Thermo Fisher Scientific has secured approval from the US Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify non-small cell lung cancer (NSCLC) patients for treatment with Enhertu (fam-trastuzumab deruxtecan-nxki).
The regulatory approval enables the use of the next-generation sequencing (NGS)-based CDx in detecting NSCLC patients whose tumours have HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion).
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Notably, this is the eighth time that the Oncomine Dx Target Test has been approved as a CDx therapy selection indication.
The Oncomine Dx Target Test received its first FDA approval as a CDx in 2017, and it is currently approved for seven targeted therapies for NSCLC and one for cholangiocarcinoma in the US alone.
The Oncomine Dx Target Test is also claimed to be the only distributed NGS CDx that has received this regulatory approval.
It is now available in 17 countries for 15 targeted treatments, covering more than 550 million lives across the world.
The test has been designed to simultaneously assess 23 genes associated with NSCLC.
Thermo Fisher Scientific clinical NGS and oncology president Garret Hampton said: “With care decisions increasingly made based on a tumour’s molecular profile, the FDA’s latest approval of Enhertu in HER2 mutant metastatic non-small cell lung cancer and the additional approval of the Oncomine Dx Target Test as a companion diagnostic marks a significant step forward for precision oncology.
“To ensure patients and clinicians can readily access testing to inform care decisions, we are committed to making NGS accessible and easy to use so patients everywhere will be able to benefit from precision therapies, when indicated.”
Being jointly developed and marketed by Daiichi Sankyo and AstraZeneca, Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC).
Last month, Thermo Fisher Scientific reported revenues of $10.97bn in the second quarter of the year, representing an 18% increase from $9.27bn in the same quarter last year.
