The NGS-based 8-gene lung cancer assay is said to be the first approved NGS-based panel for non-small cell lung cancer (NSCLC)
Genetron Health and HUTCHMED have collaborated to develop CDx test for Orpathys. (Credit: Michal Jarmoluk from Pixabay)
Genetron Holdings has entered into a collaboration agreement with HUTCHMED (China) to develop a companion diagnostic (CDx) test for Orpathys (savolitinib) in China.
As part of the deal, the companies will jointly validate and register Genetron Health’s approved NGS-based 8-gene lung cancer assay (tissue) as CDx for Orpathys.
Orpathys is an oral, potent and highly selective MET tyrosine kinase inhibitor (TKI), which has shown clinical activity in advanced solid tumours, said the company.
The NGS-based 8-gene lung cancer assay, which is based on Genetron Health’s One-step Seq method, secured approval from the China’s National Medical Products Administration (“NMPA”) as an IVD assay last year.
HUTCHMED executive director and chief scientific officer Dr Weiguo Su said: “CDx test is becoming a valuable tool for the use of Orpathys in the clinical setting for NSCLC patients harboring MET exon 14 skipping alterations.”
The NGS-based 8-gene lung cancer assay is said to be the first approved NGS-based panel for non-small cell lung cancer (NSCLC), which holds the potential to identify RNA-based MET exon 14 skipping alterations for therapy selection and monitoring.
The assay also secured CE mark approval last year, as well as coomercialised in China for use in hospitals.
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 companion diagnostics 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.”
In June 2020, precision oncology platform firm Genetron Health secured emergency use authorisation (EUA) from the FDA for its independently developed detection kit for the novel coronavirus.