Biosciences CEO Randy Pritchard said: “The oncoReveal Dx Colon Cancer Assay localises NGS testing and efficiently provides a highly accurate genetic profile of KRAS mutations in metastatic colorectal cancer patients.
“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 company’s first NMPA-approved diagnostic product, the oncoReveal Dx Colon Cancer Assay is a tissue-based, NGS test.
It generates data by using the company’s sensitive SLIMamp NGS testing technology.
This data optimises the selection of precision therapy for patients with cancer.
In April 2020, the oncoReveal Dx Lung & Colon Cancer Assay from Pillar Biosciences obtained CE-IVD certification in Europe.
Furthermore, in July, the US Food and Drug Administration (FDA) accepted the Premarket Approval (PMA) supplement application submitted by the company for review of its Pan-cancer oncoReveal CDx, developed for tumour profiling and therapy selection.