Invivoscribe® Releases LeukoStrat® CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit
1.8.2017 12:00 | NASDAQ OMX
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
Om NASDAQ OMX
NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra NASDAQ OMX
Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra NASDAQ OMX
Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40 | Pressemelding
Complementary core strengths provide broader range of services for customers KENNESAW, GA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Brand Industrial Services, known as BrandSafway, has signed an agreement to acquire Venko Groep BV, a portfolio company of Mentha Capital. Venko will become a part of the Brand Energy & Infrastructure Services (Brand) group. "We are very pleased to announce the agreement with Venko," said Bill Hayes, President and CEO of BrandSafway. "Our combined customers in Europe will benefit from a broader range of solutions and greater depth of expertise in access, insulation and coatings. Bringing Venko's highly specialized knowledge in coatings to BrandSafway will provide the expertise we need to expand our services in the offshore market worldwide." Based in the Netherlands, with a focus on operations in the North Sea area, Venko is a leading offshore and onshore coatings maintenance provid
Abeona Therapeutics Announces Pivotal Expansion of ABO-102 Gene Therapy Clinical Trials in Sanfilippo Syndrome Type A16.8.2017 15:38 | Pressemelding
NEW YORK and CLEVELAND, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, today announced the pivotal expansion of its gene therapy clinical trials for patients with MPS IIIA in the USA, Europe and Australia. "We have completed the necessary regulatory and ethical committee approvals and site initiations in Europe and Australia in order to accelerate enrollment," stated Juan Ruiz, M.D., Ph.D., Abeona's Chief Medical Officer. "We remain very encouraged by the improvements observed in clinically relevant biomarkers post-dosing of ABO-102, including durable reductions in heparan sulfate measured in the CNS, reduction of organ disease pathology, and signals of CNS improvement or stabilization at one-year follow-up in Cohort 1 subjects, and look forward to providing a more fulsome clinical update at important clinical
CallidusCloud Wins Eight Gold Stevies® in the 2017 International Business Awards16.8.2017 14:00 | Pressemelding
CallidusCloud Lead to Money suite recognized as Best B2B New Product of the Year. LeadRocket voted Best New Product or Service of the Year in the Software - Lead Generation Solution category. DUBLIN, Calif., Aug. 16, 2017 (GLOBE NEWSWIRE) -- Callidus Software Inc. (NASDAQ:CALD), a global leader in cloud-based sales, marketing, learning, and customer experience solutions, announced today that it was named the winner of eight Gold Stevie® awards in the 2017 International Business Awards. "The eight Stevie® awards earned highlight CallidusCloud's momentum, commitment to excellence, passion for innovation and customer orientation," said Leslie Stretch, president and CEO of CallidusCloud. "They also recognize the benefits that the Lead to Money suite, honored as the Best New Product in Business-to-Business, accrues to its customers in terms of enabling faster, bigger, and more profitable sales." CallidusCloud's Go
Ascom Myco and Koutio Médipôle optimize care communications and responsiveness16.8.2017 08:00 | Pressemelding
Ascom Holding AG / Ascom Myco and Koutio Médipôle optimize care communications and responsiveness . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. Enabled by the Ascom Myco smart device, the new Koutio Médipôle is realizing improved care delivery through seamless information flow from the point of care to anywhere. BAAR, Switzerland, Aug. 16, 2017 (GLOBE NEWSWIRE) -- The new Koutio Médipôle hospital in the New Caledonian capital Nouméa, located in the southwest Pacific Ocean, has optimized patient care communications and responsiveness for the new 645-bed facility by deploying Ascom Myco Wi-Fi devices to support clinician teams and Ascom Myco Wi-Fi/GSM handsets, used across paramedic teams. The Ascom solution is seamlessly aligned with clinical workflow and applications (nurs
VistaJet Harnesses the Power of the American Eclipse to Offer Customers a Rare Viewing Opportunity15.8.2017 18:40 | Pressemelding
VistaJet invites customers to fly in parallel with an astronomical anomaly NEW YORK, Aug. 15, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global aviation company, will be offering customers the opportunity to experience and chase the American Solar Eclipse, appearing for the first time in 99 years on August 21, 2017. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c0c41d7d-7ad9-4a46-9d2d-dcc1148b4772 The coast-to-coast National Eclipse and astronomical phenomenon will be visible in the United States from approximately 10:15AM PST, with the sun disappearing behind the moon from the Oregon coast, passing through 14 states to South Carolina. Without being in this 70-mile strip, Americans will not be able to see the sun eclipsed in totality. With unparalleled experience flying into and out of the hardest to reach destinations, VistaJet is offer
NGX Bio Raises $3 Million to Fund Growth of Its DNA Sequencing Marketplace15.8.2017 17:00 | Pressemelding
SAN FRANCISCO, Aug. 15, 2017 (GLOBE NEWSWIRE) -- NGX Bio, Inc., (www.NGXbio.com) the premier marketplace for online DNA sequencing services, announced it has closed a $3 million funding round. The round was led by 180 Degree Capital Corp. (NASDAQ:TURN) and included Third Kind Venture Capital, Lateral Capital, the Band of Angels and the Berkeley Angel Network, as well as other investors. NGX Bio was founded in 2014 to provide streamlined, on-line access to next-generation sequencing services for clients seeking high quality, rapid and cost-effective sequencing of both human and non-human samples globally. Demand for sequencing services is growing exponentially. NGX Bio's platform matches the sequencing needs of customers with providers who have available sequencing capacity. Customers are able to purchase a wide range of sequencing services for their samples using NGX Bio's online ordering tools. NGX Bio offers these services through numerous and deep relationships with its
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom