Invivoscribe® Receives FDA Approval for the LeukoStrat® CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt® and is the First Companion Diagnostic for AML
SAN DIEGO, April 28, 2017 (GLOBE NEWSWIRE) -- Invivoscribe® Technologies Inc., a global company with more than 20 years of experience providing clonality and biomarker test solutions for the fields of oncology, personalized molecular diagnostics® and personalized molecular medicine®, today announces the premarket approval of LeukoStrat® CDx FLT3 Mutation Assay. Due to current labeling for the FDA approved test, FLT3 mutation testing with LeukoStrat® CDx FLT3 Mutation Assay is exclusively performed by The Laboratory for Personalized Molecular Medicine, a subsidiary of Invivoscribe Technologies, Inc., which has gained FDA approval for its FLT3 test as a companion diagnostic for the Novartis drug Rydapt® in newly diagnosed FLT3+ AML.
Under terms of a previously announced agreement with Thermo Fisher, Invivoscribe will also seek FDA approval of the LeukoStrat® CDx FLT3 Mutation Assay that will allow the sale of kits to other laboratories. The Invivoscribe LeukoStrat® CDx FLT3 Mutation Assay is a signal ratio assay that identifies both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, and identifies even large ITD mutations, which are missed using many current NGS-based assays.
FLT3 somatic variants are among the most common driver mutations with the strongest effects on the overall survival in acute myeloid leukemia1 (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 26.6 percent five-year survival rate2. Invivoscribe, working under a companion diagnostic agreement with Novartis, developed this companion diagnostic for FLT3 successfully achieving FDA regulatory approval. The Invivoscribe LeukoStrat® CDx FLT3 Mutation Assay is the first companion diagnostic for AML.
"This test approval 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. "And, as has been previously noted by others3, there is a need for an internationally standardized FLT3 mutation assay and this companion diagnostic is a step toward fulfilling that need."
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 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. 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's clinical testing services, tests and reagents are currently being used in more than 650 clinical and research laboratories in 65 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 www.flt3cdx.com.
1. Papaemmanuil E, Gerstung M, Bullinger L, et al. N Engl J Med 2016;374(23):2209-2221
3. Levis, M. Hematology Am Soc Hematol Educ Program 2013;2013:220-6
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
Integrum uppmärsammas av Frankrikes president Emmanuel Macron och Stefan Löfven17.11.2017 19:02 | Pressmeddelande
PRESSINFORMATION 17 november 2017 Integrum blev vid fredagens EU-toppmöte i Göteborg som ett av få inbjudna att presentera bolagets tankestyrda proteser för Frankrikes president Emmanuel Macron och Stefan Löfven. Detta i samband med det strategiska partnerskap för innovation mellan Frankrike och Sverige som undertecknades vid mötet med mål att presentera konkreta framsteg inom två år. Integrum var utvalt som ett bra exempel på innovativt företag som utvecklar avancerade medicintekniska produkter där samspelet mellan människa och teknik skapar stort värde för användaren. Under mötet med president Emmanuel Macron och Stefan Löfven demonstrerades Integrums världsunika proteser som styrs med hjälp av tankekraft. Tekniken möjliggör att personer kan få en protes direkt kopplat till skelett, nerver och muskler utan att ha elektroder tillfälligt fästa utanpå huden. "Det är självklart mycket hedrande att I
CrownBio Launches an Innovative Grant Program to Fund Advancements in Preclinical Oncology Research17.11.2017 18:07 | Pressmeddelande
SANTA CLARA, Calif., Nov. 17, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announces the launch of a grant program supporting oncology research scientists which provides funding for projects that show promise for scientific advancement of Patient Derived Xenograft (PDX) technology. Research Grants up to $50,000 will be awarded to projects focused on accelerating the pace of preclinical innovation and novel PDX methodologies that improve clinical predictions with sound science. The program offers an opportunity for investigators to receive funding for projects that may not receive support through traditional funding channels. Submitted proposals will be reviewed and selected by CrownBio's Scientific Steering Committee with the goa
Barings Backs Sentinel Capital Partners in Acquisition of Nekoosa17.11.2017 17:00 | Pressmeddelande
CHARLOTTE, N.C., Nov. 17, 2017 (GLOBE NEWSWIRE) -- Barings, one of the world's leading asset management firms, announced today that it served as Lead Agent on a senior secured credit facility to support Sentinel Capital Partners in its acquisition of Nekoosa ("Nekoosa" or the "Company"). Headquartered in Nekoosa, Wisconsin, the Company is a leading manufacturer of specialty paper and film products used in the graphics and commercial print markets, including application and pressure-sensitive tapes, specialty synthetic papers, sheeted digital and offset grade carbonless paper, and extruded film products. Nekoosa serves a highly diverse base of more than 70,000 commercial print and graphics shops in 65 countries. Barings served as lead senior lender on the transaction, which included a senior term loan and a revolving credit facility. "Sentinel is pleased to have Barings' support on our investment in Nekoosa," said Scott Perry, a partner with Sentinel Capital Partner
At SC17, ExaScaler and PEZY Computing Unveil Gyoukou Supercomputer with a High Combined Green500/Top500 Ranking16.11.2017 23:29 | Pressmeddelande
ExaScaler and PEZY Computing Also Take Top Three Green500 Positions DENVER, Nov. 16, 2017 (GLOBE NEWSWIRE) -- At SC17, ExaScaler and PEZY Computing unveiled their Gyoukou supercomputer whose Green500 and Top500 rankings attest to a unique combination of high efficiency and computing power. The Gyoukou supercomputer is installed at the Yokohama Research Institute in Japan. (Video: PEZY Liquid immersion cooling) PEZY supercomputers leverage 48V Factorized Power, a high efficiency, high density power distribution architecture. PEZY's CPUs are co-packaged with Vicor's Power-on-Package ("PoP") Modular Current Multipliers ("MCMs"), which enable efficient, direct 48V to sub-1V current multiplication at the XPU. ExaScaler and PEZY Computing also achieved the #1, #2 and #3 positions on the Green500. These supercomputer system installations also utilize 48V Factorized Power. Come see us at SC17 at Booth 633 where ExaScaler / PEZY Computing will be
ELS Educational Services, Inc. Launches New Vacation English Program Starting January 201816.11.2017 20:59 | Pressmeddelande
New York, New York, Nov. 16, 2017 (GLOBE NEWSWIRE) -- ELS Educational Services, Inc. - one of the leading language services providers worldwide - has launched a new vacation English language program, ELS Language Experience+, which is set to begin enrollment for January 2018. "Here at ELS, our students and their English language goals always come first, and we are proud to introduce ELS Language Experience+ as an exciting new addition to the many quality programs we offer them," said ELS Chief Operating Officer, Reiji Terasaka. "This conversation-oriented, flexible new vacation English program allows students to make the most of their English instruction while gaining an invaluable cultural experience at the same time." ELS Language Experience+ concentrates on everyday speaking, communication skills and discussion, within a flexible course structure (three or six hours of study per day). Courses offered include: Everyday English, Grammar in Action, D
Global SD-WAN Partnership between CallTower and Aryaka to Deliver High-Performance Cloud Communication Solutions to Global Enterprises16.11.2017 16:02 | Pressmeddelande
SAN MATEO, Calif., Nov. 16, 2017 (GLOBE NEWSWIRE) -- Aryaka, the leading global SD-WAN provider, today announced a new partnership with CallTower, an industry-leading unified communications and collaboration company, to provide global enterprise customers with fast and reliable, high-quality cloud service connectivity. CallTower's partnership with Aryaka will deliver improved performance of their unified communications solutions to global enterprise customers. CallTower has linked their data centers with the Aryaka global network to deliver secure, reliable connectivity with quality of service guarantees for mission critical real-time communication applications. CallTower Cisco and Microsoft unified communications solutions, including Cloud Contact Center customers will now be able to add Aryaka's global SD-WAN service to further optimize, and enhance reliability over a secure network. "In addition to our unified communications offering, we have seen tremendous growth i
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum