PRNewswire | July 27, 2023
Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib).
The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3-ITD positive AML patients who may be treated with this newly approved targeted therapy.
US Intended Use
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (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 acute myelogenous leukemia (AML).
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered.
The test is for use on the 3500xL Dx Genetic Analyzer.
"FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML," said Invivoscribe CSO, CEO, and founder Jeffrey Miller. "Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with VANFLYTA, and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients."
AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 About 25% of AML patients have a FLT3-ITD mutation which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.
Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select FLT3-ITD positive AML patients eligible for VANFLYTA in Japan.
Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty 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.
Cell and Gene Therapy
prnewswire | September 14, 2023
Ceres Nanosciences, a global leader in developing wastewater testing methods based on its Nanotrap® technology, and Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced that they are partnering to bring pathogen monitoring capabilities to laboratories around the world. Pathogen monitoring and analysis capabilities, including in wastewater, are designed to help public health institutions address regional biosecurity challenges.
Supported by the NIH RADx Initiative, Ceres developed their Nanotrap technology for robust, sensitive, and time-saving methods to detect a wide range of pathogens in wastewater samples and has deployed those methods to a network of testing sites in the United States. These sites provide wastewater testing services nationwide to deliver valuable public health data, such as information about the relative abundance of COVID-19 variant groups over time in a community's wastewater, to the CDC's National Wastewater Surveillance System and to state, local, and Tribal decision makers.
Recently, Concentric by Ginkgo, the biosecurity unit of Ginkgo Bioworks, as part of a CDC program, demonstrated in a study with partners from XPresCheck and Louisiana State University that coupling Ceres' aircraft wastewater testing methods with Concentric's analysis can enable early detection of variants of SARS-CoV-2. San Francisco International Airport was the first airport to announce that it will continuously monitor airplane wastewater samples as part of a CDC program operated by Concentric and XpresCheck.
Under the partnership between Ceres and Concentric, labs in countries where Concentric has biosecurity programs receive on-site training and the materials needed to implement the standardized and proven wastewater testing workflow from Ceres. Labs also receive biosecurity tools and data infrastructure to leverage automation, data analysis, bioinformatics capabilities, and other critical genomic sequencing technologies.
Together, Ceres and Concentric have set up labs in the Middle East and Africa through this collaboration, offering a cutting-edge approach to biosurveillance technologies and capacity building for labs around the world that are part of Concentric's global pathogen monitoring network.
"Under our NIH RADx Initiative, we demonstrated that we can quickly stand up improved wastewater testing capabilities for labs that are experts or novices in the space," said Robbie Barbero, Chief Business Officer at Ceres Nanosciences. "We are delighted now to be partnering with a global leader like Concentric to build a robust public health framework worldwide."
"Ceres Nanosciences has been a terrific partner in developing effective and innovative methods for identifying pathogens in wastewater," said Matt McKnight, General Manager, Biosecurity at Ginkgo Bioworks. "By combining their laboratory expertise with our global footprint, we are building a robust global biological radar to prevent, detect, and respond to biological threats."
About Ceres Nanosciences, Inc.
Ceres Nanosciences is a privately held company, located in Northern Virginia, focused on incorporating its proprietary Nanotrap® particle technology into a range of diagnostic and research use products and workflows. Nanotrap particles capture, concentrate, and preserve low abundance analytes from biological samples, enabling early and accurate detection of diseases. The Nanotrap particle technology was developed with support from the National Institutes of Health, the Defense Advanced Research Projects Agency, the Bill and Melinda Gates Foundation, Schmidt Futures, the Defense Threat Reduction Agency, the Centers for Disease Control and Prevention, and the Commonwealth of Virginia.
About Ginkgo Bioworks
Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats.
Research, Industry Outlook
PRnewswire | July 06, 2023
LuminUltra today announced the launch of BugCount® Fuel, an innovative, user-friendly test kit to quickly and accurately evaluate fuels for microbial contamination which can cause significant challenges for a range of industries including aviation, marine, and fuel handling.
Microbiological testing of fuel is critical for identifying and getting ahead of issues that lead to compromised performance, including clogged filters, worn injectors, fuel tank lining (pitting) corrosion, and even engine failure. The need for effective, fast microbiological testing solutions in industries including aviation is quickly increasing in the wake of growing passenger and freight transport demand, increased recreational travel, and a widespread adoption of green initiatives, such as sustainable aviation fuel (SAF).
"We've heard from our partners in the industry that it's more critical than ever for them to perform regular microbial testing on fuels, and to be able to get accurate, reliable results as quickly as possible" says Dr. Jordan Schmidt, Senior Director of Technology & Innovation at LuminUltra. "All of this fed into the development of BugCount® Fuel – filling that gap with a test that can be operated under-wing, providing results in minutes and with the accuracy needed to produce truly actionable results. Also, our in-house experts are available and keen to help in assessing the risk of microbial growth in fuels as this market continues to evolve."
A powerful new application of a proven technology
LuminUltra's patented 2nd Generation ATP kit has been a gamechanger for microbial testing for industry since it was first introduced in 2003. Originally designed for bioreactor optimization and now used across a range of industrial applications, it combines the speed of ATP testing – results are returned in just 5 minutes – with modifications that make the test significantly more accurate and sensitive than traditional ATP tests. LuminUltra's 2nd Generation ATP® is the only tool that allows the end user to quickly perform the test and compare the results across testing events, allowing long-term trend analysis and, ultimately, informed decision-making.
BugCount® Fuel leverages this 2nd Gen ATP technology in an industry-specific test kit, enabling the user to operate the entire test on-site in just minutes. All required components are included and designed for use with minimal training or expertise. The product has already been successfully implemented in both commercial and general aviation applications, and this new kit is a series of improvements on an existing test kit that has been used in these markets for years. It allows for testing in accordance with ASTM D7687 and is referenced in the latest 6th Edition of the IATA Guidance Material on Microbial Contamination in Aircraft Fuel Tanks.
"We're incredibly proud of today's announcement. It's yet another proof of our success in delivering our core purpose, 'to be your partner in microbial management'" says LuminUltra CEO, Pat Whalen. "We have a history of serving these markets and we're already hearing very positive feedback on the updates we've made to our kits. We pride ourselves on our operational capabilities, manufacturing all of our solutions in-house, which ensures our ability to meet industry demand and turnaround times. We're excited to put this critical tool in the hands of more customers to help more industries stay ahead of the challenges of unchecked microbiological activity."
Founded in 1995, LuminUltra is a global leader in applied molecular biology diagnostics, with solutions and services that deliver accurate and actionable feedback in bioprocessing, biofouling, and biosecurity applications. With operations in six countries, LuminUltra serves dozens of Fortune 500 customers across more than 100 countries. In recent years it has been on an accelerated growth path, acquiring multiple companies after forming a partnership with XPV Water Partners.