The Ministry of Health, Labour and Welfare (MHLW) of Japan has approved Amoy Diagnostics’ (AmoyDx) lung cancer testing panel as a companion diagnostic (CDx) for Tepmetko (tepotinib) of Merck KGaA, Darmstadt, Germany.
Leveraging polymerase chain reaction (PCR) technology, the AmoyDx Pan Lung Cancer PCR Panel (AmoyDx PLC Panel) can assess the presence of 11 driver genes at the same time.
The genes included in the panel are EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2 and NTRK3.
The AmoyDx PLC Panel obtained approval for five driver genes, EGFR, ALK, ROS1, BRAF and MET exon 14 skipping, for ten related targeted treatments for non-small cell lung cancer (NSCLC).
Furthermore, the panel has increased sensitivity and a rapid turnaround time, which will help it become a key clinical diagnostic in aiding treatment opportunities for patients with NSCLC.
Amoy Diagnostics founder and CEO Li-Mou Zheng said: “The approval of the AmoyDx PLC Panel marks the time that Japanese patients will have direct access to a locally administered multi-gene PCR CDx with a very short turnaround time from sample to diagnosis.
“Our goal at AmoyDx has always been to develop the highest regulatory-grade cancer diagnostics which have the greatest impact in a clinical setting.”
Japanese MHLW approved Tepmetko in March last year for the treatment of unresectable, advanced or recurrent NSCLC patients having MET gene exon 14 skipping alterations.
AmoyDx has partnered with domestic companies, namely Riken Genesis and Precision Medicine Asia (PREMIA), to make the panel available for Japanese patients.
PREMIA president and founder Wenn Sun said: “Both AmoyDx and Riken Genesis have been our long term partners, previously collaborating on the approval of the single ROS1 CDx for Xalkori in Japan.
“It is extremely gratifying to have this opportunity to collaborate again on this fit-for-purpose test that offers an accurate and timely diagnosis of actionable genetic alterations and designed to lead to better treatment options for patients.”
In 2016, Merck entered an agreement with AmoyDx to develop and commercialise the ADx-SuperARMS liquid biopsy RAS test for metastatic colorectal cancer (mCRC).