Thermo Fisher Scientific’s Oncomine Dx Target Test received initial FDA approval as a CDx in 2017. Credit: larsjuh / Flickr.

Thermo Fisher Scientific has obtained premarket approval from the US Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic (CDx) for Takeda’s drug for non-small cell lung cancer (NSCLC) patients.

Oncomine Dx Target Test is intended to identify patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic NSCLC (mNSCLC) who are candidates for Takeda’s Exkivity (mobocertinib).

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It can assess 23 genes linked to NSCLC at once.

The test was initially approved by the FDA as a CDx in 2017 and is currently approved for five targeted treatments for NSCLC and one targeted therapy for cholangiocarcinoma in the US.

Furthermore, Oncomine Dx Target Test is cleared by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a CDx for five biomarkers, namely, EGFR; ALK; ROS1; BRAF and RET, which are linked to ten targeted NSCLC treatments.

At present, the test is approved and reimbursed by the government, as well as commercial insurers, in more than 15 countries, including the US, various European nations, Japan, South Korea and the Middle East.

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Standard polymerase chain reaction methods can miss half or more of EGFR Exon20 insertion mutations, encouraging diagnostic molecular testing with next-generation sequencing (NGS) technology.

Testing with NGS is vital for early detection and suitable characterisation of tested patients, the company noted.

Thermo Fisher Scientific clinical next-generation sequencing and oncology president Garret Hampton said: “Exkivity offers new hope to previously treated patients with mNSCLC and EGFR Exon20 insertion mutations, who usually do not respond well to other available treatments.

“FDA approval of the Oncomine Dx Target Test as a companion diagnostic for Exkivity will allow clinicians to identify key biomarkers in patients who could benefit from this targeted therapy.

“Working closely with Takeda to scale the clinical adoption of the test as a companion diagnostic for Exkivity is an important next step to enabling precision medicine and potentially improving outcomes of lung cancer patients.”

A small-molecule tyrosine kinase inhibitor (TKI), Exkivity is created to specifically target EGFR Exon20 insertion mutations.

The FDA-approved drug is indicated to treat adult patients with locally advanced or mNSCLC with EGFR Exon20 insertion mutations, as identified by an FDA-cleared test, whose disease has advanced while on or after platinum-based chemotherapy.