Invivoscribe Announces Key Submission in EU, Increased Presence and Activity in China | Business
SAN DIEGO – (BUSINESS WIRE) – July 22, 2021–
Invivoscribe, Inc., an industry pioneer in the development and commercialization of diagnostic products and reagents for hematologic malignancies, today announced a key submission in the EU, as well as a presence and activity increased in China.
Since May 26, 2022, IVDs in the EU must be certified in accordance with the new in vitro diagnostic (IVDR (2017/746)) before they are placed on the market. In addition, all IVDs on the market will have to be submitted to IVDR qualified notified bodies in Europe. As a leading diagnostic company, Invivoscribe, Inc. has demonstrated readiness through its early submission to BSI (The Netherlands) and has planned and prepared the ground for further IVDR submissions. In these rapidly changing times, Invivoscribe, Inc. is poised to remain one of the leading providers of precision oncology diagnostics in the EU and globally, as demonstrated by the June submission of the LeukoStrat ® CDx FLT3 BSI mutation test.
Tony Lialin, Business Director of Invivoscribe, said: “By being one of the first to submit, we are rapidly developing a relationship with our Notified Body and mastering the IVDR regulatory guidelines, which should expedite the submission of all of our tests. As the first player, the submission requirements were still being finalized by BSI alongside Invivoscribe generating the Class C Companion Diagnostic Submission Package, demonstrating our strength to pivot to meet changing regulatory requirements. He adds: “Our early submission and additional packages in preparation help ensure that there is no disruption in testing coverage for EU patient populations. “
The submission of Invivoscribe’s companion IVDR diagnostic is quickly moving forward with this same CDx in China. LeukoStrat ® CDx FLT3 The mutation test was used to select patients in a Phase III drug trial that resulted in NMPA / CDE conditional approval in February 2021 of the drug Astellas gilteritinib fumarate used to treat R / R FLT3 + Patients with AML. This test is currently being evaluated at 3 AAA hospitals and is currently available as a clinical research service at Invivoscribe’s Shanghai-based laboratory. Invivoscribe Diagnostic Technologies (Shanghai) Co., Ltd. recently expanded its presence as a China-based CRO by building a laboratory that offers molecular cytometry and flow testing services standardized with those available through the LabPMM network of clinical laboratories that have served our partners and clients in the United States , in the EU and in Japan for some time.
With internationally standardized kits and services, custom test development solutions, clinical trial management, regulatory expertise and most recently an expansion as a leader for IVDR submissions in the EU all By expanding capabilities in China, Invivoscribe is strategically positioned to provide full support to our partners.
The LeukoStrat CDx FLT3 The mutation test is a PCR-based test in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase (TKD) domain mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myeloid leukemia (AML).
Invivoscribe has been improving life with Precision Diagnostics ® for over twenty-five years, advancing the field of precision medicine by developing and selling standardized bioinformatics reagents, tests and tools to more than 700 customers in 160 countries. Invivoscribe is also having a significant impact on global health by working with pharmaceutical companies to accelerate approvals of new drugs and treatments by supporting international clinical trials, developing, commercializing companion diagnostics and providing expertise in regulatory and regulatory services. laboratory. With its proven ability to provide global access to distributable reagents, kits and controls, as well as clinical trial services through our international clinical laboratory subsidiaries (LabPMM), Invivoscribe has proven to be an ideal partner . For more information, please visit: www.invivoscribe.com or contact Invivoscribe at: [email protected]
See the source version on businesswire.com: https://www.businesswire.com/news/home/20210722005162/en/
CONTACT: Tony Lialin
KEYWORD: NORTH AMERICA UNITED STATES ASIA PACIFIC EUROPE CHINA CALIFORNIA
INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL DEVICES PHARMACEUTICAL HEALTH CLINICAL TRIALS
SOURCE: Invivoscribe, Inc.
Copyright Business Wire 2021.
PUB: 07/22/2021 13:17 / DISC: 07/22/2021 13:17
Copyright Business Wire 2021.