NGS-based CDx Human NTRK1 / 2/3 Genomic Alteration Test Kit to Inform Treatment Decisions for Larotrectinib Developed by OrigiMed in Cooperation with Bayer Received NMPA’s Special Review Procedure for Innovative Medical Devices in China
Companion Diagnosis (CDx) Human Neurotrophic Tyrosine Receptor Kinase (NTRK) 1/2/3 The genomic alteration test kit developed by OrigiMed in cooperation with Bayer benefits from the special examination 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 a NTRK gene fusion, is approved in more than 40 countries, including United States (United States), European Union (EU) countries and Japan for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion and is under development in China.
SHANGHAI, August 21, 2021 / PRNewswire / – OrigiMed announced that the Human NTRK1/2/3 The Genomic Alteration Test Kit has received the Special Review Procedure for Innovative Medical Devices by the Center for Medical Device Evaluation of the NMPA. This test kit is developed by OrigiMed in cooperation with Bayer.
Human NTRKThe 1/2/3 Genomic Alteration Test Kit is developed to detect NTRK 1, 2 and 3 gene fusions in solid tumors. This 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 a NTRK gene fusion, is approved in more than 40 countries, including the US, EU countries and Japan for adult and pediatric patients with solid tumors that harbor a NTRK gene fusion. Additional deposits in other markets including China, are in progress or planned.
The NTRK 1/2/3 Human Genomic Alteration Test Kit is based on DNA and RNA-based Next Generation Sequencing (NGS) and applies the innovative OriFusion technology independently patented by OrigiMed as the core technology. Candidates for fusion are identified by technology based on hybrid capture. Besides the known fusion, it can also efficiently detect new fusions with high sensitivity and specificity.
Larotrectinib, a highly selective TRK inhibitor, has been exclusively designed to treat tumors that are NTRK1/2/3 positive fusion gene (TRK fusion cancer). The compound has been shown to have high response rates and lasting responses over three years in adults and children with TRK fusion cancer, including responses and a high rate of disease control in tumors of the nervous system central (SNC). It has the largest data set and the longest follow-up data of any TRK inhibitor. The 218 patient data set was presented at the ASCO 2021 annual meeting.
Larotrectinib is approved under the brand name Vitrakvi ™ in more than 40 countries, including the US, EU countries, Japan and other markets around the world, for pediatric and adult patients with solid tumors that harbor a NTRK gene fusion. Additional deposits in other markets including China, are in progress or planned. Human NTRK1/2/3 Genomic Alteration Detection Kit is a companion diagnostic test for larotrectinib in the treatment of adult and pediatric patients in China with solid tumors that harbor a NTRK gene fusion once larotrectinib has been approved for medical use.
About TRK Fusion Cancer
TRK fusion cancer is rare overall, affecting both children and adults, and occurs at varying frequencies with different 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 engines that fuel the spread and growth of cancer in patients, regardless of its origin in the body.
OrigiMed is a high-tech R&D focused precision medicine company with a global vision and knowledge transfer in clinical cancer practice. With the commitment to develop hundreds of genomic cancer tests, the company strives to provide complete and accurate molecular information to each patient and to assist physicians in their practice of precision medicine. OrigiMed aims to promote innovation in the clinical treatment of cancer in China. At OrigiMed, patients’ molecular changes are identified by rigorously verified CGP and matched with targeted therapies, immunotherapies and approved clinical trials. OrigiMed works closely with global and national biopharmaceutical companies to assist in the development and approval of new drugs. For more information, please visit: www.origimed.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/the-ngs-based-cdx-human-ntrk123-genomic-alteration-test-kit-to-inform-treatment-decisions -for -larotrectinib-developed-by-origimed-in-cooperation-with-bayer-has-obtained-the-nmpa-special-examination-procedure-for-innovative-medical-dev-301359690.html