Update -- US FDA approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas drug XOSPATA (gilteritinib fumarate) for treatment of AML patients in the US
Invivoscribe also Receives National Reimbursement for CDx Assay in Japan
SAN DIEGO, Nov. 29, 2018 (GLOBE NEWSWIRE) -- Invivoscribe is pleased to announce FDA approval of both the LeukoStrat CDx FLT3 Mutation Assay and the Astellas drug, XOSPATA (gilteritinib fumarate), for treatment of FLT3 positive refractory/relapse acute myeloid leukemia (AML) patients in the US. Further, the Japanese MHLW has confirmed national reimbursement for the LeukoStrat CDx FLT3 Mutation Assay in Japan.
Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Astellas as the companion diagnostic to predict patient responses to Astellas Pharma's AML drug XOSPATA (gilteritinib fumarate).
This approval complements Invivoscribe’s prior regulatory approvals of this LeukoStrat CDx FLT3 Mutation Assay as the companion diagnostic for RYDAPT (midostaurin) for Novartis (United States and Europe), and XOSPATA (gilteritinib fumarate) for Astellas (Japan). This CDx was also recently submitted to the PMDA in Japan and the US FDA as the CDx for predicting response to the Daiichi Sankyo drug, quizartinib hydrochloride.
This milestone further establishes the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3 assessment for critically ill AML patients as this CDx identifies both ITD and TKD mutations (including large internal tandem duplications), is available worldwide, and generates standardized signal ratios for both ITD and TKD mutations.
“Invivoscribe welcomes opportunities to use our Streamlined CDx™ program to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether their therapies are targeting hematologic diseases or solid tumors,” said Jeffrey Miller, Invivoscribe’s CSO and CEO.
About the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to detect internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia. This globally standardized test includes software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to both gilteritinib fumarate and midostaurin. This extensively validated assay helps standardize the detection of genetic mutations in the FLT3 gene as one of the most important driver mutations in Acute Myeloid Leukemia (AML).
The LeukoStrat test is available as a test menu service through the Invivoscribe subsidiaries, LabPMM LLC (San Diego, CA, US), LabPMM GmbH (Martinsried, Germany) and LabPMM GK (Kawasaki City, Japan). LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Europe, will be available in Japan in 2018, and are planned for distribution in the United States, and China in the future.
Invivoscribe is a privately held biotechnology company dedicated to Improving Lives with Precision Diagnostics ™. For nearly twenty-five years, Invivoscribe has improved 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, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.
One Liberty Plaza - 165 Broadway
NY 10006 New York
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
Test Release - 25-05-2019 - 21108925.5.2019 15:39:00 CEST | Pressemelding
Test Sub Headline - 2067088 Chicago, May 25, 2019 (GLOBE NEWSWIRE) -- American HealthCare Lending, the leading non-recourse patient financing platform serving health systems, physician groups, surgical centers, and other healthcare providers throughout the country, today announced that it will showcase its patient financing platform at the Healthcare Financial Management Association's ANI 2014 Conference in Las Vegas June 22-25. Hosted by the nation's leading membership organization for healthcare financial management executives and leaders, HFMA's 2014 National Institute is a place for top executives and key decision makers to explore solutions to the most pressing issues facing the industry. American HealthCare Lending's patient financing solution addresses one of these key issues, the dramatic rise in out-of-pocket patient responsibility, by delivering financing options designed to fulfill the company's mission to Make Healthcare Affordable™. Attachment sample
Biome Grow Inc. to Announce First Quarter Fiscal 2019 Financial Results.24.5.2019 19:08:00 CEST | Pressemelding
TORONTO, May 24, 2019 (GLOBE NEWSWIRE) -- Biome Grow Inc. (“Biome” or the “Company”) (CSE:BIO, OTCQB: BIOIF, 6OTA:GR) will release its financial results for the first quarter ended March 31, 2019 before market open on May 29, 2019. Following the release of its first quarter 2019 financial results, Biome will host a conference call and audio webcast with Khurram Malik, CEO at 8:30am Eastern Time May 29, 2019. Webcast information A live audio webcast will be available at https://event.on24.com/wcc/r/2015980/CEAD1B37BDD7710D021A38D2B79B5C45 Calling Information Toll Free Dial-In Number: 1 (866) 211 3199 International Dial-In Number (647) 689 6601 Conference ID 8693906 About Biome Biome wholly owns five subsidiaries, including: The Back Home Medical Cannabis Corporation, a company incorporated under the laws of the Province of Newfoundland and Labrador and in the late stages of applying for a license under the Cannabis Act; Great Lakes Cannabis, a company incorporated under the laws of the
Jason Lamb of Gates Foundation Named New Chair of CGAP’s Executive Committee24.5.2019 17:04:00 CEST | Pressemelding
CGAP CEO calls for renewed focus on retail credit to support growth and jobs for the poor Beirut, Lebanon, May 24, 2019 (GLOBE NEWSWIRE) -- Jason Lamb from the Bill & Melinda Gates Foundation, was elected chair of the Executive Committee for The Consultative Group to Assist the Poor (CGAP) at its annual meeting on Wednesday. Lamb will succeed Carolina Trivelli, senior researcher at the Instituto de Estudios Peruanos and Peru’s former Minister of Development and Social Inclusion. Under Trivelli’s leadership CGAP adopted its new five-year strategy and theory of change that places empowering the poor through financial services to capture opportunities and build resilience at the heart of CGAP’s work. At the Gates Foundation, Lamb is Deputy Director, Financial Services for the Poor (FSP) and manages focus country implementation in Bangladesh, Pakistan, Indonesia, Nigeria, Tanzania, Kenya and Uganda. He has served on CGAP’s Executive Committee, which functions like a board of directors prov
Gainsight Unveils the Customer Cloud, the Future of Customer Success Technology23.5.2019 19:30:00 CEST | Pressemelding
New Products Announced at Pulse 2019 to Drive Customer Success Across the Enterprise SAN FRANCISCO, May 23, 2019 (GLOBE NEWSWIRE) -- Today, Gainsight® launched the Customer Cloud —a first-of-its-kind solution for subscription businesses looking to adopt a customer-centric philosophy that enables them to retain customers while also driving company growth post-sale. According to the 2018 Subscription Economy Index report, subscription companies are growing five times faster than S&P and retail sales. The Gainsight Customer Cloud caters to these businesses by combining the company’s Customer Success and Product Experience products with three new product innovations to offer a powerful set of solutions for businesses to optimize their subscription strategies through technology. “With the maturity of cloud technology and the subscription economy, customer expectations have drastically changed. Companies are struggling to leverage existing tools to satisfy the increasing demands of their cus
Lowered Return Expectations Among Several Trends Pointing to a Shift in Private Markets Due Diligence says New eVestment Survey23.5.2019 15:30:00 CEST | Pressemelding
ATLANTA, May 23, 2019 (GLOBE NEWSWIRE) -- Private markets funds have continued to rake in new commitments from institutional investors eager to diversify their portfolios and capture the returns private markets investments can offer. However, investors are now tempering their private markets return expectations. Coupled with other industry trends, this will have implications for private markets fundraising and due diligence according to a new eVestment report, produced in association with parent company Nasdaq. The 2019 eVestment Private Markets Due Diligence Survey of institutional investors, consultants and private markets fund managers finds that 52% of investors expect returns in the space to decline in the future (page 16). Only 12% of investors expected private equity returns to increase, with the balance – 36% – expecting returns to stay about the same. Forty-seven percent of investors surveyed expect to see lower returns in venture capital vs. just 16% of investors who expect r
Collibra Announces 2019 Excellence Awards Winners23.5.2019 15:00:00 CEST | Pressemelding
American Express, Deloitte, and Lloyds Banking Group recognized as leaders in harnessing data to drive digital transformation NEW YORK, May 23, 2019 (GLOBE NEWSWIRE) -- Collibra, the leader in enterprise data governance and catalog software, today announced the winners of the 2019 Collibra Excellence Awards. Presented at the annual Data Citizens conference in New York, the awards honor teams and individuals driving innovative data strategy by collaborating with Collibra. “In today’s market, organizations that are able to maximize data have the power to transform entire industries,” said Felix Van de Maele, co-founder and CEO of Collibra. “We’re proud to honor the recipients of the Collibra Excellence Awards, a cutting-edge group at the forefront of data-driven innovation.” The 2019 Collibra Excellence Award Winners: American Express — Distinguished Data Program of the Year American Express was recognized for its data governance transformation, which began as a compliance initiative and