The companion diagnostic (CDx) Human Neurotrophic Tyrosine Receptor Kinase (NTRK) 1/2/3 Genomic Alteration Testing Kit developed by OrigiMed in cooperation with Bayer is granted the Special Review Procedure for Innovative Medical Devices by the National Medical Products Administration (NMPA) of China.
The CDx test detects NTRK gene fusions via DNA- and RNA-based next-generation sequencing (NGS) to inform treatment decisions for larotrectinib.
Larotrectinib, a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, is approved in more than 40 countries including the United States (U.S.), countries of the European Union (EU), and Japan for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion and is in development in China.
SHANGHAI, Aug. 22, 2021 /PRNewswire/ -- OrigiMed announced that the Human NTRK1/2/3 Genomic Alteration Testing Kit has been granted the Special Review Procedure for Innovative Medical Devices by the Center for Medical Device Evaluation of NMPA. This testing kit is developed by OrigiMed in cooperation with Bayer.
The Human NTRK1/2/3 Genomic Alteration Testing Kit is developed to detect NTRK 1, 2 and 3 gene fusions in solid tumors. It is the first companion diagnostic specifically developed for larotrectinib in China and will help identify NTRK gene fusion-positive patients for whom treatment with larotrectinib may be appropriate.
Larotrectinib, a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, is approved in more than 40 countries including the U.S., countries of the EU, and Japan for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion. Additional filings in other markets, including China, are underway or planned.
The Human NTRK 1/2/3 Genomic Alteration Testing Kit is based on DNA- and RNA-based next-generation sequencing (NGS) and applies the innovative OriFusion independently patented by OrigiMed as its core technology. Fusion candidates are identified by hybrid-capture based technology. Besides the known fusion, it also can effectively detect novel fusions with high sensitivity and specificity.
Larotrectinib, a highly selective TRK inhibitor, was exclusively designed to treat tumors that are NTRK1/2/3 gene fusion positive (TRK fusion cancer). The compound has demonstrated high response rates and durable responses over three years in adults and children with TRK fusion cancer, including responses and a high disease control rate in central nervous system (CNS) tumors. It has the largest dataset and longest follow-up data of any TRK inhibitor. The dataset of 218 patients was presented at the ASCO Annual Meeting 2021.
Larotrectinib is approved under the brand name Vitrakvi™ in more than 40 countries, including the U.S., countries of the EU, Japan, and other markets around the world, for pediatric and adult patients solid tumors that harbor an NTRK gene fusion. Additional filings in other markets, including China, are underway or planned. The Human NTRK1/2/3 Genomic Alteration Detection Kit is a companion diagnostic test for larotrectinib in treating adult and pediatric patients in China with solid tumors that harbor an NTRK gene fusion once larotrectinib is approved for medical use.
About TRK fusion cancer
TRK fusion cancer is rare overall, affecting both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients' cancer, regardless of where it originates in the body.
OrigiMed is a precision medicine company focusing on high-tech R&D with a global vision and the knowledge transfer in the clinical practice of cancers. With the commitment to developing hundreds of cancer genomic tests, the company strive to provide comprehensive and accurate molecular information to every patient and help doctors with their precision medicine practice. OrigiMed aims to promote the innovation in the way of clinical treatment for cancer in China. At OrigiMed, patients' molecular changes are identified by the stringently verified CGP and matched with approved targeted therapies, immunotherapies, and clinical trials. OrigiMed closely collaborates with global and domestic biopharmaceutical companies to help with new drug development and approvals.