The approval allows to use the Oncomine Dx Target Test to detect NSCLC patients whose tumors carry EGFR Exon20-insertion mutations for treatment with Janssen’s Rybrevant
Oncomine Dx Target Test now approved for 12 NSCLC targeted therapies across the globe. (Credit: Thermo Fisher Scientific Inc)
Thermo Fisher Scientific has secured approval from the US FDA for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify lung cancer patients for treatment with Janssen’s drug.
The approval allows to use the next-generation sequencing (NGS) based CDx to detect non-small cell lung cancer (NSCLC) patients whose tumours carry EGFR Exon20-insertion mutations for treatment with Janssen Biotech’s targeted therapy Rybrevant (amivantamab-vmjw).
For the second time, Oncomine Dx Target Test is approved as a CDx for EGFR Exon20 insertion mutant patients.
The test is now approved for 12 NSCLC targeted therapies across the globe, stated the company.
Thermo Fisher Scientific clinical next-generation sequencing and oncology president Garret Hampton said: “The FDA’s approval of Oncomine Dx Target Test enables clinicians to use FFPE tissue samples to identify patients in the U.S. who may benefit from this important new therapy.
“In situations where conventional testing may miss key mutations that could match patients with targeted therapies, NGS technology is vital to make these connections and advance precision medicine.
“We look forward to expanding registration of the test as a companion diagnostic for RYBREVANT globally to help improve outcomes for more patients.”
Oncomine Dx Target Test is claimed to be the first and only FDA-approved NGS CDx on formalin-fixed and paraffin-embedded (FFPE) tissue to determine Rybrevant eligibility in patients whose disease has progressed on or after platinum-based chemotherapy.
The Oncomine Dx Target Test, which is first approved by FDA as a CDx in 2017, holds the capacity to assess 23 genes associated with NSCLC.
In the US, the test is currently approved for six targeted therapies for NSCLC, including one for cholangiocarcinoma.
In addition, the test secured Japanese approval for five biomarkers, including EGFR, ALK, ROS1, BRAF, and RET, associated with 10 targeted therapies for NSCLC.
The NGS-based CDx is approved and reimbursed by government and commercial insurers in over 15 countries, including the US, multiple European countries, Japan, South Korea and the Middle East.