Invivoscribe Submits LeukoStrat CDx FLT3 Mutation Assay both in the US and Japan to Support Daiichi Sankyo Submissions for Quizartinib
SAN DIEGO, Nov. 27, 2018 (GLOBE NEWSWIRE) -- In support of an ongoing partnership with Daiichi Sankyo, Invivoscribe is pleased to announce submissions of the LeukoStrat® CDx FLT3 Mutation Assay to both the US FDA and the Japan PMDA (Pharmaceuticals and Medical Devices Agency) as the companion diagnostic for quizartinib, which follows Daiichi Sankyo’s respective FDA and PMDA applications for quizartinib in the US and in Japan.
Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Daiichi Sankyo as the companion diagnostic that bridges to the global phase 3 QuANTUM-R clinical trial (Europe, United States, Asia excluding Japan) in patients with relapsed/refractory FLT3 ITD AML. Together, the QuANTUM-R clinical trial and open-label phase 2 study of quizartinib (Japan) support the Daiichi Sankyo New Drug Application (NDA) to Japan’s MHLW/PMDA and the FDA in the US for use of quizartinib for treatment of adult patients with relapsed/ refractory FLT3 ITD acute myeloid leukemia (AML).
Timing of this submission reflects the efficiencies of Invivoscribe’s Streamlined CDx ™ program, which integrates a range of CDx activities including development, clinical trials support with rapid patient screening for enrollment, regulatory support and, importantly, commercialization. In addition, they complement Invivoscribe’s prior regulatory approvals of this LeukoStrat CDx FLT3 Mutation Assay as an AML companion diagnostic in support of midostaurin for Novartis (United States and Europe), and gilteritinib fumarate for Astellas (Japan). Astellas and Invivoscribe have also submitted applications for the drug and device to the CDER and CDRH, respectively, in the United States.
This milestone also establishes the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3 assessment for critically ill acute myeloid leukemia patients as this CDx identifies even the largest ITD mutations, is available worldwide, and generates standardized signal ratios for both ITD and TKD mutations. These criteria are already resulting in more consistent stratification of patients which will help prescribing doctors identify personalized therapy options for their patients and accelerate new drug and therapy approvals by establishing more homogeneous patient populations for clinical trials.
“These LeukoStrat CDx FLT3 Mutation Assay submissions and continuing Daiichi Sankyo partnership represent significant milestones for our company. We welcome opportunities 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). In serving as the companion diagnostic to the Daiichi Sankyo sponsored clinical trials, this test reports out FLT3 ITD mutations alone.
The LeukoStrat test is currently 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. Distribution of kits in Japan, United States, and China are planned.
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
Industry-leaders join BIOPAC for T4 Human Physiology Conference Set for August 12-14, 201919.12.2018 01:34 | Pressemelding
Training and Best Practices for Measuring Physiology GOLETA, Calif., Dec. 18, 2018 (GLOBE NEWSWIRE) -- BIOPAC Systems, Inc., announced the second biennial T4 Human Physiology Conference to be held August 12-14, 2019 at the University of California Santa Barbara (UCSB). Life science researchers, educators, and students are invited to learn the latest Tools, Trends, Techniques, and Technology used in physiological measurement and interpretation. T4 sessions offer hands-on, practical tips and tricks, giving participants the latest tools and insights to pursue scientific discovery with significant amounts of data from multiple participants and devices, in or out of the lab. BIOPAC hosts the T4 Physiology Conference to increase understanding of physiological measurements. Frazer Findlay, BIOPAC CEO, says, “BIOPAC has always placed a strong emphasis on working with partners that understand the industry and the needs of our customers. I am delighted that we’ll have partners joining us at T4 t
RCI Banque S.A.: Post Stabilisation Notice18.12.2018 15:55 | Pressemelding
PARIS, Dec. 18, 2018 (GLOBE NEWSWIRE) -- 18th December 2018 RCI Banque S.A. Post Stabilisation Notice HSBC (contact: Syndicate desk, telephone: +44 207 992 8066) hereby gives notice that no stabilisation (within the meaning of the rules of the Financial Conduct Authority) was undertaken in relation to RCI Banque S.A. GBP Fixed due 30th Oct 2023 because the transaction did not complete. Issuer: RCI Banque S.A. Guarantor (if any): NA Aggregate nominal amount: GBP Benchmark Description: Fixed due 30th Oct 2023 Offer price: na Stabilising Managers: HSBC, Lloyds, Natwest This announcement is for information purposes only and does not constitute an invitation or offer to underwrite, subscribe for or otherwise acquire or dispose of any securities of the Issuer in any jurisdiction. 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 condit
The North American Bitcoin Conference Stands Out as One of 2019’s Most Important Worldwide Crypto Events18.12.2018 15:35 | Pressemelding
MIAMI, Dec. 18, 2018 (GLOBE NEWSWIRE) -- via CryptoCurrencyWire – 2019 will kick off with what has become widely accepted as one of the most important blockchain conferences of the year. The North American Bitcoin Conference, sponsored by Keynote and part of the World Blockchain Forum, will take place Jan. 16-18, 2019, at the James L. Knight Center in Miami, Florida. This premier crypto conference, now in its seventh year, will draw cryptocurrency and blockchain leaders from all across the globe as they come together for this historical event. The North American Bitcoin Conference is the longest-running, most-attended finance conference for the blockchain and crypto industries, with each event attracting thousands of attendees. The 2019 conference will feature a lineup of more than 60 world-class presenters, including technology veterans and company founders who have collectively raised more than $18.1 billion in initial coin offerings (ICOs). Speakers that have been announced thus far
Inspirata Subsidiary, Artificial Intelligence in Medicine (AIM), Signs Contract with the National Cancer Institute (NCI) to Use Its E-Path Reporter Software for Reporting by U.S. Central Cancer Registries18.12.2018 15:06 | Pressemelding
The NCI has licensed AIM’s E-Path Reporter software for the last 15 years to provide an automated solution that enables cancer registries to more efficiently collect and report cancer incidence and survival data. Toronto, CA, Dec. 18, 2018 (GLOBE NEWSWIRE) -- Artificial Intelligence In Medicine Inc. (AIM), an Inspirata company, announced today that the National Cancer Institute (NCI) has extended its license agreement for AIM’s E-Path Reporter software. The software has been licensed for use within the SEER (Surveillance, Epidemiology and End Results) program, for 14 central registries and 286 major reporting hospitals and laboratories across the U.S. NCI supports cancer data collection and research through the SEER program and publishes cancer statistics for 20 U.S. geographic areas. The NCI requires participating cancer registries to collect data on cancer patient demographics, primary tumor site, tumor morphology and disease stage at diagnosis. The registries also must report on fir
Crown Bioscience Creates Center of Excellence for Bioinformatics, Big Data, and Biomarker Discovery Services18.12.2018 14:30 | Pressemelding
Services and Capacity Increase with New Site Opening SAN DIEGO, Dec. 18, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, has recently announced the expansion of its existing translational oncology research capacity by opening a new site in Suzhou, Jiangsu, China. The large amount of data now available from preclinical and clinical research requires specialized expertise in bioinformatics, big data analysis and dedicated storage facilities. CrownBio’s new site will focus on integrating the company’s experience in preclinical and translational research with cutting-edge digital technologies for the discovery of predictive biomarkers and the development of new and companion diagnostics. The Suzhou site will become CrownBio’s center of excellence for systems biology and clinical sample testing. Located at the heart of the Bi
Family of Constant-Current Dimmable Buck LED Drivers18.12.2018 11:00 | Pressemelding
1.5A, 3A Buck LED Drivers Target ISO26262 automotive and industrial applications MILPITAS, Calif., Dec. 18, 2018 (GLOBE NEWSWIRE) -- AMS, the Analog Mixed-Signal division of ISSI, has introduced a family of switching buck LED Drivers for automotive and industrial applications. This family of highly integrated switching constant current buck LED Drivers are targeted for 12V/24V battery connected, space-constrained, electromagnetic (EMC) sensitive applications such as Headlight, Front and Rear Fog lights, Day time Running lights to name a few. The device family supports a wide DC voltage input range of 4.5V to 38V and outputs a 5% regulated current of 1.5A or 3A; depending on the particular device, see table. The integrated power MOSFET is configured to switch in the constant on-time mode delivering true average current. Switching at a frequency of up to 2MHz which is adjustable with an external resistor, these buck LED Drivers can use smaller output inductor and capacitor values thereby