GlobeNewswire

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

Share

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.

About Invivoscribe
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.

For additional information please contact Invivoscribe at support@invivoscribe.com or visit www.invivoscribe.com.

About 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.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

ObsEva to Increase Issued Share Capital by Creating Additional Treasury Shares18.7.2019 07:00:00 CESTPress release

Geneva, Switzerland and Boston, MA – July 18, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, announced today that its board of directors approved an increase of its share capital from 45,491,616 to 48,555,664 through the issue of 3,064,048 new registered shares at an issue price of 1/13 of a Swiss Franc each. The new shares, to be issued out of the company's authorized capital, will be fully subscribed for by ObsEva USA Inc., its 100% wholly owned subsidiary, and listed on the SIX Swiss Exchange on or around July 23, 2019. The transaction has been decided to provide the group with additional treasury shares that can be used in the future to raise funds in an efficient manner, as well as for the equity plans of the company and its subsidiaries. About ObsEva ObsEva is a clinical-stage biop

SDRL – Seadrill Limited Announces Contract Award for the West Gemini17.7.2019 22:35:00 CESTPress release

Hamilton, Bermuda, July 17, 2019 - Seadrill Limited ("Seadrill" or "the Company") has secured a nine well contract with three options, each for two wells, for the West Gemini in West Africa. Total contract value for the firm portion of the contract is expected to be approximately $84 million with commencement expected in early Q4 2019 and running through Q4 2020. FORWARD LOOKING STATEMENTS This news release includes forward looking statements. Such statements are generally not historical in nature, and specifically include statements about the Company's plans, strategies, business prospects, changes and trends in its business, the markets in which it operates and its restructuring efforts. These statements are made based upon management's current plans, expectations, assumptions and beliefs concerning future events impacting the Company and therefore involve a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed or imp

GrandVision confirms HAL and EssilorLuxotica are engaged in discussions on a possible sale of controlling interest of HAL in GrandVision17.7.2019 18:45:00 CESTPress release

Schiphol, The Netherlands - 17 July 2019. GrandVision NV (Euronext: GVNV) confirms that it has been approached by EssilorLuxottica SA (Euronext: EL) and HAL Holding NV (Euronext: HAL) in connection with a possible sale of HAL’s 76.72% ownership interest in GrandVision to EssilorLuxottica at an envisaged purchase price per share of approximately EUR28.00. At this stage it is uncertain whether an agreement between EssilorLuxottica and HAL will be reached. While a transaction would be between HAL and EssilorLuxottica, GrandVision’s support has been requested. Completion of a sale of HAL’s ownership interest in GrandVision would be subject to customary conditions including approval from relevant regulatory authorities in various jurisdictions, which may take between 12 and 24 months. Following completion of the transaction between HAL and EssilorLuxottica, EssilorLuxottica will make a (mandatory) public offer for all shares in GrandVision. Further announcements will be made if and when req

Solutions 30 : 79.8% revenue growth in the first half of 201917.7.2019 18:00:00 CESTPress release

79.8% revenue growth in the first half of 2019 France: revenue up 74.4% Other countries: revenue up 90.3% Reliable, cash-generating model Solutions 30 SE, the European leader in solutions for new technologies, today disclosed its revenue for the first half of 2019 . In millions of euros (Unaudited figures) HY Q2 2019 2018 % change 2019 2018 % change Total 317.8 176.7 +79.8% 157.4 91.5 +72.1% From France 202.8 116.3 +74.4% 101.5 59.5 +70.6% From other countries 115.0 60.4 +90.3% 55.9 32.0 +74.7% Sustained growth trend continues Solutions 30 maintains its high growth trajectory, disclosing revenues of €317.8 million for the first half of 2019, a 79.8% increase (36.9% of which was organic growth1). For the 2nd quarter alone, revenue increased by 72.1%, reaching €157.4 million. Organic growth represented 32.3%. The group continues to demonstrate the relevance of its positioning and strategy in markets driven by the economy’s digital transformation and major technology groups’ outsourcing o

ObsEva Hosts KOL Meeting on IVF Trends, Unmet Need and Market Potential of Nolasiban17.7.2019 18:00:00 CESTPress release

Company remains on track to submit Nolasiban MAA in the fourth quarter of 2019 GENEVA, Switzerland and BOSTON, MA - July 17, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today hosted a key opinion leader (KOL) meeting in New York City on in-vitro fertilization (IVF). At the event, three KOLs in women’s reproductive health along with company executives discussed trends in IVF, including current practice trends toward Day 5 embryo transfer, and the merits of single-embryo transfer (SET) vs. double embryo transfer (DET). Further, event participants discussed the potential clinical importance of nolasiban, ObsEva’s oral oxytocin receptor antagonist, to significantly improve the live birth rate (LBR) resulting from ET, and address the high physical, emotional and financial pain associated with fa

Bizagi goes from Stealth to Hyper Growth Delivering Digital Transformation for World Leading Brands17.7.2019 18:00:00 CESTPress release

From Adidas and Audi to Ikea and the U.S. government, Bizagi’s unique Intelligent Process Automation helping organizations harness the power of RPA and AI to speed transformation SANTA CLARA, Calif., July 17, 2019 (GLOBE NEWSWIRE) -- Bizagi, the world’s leading Intelligent Process Automation platform provider, today announced significant growth in the U.S. and abroad driven by its success enabling digital transformation for world leading brands such as DHL, Gap, Citizens Bank, AON and numerous U.S. government agencies including the Departments of Agriculture, Defense, Energy, HHS, Homeland Security and many others. Bizagi’s growth is based on enterprise adoption of its unique Intelligent Process Automation, enabling companies to better leverage digital and robotic processes, along with artificial intelligence, to improve customer interaction, speed operations and build revenue. This news follows the company’s recognition last month as a leader in The Forrester Wave™: Software for Digit