Next-generation sequencing (NGS) tests developer Pillar Biosciences has received approval from the China National Medical Products Administration (NMPA) for its oncoReveal Dx Colon Cancer Assay.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

“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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.