January 28, 2021 | Saliva for early lunch cancer detection, new guidelines for diagnosis of bleeding disorder, Babson claims fingerstick diagnostics in a retail setting, and looking at Alzheimer’s. Plus: companion diagnostic agreements, and genomic sequencing for prenatal testing.
Spectrum Solutions and the UCLA School of Dentistry are collaborating on a study using saliva in early lung cancer detection and analysis. Spectrum has funded a study that aims to recruit 50 patients with lung cancer and seeks to validate saliva’s tumor-specific ctDNA detection sensitivity and positive agreement against tissue biopsy-based genotyping. Saliva will be collected, preserved, and transported for DNA testing using Spectrum’s Saliva Collection System. The company will further support the development of clinical methods and additional technical innovations. The study is being led by professor of oral biology, Dr. David Wong, from the UCLA School of Dentistry. The research study will compare saliva and plasma samples from NSCLC patients to identify usctDNA molecules in saliva and use special extraction methods to improve overall sensitivity of current liquid biopsy procedures. Press release.
Variantyx is launching its Genomic Unity Prenatal Analysis test, applying the same comprehensive testing approach that it has used successfully in pediatric and adult settings to high-risk pregnancies where ultrasound anomalies have been identified. Variantyx pairs the patient’s complete DNA sequence with proprietary data analysis algorithms and phenotype-driven filters to uniquely identify and definitively report on all major types of genetic variation within a single assay. Including genome-wide small sequence changes, structural variants, mitochondrial variants and tandem repeat expansions. The test is performed using amniotic fluid paired with blood from both parents to provide an accurate and comprehensive genomic analysis of the fetus. Press release.
The American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), National Hemophilia Foundation (NHF), and World Federation of Hemophilia (WFH) have developed joint clinical practice guidelines on the diagnosis and management of von Willebrand Disease (VWD), the world's most common inherited bleeding disorder. The guidelines were published in Blood Advances. Guidelines.
Babson Diagnostics says it will change diagnostic blood testing using small fingertip samples less than one-tenth the volume of venipuncture that do not sacrifice quality, accuracy, or menu breadth. Babson will deploy its proprietary technological ecosystem at accessible retail locations such as pharmacy counters throughout the country, giving customers the benefit of longer hours of operation, low out-of-pocket costs, and a more human experience. Babson Diagnostics' technological ecosystem innovates on all three steps of the diagnostic blood testing process. A next-generation capillary collection device, developed in partnership with BD (Becton, Dickinson and Company), is designed to be used by any trained healthcare worker, such as a pharmacy technician, rather than requiring a certified phlebotomist. The healthcare worker then places the collected capillary sample in Babson’s proprietary sample preparation device, which is compact and designed to fully automate all preanalytical processes, rather than requiring manual sample handling. Babson couriers will retrieve the processed samples daily and deliver them to Babson’s CLIA-certified, high-complexity microsample laboratories, where they are analyzed using Babson’s proprietary miniaturized assays. This new approach realizes both the accessibility and convenience of sample collection at retail settings and the menu breadth, quality, and efficiency of centralized analysis. Press release.
EpiVario has entered into an option agreement with the University of Pennsylvania for an epigenetic marker that could potentially be targeted to develop drug treatments for early-stage Alzheimer's disease therapy. Under the terms of the agreement, EpiVario holds the first option to negotiate an exclusive license agreement for this Penn-owned technology, which was featured in a September 2020 study published by Nature Genetics. The study suggested that a reconfiguration of the epigenomic landscape occurs with Alzheimer’s disease, with certain marks impacting disease pathways by disrupting feedback loops between genes and chromatin. Over the next year, EpiVario will seek to identify modulators that could potentially limit the activity of these epigenetic regulators to prevent Alzheimer’s disease. In addition to entering into the option agreement with Penn, EpiVario has also announced that it has closed its Seed Funding round with a new investment of $112,500, bringing the total outside investment to $717,000. The additional funds will be used to advance the Company’s addiction therapy research, as well as explore endeavors in the area of memory-related disorders. Press release.
Resolution Bioscience has announced a companion diagnostic agreement with Mirati Therapeutics. As part of the agreement, Resolution’s ctDx liquid biopsy technology will be used to help identify non-small cell lung cancer (NSCLC) patients who may benefit from Mirati’s investigational KRAS G12C inhibitor therapy. The fast and non-invasive assay was designed to detect actionable NSCLC mutations, such as KRAS G12C. Mirati’s investigational drug candidate adagrasib (MRTX849) is an orally available small molecule that potently and selectively inhibits the G12C substitution mutation. The Resolution assay will be used to identify patients whose cancers are driven by this KRAS variant. Press release.
Nuvo Group has filed a 510(k) notice with the U.S. Food and Drug Administration (FDA) to add a new uterine activity module that provides capability for remote monitoring of maternal uterine activity (MUA). INVU has already received FDA clearance for remote monitoring and measurement of fetal and maternal heart rates. By measuring MUA, INVU will enable providers to recognize uterine contractions in women who are being monitored at home. If cleared by the FDA for this indication, INVU will provide a passive, non-invasive alternative to the current standard of care for MUA measurement. Press release.