Invivoscribe Submits Pre-Market Approval Application in Japan and Panel Track Supplement in the US to Screen Acute Myeloid Leukemia (AML) Patients for FLT3 Mutations
SAN DIEGO, May 08, 2018 (GLOBE NEWSWIRE) -- Invivoscribe Technologies, Inc. announced today that they have submitted to Japan's Pharmaceutical and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) product registrations based on the ongoing Phase III CL-0301 ADMIRAL study evaluating gilteritinib for the treatment of FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML) in adult patients.
Invivoscribe Technologies Inc., in collaboration with Astellas Pharma Inc., has developed a companion diagnostic to aid in identifying these FLT3mut+ AML patients. In Japan, Invivoscribe submitted a pre-market approval application (Shonin) with the PMDA for the LeukoStrat® CDx FLT3 Mutation Assay and in the United States, Invivoscribe submitted a Panel Track Supplement to update the FDA-approved LeukoStrat CDx FLT3 Mutation Assay's Intended Use, specific for gilteritinib, should it be approved.
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 in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML. Invivoscribe was the first company to receive FDA approval for an AML companion diagnostic, with the approval of the LeukoStrat CDx FLT3 Mutation Assay in April of 2017.
"These submissions in Japan and the US represent a significant step in our ongoing efforts to harmonize molecular diagnostic testing for what is one of the most important driver mutations in AML in support of precision medicine," said Jeffrey Miller, CSO & CEO of Invivoscribe.
According to the American Cancer Society, each year around 20,000 new cases of AML are diagnosed in the US alone, with one-third of these being FLT3mut+.
Invivoscribe Technologies Inc. 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 fields of personalized molecular diagnostics and personalized molecular medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies developing and commercializing companion diagnostics.
For additional information please visit www.invivoscribe.com.
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
Elite Capital & Co. Limited upgrades its quality management system to ISO 9001:201522.5.2018 12:00 | Pressmeddelande
LONDON, May 22, 2018 (GLOBE NEWSWIRE) -- The Public Relations Department of Elite Capital & Co. Limited has announced that it has upgraded its Quality Management System from ISO 9001:2008 to ISO 9001:2015, prompted by its keen desire to provide its customers with the best services and assert its steady strides in the global finance market under the leadership of a management team that stands on a solid ground. On this occasion Elite Capital's chairman, Kuwaiti businessman, Dr. Faisal Khazaal expressed his deepest thanks and congratulations to the Company's president, Mr. George Matharu and the members of the Board of Directors and all the members of the company's executive management for their exceptional efforts toward raising customer service to the highest levels. Elite Capital & Co. Limited is a private limited company that provides project-related services, including management, consultancy and funding, particularly for large infrastructure and commercial projects. Elite Capital &
LeoVegas avslutar samarbetet med Frank Andersson22.5.2018 11:31 | Pressmeddelande
LeoVegas väljer att avsluta samarbetet med varumärkesambassadören Frank Andersson. Samarbetet avslutas då LeoVegas nyligen lanserat ett nytt kommunikationskoncept som bygger på flera varumärkesambassadörer. "Vi tackar för de år som Frank hjälpt till att profilera LeoVegas i Sverige. Han har varit en bidragande orsak till LeoVegas starka tillväxt på den svenska marknaden. LeoVegas har gått in i en ny fas med fler varumärken och en större bredd med fler produktkategorier. Efter ett långvarigt och framgångsrikt samarbete med Frank är det nu dags att ta nästa steg". säger Gustaf Hagman, CEO LeoVegas. " Jag har koncept och idéer på att utveckla egna spel och vill satsa mer på det, så det blir nästa steg för mig. Det har varit roliga år med LeoVegas och jag vill tacka LeoVegas för att dom har trott på mig och vi har haft riktigt kul tillsammans". säger Frank Andersson. För ytterligare information, vänligen kontakta: Gustaf Hagman, Group CEO: +46 (0) 8 410 367 66, email@example.com P
LeoVegas concludes partnership with Frank Andersson22.5.2018 11:31 | Pressmeddelande
LeoVegas has decided to conclude its partnership with brand ambassador Frank Andersson. The partnership is being concluded in connection with the recent launch by LeoVegas of a new communication concept that is based on several brand ambassadors. "We thank Frank for the years he has helped profile LeoVegas in Sweden. He has been a contributing factor behind LeoVegas' strong growth in the Swedish market. LeoVegas has entered a new phase with several brands and greater breadth with more product categories. After a long and successful cooperation with Frank, it is now time to take the next step," comments Gustaf Hagman, CEO of LeoVegas. "I have concepts and ideas for developing my own games and want to focus more on this, so that will be the next step for me," says Frank Andersson. "I had some great years with LeoVegas and want to thank LeoVegas for believing in me. We had a great time working together!" For further information, please contact : Gustaf Hagman, Group CEO: +46 (0) 8 410 367
Gunvor Group, Oceangold Tankers and Maas Capital Form ClearOcean Tankers JV22.5.2018 11:30 | Pressmeddelande
Gunvor SA / Gunvor Group, Oceangold Tankers and Maas Capital Form ClearOcean Tankers JV . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. "ClearOcean Tankers" has ordered 6 eco-friendly, scrubber-ready tankers NICOSIA, Cyprus, May 22, 2018 (GLOBE NEWSWIRE) -- Gunvor Group, one of the largest physical energy trading companies in the world, has entered into a joint venture with Oceangold Tankers and Maas Capital to form ClearOcean Tankers, a new ship holding company. The three partners hold an equal share in ClearOcean Tankers, which has been incorporated in Cyprus. ClearOcean Tankers has entered into shipbuilding contracts with STX Offshore & Shipbuilding Co. for four MR2 product tankers, and with Daehan Shipbuilding Co for two LR2 product tankers. All six of the contracted vessels will be delivered during the first half of 2019, and will be eco-friendly and scrubber-ready, in view of the International Marit
Doc re. GE Files Form 8-K22.5.2018 08:00 | Pressmeddelande
FAIRFIELD,Conn., May 22, 2018 (GLOBE NEWSWIRE) -- Company General Electric Company ISIN US3696041033 Symbol London: GEC | Paris: GNE Headline Doc re: GE files Form 8-K May 21, 2018 On May 21, 2018, General Electric Company (the "Company") filed a Form 8-K with the U.S. Securities and Exchange Commission ("SEC"), which has been submitted to the U.K. National Storage Mechanism and will be available shortly for inspection at http://www.morningstar.co.uk/uk/NSM. It is also available on the SEC's website at http://www.sec.gov and on the Company's website at https://www.ge.com/investor-relations/events-reports. CONTACT: GE Jennifer Erickson +001 646 682 5620 firstname.lastname@example.org This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, p
Introducing AbacusNext International, Technology Solutions Provider to the UK, Europe, and Beyond22.5.2018 07:00 | Pressmeddelande
US Based AbacusNext incorporates AbacusNext International in Edinburgh, the new international headquarters of their globally expanding TaaS platform EDINBURGH, United Kingdom, May 22, 2018 (GLOBE NEWSWIRE) -- AbacusNext®, the largest Technology-as-a-Service (TaaS) provider for the professional services sector, today announced that two-time Queen's Award Winner HotDocs Ltd-recently integrated into the AbacusNext family of products-will be reorganized under the newly incorporated AbacusNext International Ltd. The HotDocs brand and product suite will remain as a subsidiary within AbacusNext International's expanded slate of products and services for business. From its new headquarters in Edinburgh, Scotland, AbacusNext International will bring the fully-managed private cloud solutions and business technology services they pioneered in the North American market to the UK and Europe for the first time. The centerpiece of AbacusNext International's TaaS platform is Abacus Private Cloud, offe
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum