Invivoscribe Expands Business into Solid Tumors with Assays and Services to Identify and Monitor CAR-T and TCR Immuno-Therapies - Seite 2
About Invivoscribe
Invivoscribe® Technologies Inc. is a privately held biotechnology company dedicated to improving the quality of
healthcare worldwide by providing high quality, reliable, cutting-edge reagents, tests, and bioinformatics tools to advance the fields of personalized molecular diagnostics® and personalized molecular medicine®. Invivoscribe is ISO
13485 certified and provides PCR- and NGS-based reagents manufactured in a facility registered with FDA. Reagents include RUO test kits and CE-marked IVDs, including IdentiClone® and LymphoTrack® Dx Assays with
LymphoTrack® Dx Software. LymphoTrack Dx Assays are CE-IVDs for clonality and IGHV somatic hypermutation testing and are not available for sale or use in North America. LymphoTrack Assays and MRD and immuno-therapeutic applications are for research use
only. Not for use in diagnostic procedures - US validations are on-going. Invivoscribe also offers comprehensive MyAML®,
MyHEME®, MyMRD®, and custom gene panel
services. Used in combination with Invivoscribe's proprietary MyInformatics® Software these assays identify and can
track primary driver mutations as well as the subclonal architecture and emergence of new driver mutations in patients with hematologic disease. Invivoscribe's clinical laboratories in the USA,
Europe, and Japan provide international access to harmonized CLIA, CAP, and ISO 15189 accredited clinical testing and contract research organization (CRO) services. Invivoscribe services and
reagents are currently used in more than 650 clinical and research laboratories in 65 countries and Invivoscribe has long embraced the value of quality systems and develops all products, including
bioinformatics software, compliant with ISO 13485 design control. This model makes the assays eligible to be brought through regulatory authorities worldwide. The company currently has on-going
companion diagnostic partnerships with Novartis and Astellas Pharma, Inc. and expects to announce additional collaborations in 2017. Additional information can be found at www.invivoscribe.com.
CONTACT: Kevin Dobyns 858-224-6600
Lesen Sie auch
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Invivoscribe, Inc. via Globenewswire