Invivoscribe® Releases LeukoStrat® CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit
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."
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.
- Papaemmanuil E, Gerstung M, Bullinger L, et al. N Engl J Med 2016;374(23):2209-2221
- Levis, M. Hematology Am Soc Hematol Educ Program 2013;2013:220-6
CONTACT: Kevin Dobyns 858-224-6600
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
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
Effnetplattformens intressebolag Earners Alliance genomför nyemission25.6.2018 10:00 | Pressmeddelande
Stockholm, 25 juni 2018 -- För att möjliggöra en internationell expansion genomför Earners Alliance Holding AB (publ), f.d. CasinoWilds Holding AB (publ), ("Earners Alliance") för närvarande en nyemission med företräde för sina befintliga aktieägare om cirka 10 MSEK före emissionskostnader. Teckningstiden pågår till och med den 6 juli 2018. Under 2019 planerar bolaget för en notering på Nasdaq First North, Nordic Growth Market eller Spotlight Stock Market. Emissionslikviden avses huvudsakligen att användas för försäljning och marknadsföring. Företrädesemissionen genomförs genom utgivande av teckningsrätter. Aktieägare erhåller en (1) teckningsrätt per befintlig aktie och erbjuds att för fem (5) teckningsrätter teckna två (2) nyemitterade aktier för 4,50 SEK per aktie. Anmälan av intresse om teckning av aktier utan stöd av företrädesrätt i företrädesemissionen sker genom att ifyllnad av särskild anmälningssedel. Effnetplattformen kommer att delta i nyemissionen. Mer information om Earne
ERYTECH Confirms Strategic Focus of Eryaspase on Solid Tumors and Ceases Development in Acute Lymphoblastic Leukemia25.6.2018 00:06 | Pressmeddelande
Conference call on Monday, June 25th at 2:30 pm CET/8:30 am EDT Focuses development efforts on solid tumor indications Confirms planned launch of company-sponsored randomized Phase 2 trial in first-line pancreatic cancer, in addition to ongoing launch of Phase 3 trial in second-line pancreatic cancer. Expands eryaspase production capacity in the United States and France Plans to cease development in acute lymphoblastic leukemia (ALL), including withdrawal of European Marketing Authorization Application (MAA) LYON, France and CAMBRIDGE Mass., June 24, 2018 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it will focus its development efforts for its product candidate eryaspase on the potential treatment of selected solid tumor indications. The company also announced that it plans to cease its development pro
CORRECTING and REPLACING -- PRESS ALERT & INVITATION: Arbitrade to Hold a Press Conference on June 28th From Bermuda - Its New Global Headquarters23.6.2018 14:00 | Pressmeddelande
NEW YORK, June 23, 2018 (GLOBE NEWSWIRE) -- In a press release issued under the same headline earlier today by Arbitrade, please note that the correct date of the event is Thursday, June 28, 2018 at 8:00 a.m. EDT. The corrected release follows: This is an invitation to all media following Arbitrade and/or covering the cryptocurrency markets. You are invited to join Arbitrade's Chairman, Len Schutzman, and management who will discuss their progress toward establishing Arbitrade as a world-class cryptocurrency exchange and coin company. They will also discuss their move and incorporation into Bermuda, one of the world's best regulated jurisdictions and a platform from which Arbitrade will reach out to several international markets. It will be a lively discussion that will also include details of the many economic and social advantages and new jobs that companies, like Arbitrade, will bring to countries in which they settle and do business around the world. Details of how to access the pr
15th Consecutive Nasdaq Closing Cross Sets Record for Number of Shares Traded During 2018 Russell US Indexes Reconstitution22.6.2018 23:19 | Pressmeddelande
NEW YORK, June 22, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) today announced the Nasdaq Closing Cross had a record day as it was used for the 15th consecutive year to rebalance Nasdaq-listed securities in the entire family of Russell U.S. Indexes, part of leading global index provider FTSE Russell, during their annual reconstitution. A record 1.188 billion shares representing $39.26 billion were executed in the Closing Cross in 0.935 seconds across some 2,591 Nasdaq-listed stocks. This compares to 2017, when Nasdaq executed 972 million shares representing $28.9 billion executed in 0.861 seconds across 2,499 Nasdaq-listed stocks. "Today, we saw a record-breaking performance for the Nasdaq Closing Cross, which benefits issuers and investors alike with transparent and efficient price discovery," said Tom Wittman, Head of Global Equities and Executive Vice President of Global Trading and Market Services at Nasdaq. "The rebalance is an important event to ensure that the Russell U.S. ind
PRESS ALERT & INVITATION: Arbitrade to Hold a Press Conference on June 28th From Bermuda - Its New Global Headquarters22.6.2018 22:29 | Pressmeddelande
NEW YORK, June 22, 2018 (GLOBE NEWSWIRE) -- This is an invitation to all media following Arbitrade and/or covering the cryptocurrency markets. You are invited to join Arbitrade's Chairman, Len Schutzman, and management who will discuss their progress toward establishing Arbitrade as a world-class cryptocurrency exchange and coin company. They will also discuss their move and incorporation into Bermuda, one of the world's best regulated jurisdictions and a platform from which Arbitrade will reach out to several international markets. It will be a lively discussion that will also include details of the many economic and social advantages and new jobs that companies, like Arbitrade, will bring to countries in which they settle and do business around the world. Details of how to access the press briefing webcast are as follows: Please register now for the upcoming Arbitrade Conference Call: Date: Wednesday, June 27, 2018 Time: 8:00 a.m. EST We recommend that you connect to the meeting at l
Northland Power's Hai Long Offshore Wind Project Awarded Additional 744 Megawatts in Taiwan Auction22.6.2018 14:15 | Pressmeddelande
TORONTO, June 22, 2018 (GLOBE NEWSWIRE) -- Northland Power Inc. ("Northland") (TSX:NPI) today announced that the Taiwan Bureau of Energy ("BOE") has awarded 232 megawatts ("MW") to the Hai Long 2 offshore wind farm ("Hai Long 2") and 512 MW to the Hai Long 3 offshore wind farm ("Hai Long 3") under Taiwan's offshore wind auction program. These awards are separate from and in addition to the 300 MW in 2024 that Hai Long 2 was allocated by the Taiwan BOE on April 30, 2018 under Taiwan's Feed-in-Tariff ("FIT") program. Northland and its partner Yushan Energy Co. Ltd. ("Yushan Energy") own 60% and 40%, respectively, of Hai Long 2 and Hai Long 3. This is another significant step for Northland in Taiwan, with a second and third project progressing to connect to Taiwan's grid in 2025, subject to securing 20-year power purchase agreements. Taken together with the FIT award, the Hai Long 2 and Hai Long 3 offshore wind farms now total 1,044 MW of offshore wind capacity in Taiwan. Northland is bui
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum