Genetron Health and Hutchmed (China) have signed a collaboration agreement to develop a companion diagnostic (CDx) test for Orpathys (savolitinib) in the country.
Under the terms of the deal, the companies will jointly authorise and register Genetron Health’s eight-gene lung cancer assay (Tissue) as a CDx for Orpathys, an oral, potent, and MET tyrosine kinase inhibitor (TKI).
Genetron’s assay covers the HER2, BRAF, PIK3CA, EGFR and KRAS mutations; translocations of ALK and ROS1; and MET exon 14 skipping.
The 2018 National Comprehensive Cancer Network guidelines recommended seven of these genes as biomarkers for non-small cell lung cancer (NSCLC) patients.
The next-generation sequencing (NGS)-based assay, developed using Genetron’s One-step Seq method, was approved as an in vitro diagnostic (IVD) assay by National Medical Products Administration in China in 2020.
It is claimed to be the first approved test for NSCLC that can detect RNA-based MET exon 14 skipping alterations for therapy selection and monitoring.
Last year, the test obtained the CE mark and has been commercialised for use in Chinese hospitals.
Orpathys blocks atypical activation of the MET receptor tyrosine kinase pathway which occurs due to gene amplification or mutations.
It is being sold in China to treat NSCLC patients with MET exon 14 skipping alterations who have progressed after systemic therapy or are unable to receive chemotherapy.
Genetron Health co-founder and CEO Sizhen Wang said: “Orpathys represents another important treatment option for NSCLC patients in China, and we are very excited to partner with HUTCHMED to further develop our Lung 8 assay as their first RNA-based NGS CDx product for this novel drug.
“This partnership represents another major CDx partnership for us and upon approval, we expect this to further increase Lung 8’s penetration into China’s top hospitals.
“As precision medicine and targeted therapeutics continue to gain traction in China, we continue to expect CDx development to follow suit.”
Last October, Genetron Health and Shanghai Fosun Pharmaceutical’s (Fosun Pharma) subsidiary Jiangsu Fosun Pharmaceutical signed an exclusive agreement to commercialise the Seq-MRD molecular diagnostic assay in China.