SAN DIEGO, May 21 (Korea Bizwire) — Invivoscribe, Inc., a vertically integrated global company focused on Improving Lives with Precision Diagnostics®, today announces expansion of space and testing capabilities in their international network of accredited LabPMM® clinical laboratories. Additions to the test menu will include morphology, IHC, flow cytometry, as well as the latest multiparameter flow- (MPF), and NGS-based minimal residual disease (MRD) testing of primary specimens. These new services will further support rapid patient diagnosis, study subject enrollment, and study subject stratifications. They will be available by end of this year in San Diego followed by the laboratories in Japan, Germany and China.
“Our comprehensive test menu will eliminate the need for partners to split primary specimens, dramatically decreasing turnaround times and accelerating receipt of comprehensive test reports. This is especially important for partners performing international clinical trials, as enrollment in frontline therapies often requires timely testing and reporting, which can be delayed when using multiple vendors,” said Dr. Jeffrey Miller, CSO & CEO.
“Rapid generation of test results improves enrollment rates, often an important barrier in completing clinical trials. Generation of internationally standardized test results mitigates risk by ensuring cohorts are homogeneous and arms are properly balanced. Reducing variables collapses timelines for regulatory submissions and accelerates approvals of novel new therapies. Patients in critical need of new therapies will ultimately be the big winners here,” he added.
“In addition, regulatory agencies and our partners are requesting a combination of MPF and NGS-based MRD testing; coherent comparison of these MRD test results can only happen if testing is done intramurally on the same specimens, drawn at the same time, using well validated standardized tests. Our tests and associated software are developed under design controls to meet relevant international regulatory requirements.”
Invivoscribe’s wholly-owned LabPMM laboratories are accredited per regional requirements (e.g. CAP, New York State-license, ISO 15189, RiliBÄK, Kawasaki City, etc.) and are the only clinical reference laboratories offering tests with bioinformatics software developed and manufactured by Invivoscribe in its FDA-registered cGMP facility.
Invivoscribe has acquired additional contiguous space for its accredited laboratories in San Diego, Japan, Germany, and China. Greater than 95% of patient samples tested using their FDA-approved LeukoStrat® CDx FLT3 Mutation Assay and selection of other CLIA-validated PCR-based capillary assays report out results within 48 hours of sample receipt at any of their LabPMM laboratories. A number of their NGS-based MRD assays, such as their LymphoTrack® assays, can achieve limits of detection of 10-6 for those requiring that level of sensitivity.
Invivoscribe is a privately held biotechnology company. Now in its twenty-fifth year of operation, Invivoscribe has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.
Source: Invivoscribe, Inc. via GLOBE NEWSWIRE