GlobeNewswire

Invivoscribe® Releases LeukoStrat® CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit

Del

SAN DIEGO, Aug. 01, 2017 (GLOBE NEWSWIRE) -- Invivoscribe® Technologies Inc., a global company with decades of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular medicine®, today announces the release of the CE-marked IVD version of its LeukoStrat® CDx FLT3 Mutation Assay which earlier this year was approved by the FDA1.

The assay identifies both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, and identifies even large ITD mutations, missed using many current NGS-based assays. The kit includes CE-marked software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to midostaurin.

Invivoscribe will also seek FDA approval of the LeukoStrat® CDx FLT3 Mutation Assay to allow the sale of kits to laboratories in the United States.

The Invivoscribe LeukoStrat® CDx FLT3 Mutation Assay is the first companion diagnostic for AML, and the only commercially available signal ratio assay validated in international clinical trials so the results generated are harmonized for healthcare providers worldwide. It is currently being utilized for enrollment in multiple international clinical trials.

Mutations in FLT3 are among the most common driver mutations, with the strongest effects on the overall survival in acute myeloid leukemia2 (AML), the most deadly form of leukemia, which is diagnosed in about 20,000 new patients each year in the U.S. and has only a 26.9 percent five-year survival rate3.

"Release of this CE-marked IVD signal ratio assay will be of substantial benefit to patients afflicted with AML and is a critical tool for healthcare providers to identify the most appropriate treatment for newly diagnosed FLT3-mutated AML patients, furthering the promise of personalized molecular diagnostics and precision medicine," said Dr. Jeffrey Miller, CSO & CEO of Invivoscribe. "Further, as has been noted by others4, there is a need for an internationally standardized FLT3 mutation assay and release of this product helps fulfill that need."

About Invivoscribe 
Invivoscribe provides ISO 13485 certified, PCR- and NGS-based reagents manufactured in a facility registered with FDA; RUO test kits; CE-marked IVDs, including IdentiClone® and LymphoTrack® Dx Assays with both LymphoTrack® and LymphoTrack® Dx Software; for clonality, MRD, and somatic hypermutation testing. Invivoscribe also offers comprehensive MyAML®, MyHeme®, MyMRD®, and custom gene panels, that when used in combination with Invivoscribe's proprietary MyInformatics®Software can identify and 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's tests, reagents and bioinformatics tools are currently being used in more than 700 clinical and research laboratories in more than 102 countries. Invivoscribe has long embraced the value of quality systems and develops all products, including bioinformatics software, compliant with ISO 13485 design control, making them eligible to be brought through regulatory process to authorities worldwide.  Additional information can be found at www.invivoscribe.com and ce.flt3cdx.com.

References:

  1. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm555778.htm
  2. Papaemmanuil E, Gerstung M, Bullinger L, et al.  N Engl J Med 2016;374(23):2209-2221
  3. https://seer.cancer.gov/statfacts/html/amyl.html
  4. Levis, M. Hematology Am Soc Hematol Educ Program 2013;2013:220-6
CONTACT:
Kevin Dobyns 858-224-6600



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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

Om GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra GlobeNewswire

Compuware Announces Day One Support for IBM CICS Transaction Server for z/OS V5.514.12.2018 18:02Pressemelding

DETROIT, Dec. 14, 2018 (GLOBE NEWSWIRE) -- Compuware Corporation, the world’s leading mainframe-dedicated software company, is pleased to announce Day One support for IBM CICS Transaction Server (TS) for z/OS V5.5. Compuware worked in collaboration with IBM to ensure that its solutions—including Abend-AID, File-AID, Strobe, Topaz and Xpediter—work seamlessly for z/OS customers installing or upgrading to this newest version of CICS TS. New capabilities within CICS TS V5.5 include support for JavaScript Node.js applications; an enhanced CICS Explorer; as well as advancements in systems management and enhanced security. “Compuware has an extensive history of ensuring our products work seamlessly with IBM releases and the release of CICS Transaction Server V5.5 is no exception,” said Sam Knutson, Vice President of Product Management for Compuware. “Our solutions excel at helping enterprises include the mainframe in their cross-platform Agile DevOps practices and processes so they can succe

SoftServe Achieves Machine Learning Specialization in Google Cloud Partner Program14.12.2018 13:00Pressemelding

Google Cloud recognizes SoftServe’s technical proficiency and proven success AUSTIN, Texas, Dec. 14, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, announces it achieved the Machine Learning Partner Specialization in the Google Cloud Premier Partner Program. The Partner Specialization affirms SoftServe’s expertise and success building customer solutions in the machine learning field using Google Cloud Platform (GCP) technology. The Google Cloud Partner Specialization Program is designed to provide Google Cloud customers with qualified partners that demonstrate technical proficiency in the specialized solution and service areas. Specifically, the Machine Learning Specialization demonstrates SoftServe’s expertise in data exploration, preprocessing, model training, model evaluation, model deployment, online prediction, and Google Cloud’s pre-trained machine learning APIs. “We teach machines to learn, read, see and understand business data, and make

Minerals Technologies Announces Price Increases for Specialty Minerals Products in Europe14.12.2018 00:01Pressemelding

NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Specialty Minerals Inc. (“SMI”), a subsidiary of Minerals Technologies Inc., announced today that effective February 1, 2019, it will increase prices by up to 10% for all coated ultrafine precipitated calcium carbonate (PCC) from SMI’s Lifford Specialty PCC facility in Birmingham, UK, subject to individual customer contracts and market provisions. The price increases reflect increased market demand for higher performance materials, as well as significant inflation in input, raw material and logistics costs. About Minerals Technologies Inc. New York-based Minerals Technologies Inc. (MTI) is a resource- and technology-based growth company that develops, produces and markets worldwide a broad range of specialty mineral, mineral-based and synthetic mineral products and related systems and services. MTI serves the paper, foundry, steel, construction, environmental, energy, polymer and consumer products industries. The Company reported sales of $1.

Synthesio to Bring Proven Ipsos Data Science to Artificial Intelligence13.12.2018 17:03Pressemelding

Synthesio's Next-Generation Social Media Intelligence to Raise Unseen Insights to the Surface, Faster NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Synthesio, an Ipsos company, and also the leading Social Media Intelligence Suite, today announced the plans for its next-generation Artificial Intelligence (AI) engine. The project will combine Synthesio’s AI technology with Ipsos’ data science. The combination will power upcoming Synthesio capabilities to help users find insights faster, remove guesswork, and make informed business decisions across a variety of use cases. “Our goal has always been to provide customers with meaningful data, visualized so that they can make strategic business decisions,” explained Loic Moisand, CEO & Founder of Synthesio. “The less guesswork that a company has to make, and the less time that it takes users to find meaningful insights, the more time for data-backed business decisions. We are really pleased that we can leverage the data science capabilities dev

XBiotech Announces Publication of Post-Hoc Analysis for Phase III Colorectal Cancer Study13.12.2018 14:00Pressemelding

Biomarkers Predict Significantly Higher Rates of Treatment Response to Bermekimab in Advanced Cancer Patients AUSTIN, Texas, Dec. 13, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today the publication of findings on key biomarker analysis of colorectal cancer patients treated with bermekimab in its European Phase III study. The manuscript, entitled, “Interleukin-1 Receptor Antagonist (IL-1ra) Levels Predict Favorable Outcome after Bermekimab, a First-in-Class True Human Interleukin-1α Antibody, in a Phase III Randomized Study of Advanced Colorectal Cancer”, has been published online in the journal OncoImmunology. The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—which tend to worsen with advanced cancer, to assess whether these sympto

FROM CUTE TO CONFIDENT: MARY KAY INC. TALKS PINK AT THE MUSEUM AT FIT13.12.2018 14:00Pressemelding

Mary Kay Inc. and The Museum at The Fashion Institute of Technology Partner for a Pink-Centric Panel Discussion in Conjunction with Special Exhibition ‘Pink: The History of a Punk, Pretty, Powerful Color’ NEW YORK, N.Y., Dec. 13, 2018 (GLOBE NEWSWIRE) -- From pink makeup compacts to the iconic pink Cadillac, global beauty brand Mary Kay has been synonymous with the color pink for more than five decades. On December 13, 2018, Mary Kay will partner with The Museum at FIT (MFIT) to host a scholarly panel discussion, ‘Powerful Pink: From Cute to Confident,’ at the Katie Murphy Amphitheatre on the New York City FIT campus. Panelists include Luis Casco, Mary Kay Global Beauty Ambassador and celebrity makeup artist; Kate Greene, Vice President of Communications and Creative Direction at Givaudan and Karen Young, FIT adjunct professor and founder of The Young Group. The panel discussion will be moderated by Sheryl Adkins-Green, Chief Marketing Officer for Mary Kay Inc. The scholarly panel disc