GlobeNewswire

Invivoscribe® Receives Approval in Japan for its LeukoStrat® CDx FLT3 Mutation Assay to Assess Acute Myeloid Leukemia (AML) Patients Eligible for Treatment with Xospata® (gilteritinib fumarate)

Del

SAN DIEGO, Sept. 27, 2018 (GLOBE NEWSWIRE) -- Invivoscribe® Inc., a global company providing biomarker and clonality test solutions for the fields of oncology and personalized molecular medicine ® today announces Pharmaceuticals and Medical Devices Agency (PMDA) approval of the LeukoStrat CDx FLT3 Mutation Assay companion diagnostic.

As the first company to receive both FDA and PMDA approval for an acute myeloid leukemia (AML) companion diagnostic, Invivoscribe continues our mission for global standardization of diagnostic testing and expanding our global laboratory network.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the  FLT3 gene. The globally standardized test includes software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to gilteritinib fumarate.

Invivoscribe developed this companion diagnostic as an aid in identifying FLT3 mut+ AML patients eligible for treatment with gilteritinib fumarate (Xospata®). FLT3 somatic variants are among the most common driver mutations with the strongest effects on the overall survival in acute myeloid leukemia1. This companion diagnostic screened subjects for enrollment eligibility into the Phase 3 ADMIRAL study evaluating gilteritinib fumarate for the treatment of FLT3 mutation-positive (FLT3 mut+) relapsed or refractory AML adult patients.

The LeukoStrat CDx FLT3 Mutation Assay is available as a commercial service offering from LabPMM GK in Japan to identify FLT3 mut+ AML patients for possible Xospata® treatment.  Distributable LeukoStrat CDx FLT3 Mutation Assay Kits are expected to begin shipment from LabPMM GK, the Marketing Authorization Holder (MAH) in Japan, in late 2018. 

“Invivoscribe has long been committed to international standardization of molecular diagnostic tests. Test standardization is a critical part of precision medicine as it helps to refine treatments and accelerate drug approvals. Approval of our LeukoStrat CDx FLT3 Mutation Assay in Japan follows on the approval of the same test by the FDA in the US last year. These milestones represent a significant step towards standardized detection of one of the most important driver mutations in AML.”, said Jeffrey Miller, CSO & CEO of Invivoscribe.

Invivoscribe is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics. LabPMM GK is an accredited subsidiary of Invivoscribe. 

For additional information please contact LabPMM GK at support@labpmm.com or visit www.invivoscribe.com/clinical-services.

1) Papaemmanuil E, Gerstung M, Bullinger L, et al. N Engl J Med 2016; 374(23):2209-2221

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

Standard Lithium Announces Positive Preliminary Economic Assessment and Upgrading of Mineral Resource at Its Southern Arkansas Lithium Brine Project19.6.2019 09:00:00 CESTPressemelding

VANCOUVER, British Columbia, June 19, 2019 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. (“Standard Lithium” or the “Company”) (TSXV: SLL) (OTCQX: STLHF) (FRA: S5L), is pleased to announce the results of a Preliminary Economic Assessment (PEA) of its 150,000 acre project in the south-central region of Arkansas, USA (the “Property”). The PEA considers the production of battery-quality lithium carbonate through a phased build-out to a total 20,900 tonnes per annum (tpa) from the contemplated joint venture with Lanxess Corp. (see press release dated November 12, 2018) at their three-operating bromine-processing plants. The PEA also includes the reclassification of the existing mineral resource to an Indicated category. The PEA was prepared by Advisian, the consulting arm of WorleyParsons Canada Services Ltd (Worley), a world-leading integrated engineering firm with extensive experience in the design and construction of chemical plants and lithium brine processing projects around the globe. Ke

Data Privacy and Governance Solution Now Cloud-based18.6.2019 18:34:00 CESTPressemelding

HIPAAT Privacy eSuite adds support for Consent as a Service, enabling consumers to have direct control over their personal information NAPLES, FL and TORONTO, ON, June 18, 2019 (GLOBE NEWSWIRE) -- HIPAAT Inc. (HIPAAT), a leading provider of consent management, privacy-based access control and auditing solutions, today announced the release of version 6.0 of its consent engine, Privacy eSuite (PeS). The new version supports consumers’ ability to have direct control over their personal information privacy preferences. Those preferences may be recorded and managed, and – most importantly – consulted prior to their information being collected, used or disclosed. V6.0 improvements include support for HL7 Fast Health Interoperability Resources (FHIR) R4 for managing privacy policies and consent directives, RESTful interfaces for consent decisions and override requests, OAuth 2.0 protection for APIs as resources, and Open ID Connect and OAuth 2.0 for authenticating users and providing user pe

Boom Supersonic Partners with Prometheus Fuels to Supply Carbon Neutral Fuel for XB-1, its Mach-2.2 Demonstrator Aircraft18.6.2019 17:00:00 CESTPressemelding

Prometheus Fuels extracts CO2 from the air, creating hydrocarbon fuel with zero impact on greenhouse gas levels DENVER, June 18, 2019 (GLOBE NEWSWIRE) -- Boom Supersonic, the Colorado company building history’s fastest supersonic airliner, today announced a unique partnership with Prometheus Fuels. Prometheus will supply fuel during the flight test program of XB-1, Boom’s Mach-2.2 demonstrator aircraft. Boom plans to use Prometheus fuel to power XB-1 in the world’s first supersonic flight using carbon-neutral fuel. Through a process called direct air carbon capture, Prometheus removes carbon dioxide (CO2) from the air and uses clean electricity to transform it into gasoline, diesel, and jet fuel. The electricity used in this process comes from renewable sources such as solar and wind, so there are no net carbon emissions from using the fuel. “Boom is committed to making supersonic travel environmentally sustainable—we want society to enjoy the benefits of faster flight for generations

Parallels® Remote Application Server 17 Brings Simplicity and Scalability to End User Computing for Microsoft RDS, VDI and DaaS with Time-Saving Innovations18.6.2019 15:01:00 CESTPressemelding

BELLEVUE, Wash., June 18, 2019 (GLOBE NEWSWIRE) -- Today Parallels released version 17 of Parallels® Remote Application Server (Parallels RAS, parallels.com/ras) which simplifies end user computing for service providers (SPs) and enterprises. Parallels RAS 17 enables faster launch of applications by using artificial intelligence (AI), provides additional security features such as integration with Google Authenticator, and debuts a web-based helpdesk console to more easily manage Microsoft Remote Desktop Services (RDS), virtual desktop infrastructure (VDI) and desktop as a service (DaaS) infrastructure. Parallels RAS 17 is an all-in-one solution that empowers end users to consume business applications faster, reliably, and with the ability to scale within a single cloud or multiple clouds. SPs and enterprises can benefit from the Parallels RAS investment in improved management and deployment components. These provide new methods to control DaaS, VDI and Microsoft RDS, such as a new REST

Abeona Therapeutics Receives FDA Fast Track Designation for ABO-202 AAV9 Gene Therapy in CLN1 Disease18.6.2019 14:29:00 CESTPressemelding

NEW YORK and CLEVELAND, June 18, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its ABO-202 program. ABO-202, the Company’s novel one-time AAV9 gene therapy for CLN1 disease, is designed to deliver a functional copy of the PPT1 gene to the central nervous system and peripheral organs using a combination of intravenous and intrathecal administrations. Abeona is preparing to initiate a Phase 1/2 clinical trial evaluating ABO-202 in patients with CLN1 disease and will provide guidance on the timing of the trial later this year. “Receiving Fast Track designation acknowledges the urgency for developing a therapy for children suffering from this rapidly-progressing and fatal disease and highlights the significant potential of ABO-202 to address this unmet need,” said João Siffert, M.D., Chief Executive Officer. ABO-202 i

Nasdaq Launches Center for Corporate Governance18.6.2019 14:00:00 CESTPressemelding

New Informational Hub to Advance Global Insights and Research on Corporate Governance and Sustainability Practices for Public, Private, and Nonprofit Organizations Publishes Inaugural Research Report on Board and Investor Priorities of S&P 100 Companies NEW YORK, June 18, 2019 (GLOBE NEWSWIRE) -- Nasdaq, Inc. (Nasdaq: NDAQ) today announced the founding of the Nasdaq Center for Corporate Governance (the “Governance Center”), a global information and research hub that will integrate Nasdaq’s expertise, insights, and technology to accelerate the understanding of emerging corporate governance and sustainable business practices. The ambition of the Governance Center is to support the work of boards, senior executives, and governance professionals at public, private, and nonprofit organizations. “Our mission with the Governance Center is to create a resource for corporate leaders, investors, and stakeholders that includes the latest governance insights and actionable intelligence, thereby su