Share
FoundationOne Liquid CDx is a blood-based comprehensive genomic profiling test. Credit: PublicDomainPictures from Pixabay.

The US Food and Drug Administration (FDA) has granted approval for Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic for Takeda’s Exkivity (mobocertinib).

Exkivity already secured approval from the FDA for locally advanced or metastatic non-small cell lung cancer adult patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

FoundationOne Liquid CDx is claimed to be the only blood-based comprehensive genomic profiling test that received the US regulator’s approval for detecting EGFR exon 20 insertion mutations to identify suitable patients to treat with Exkivity.

This qualitative next-generation sequencing-based in vitro diagnostic test has the ability to analyse over 300 cancer-related genes for genomic alteration from a simple blood sample.

It specifically analyses 324 genes by deploying circulating cell-free DNA.

See Also:

The prescription use-only test received FDA approval to report short variants in 311 genes, as well as a companion diagnostic to detect patients who are expected to benefit from treatment with specific therapies.

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.

Foundation Medicine chief medical officer Mia Levy said: “Cancer is an incredibly complex disease, so it’s critical that oncologists leverage companion diagnostics, which are high-quality, well-validated genomic tests to inform treatment decisions for their patients.

“We’re proud of the work we’ve done with Takeda to develop blood and tissue-based companion diagnostics for therapies in their precision oncology pipeline, including this recent approval for Exkivity.”