November 25, 2024 | NOWDiagnostics announced that its First To Know Syphilis Test, a key tool in syphilis prevention, is available for purchase nationwide; Veravas announced the results of an analytical verification study of its VeraBIND Tau assay, a next-generation test being co-developed with Phanes Biotech for the detection of Alzheimer’s disease at its earliest, most treatable stages; and more.
NOWDiagnostics announced that its First To Know Syphilis Test, a key tool in syphilis prevention, is available for purchase nationwide. The first-of-its-kind, self-directed rapid test provides in-home results in 15 minutes with as little as a drop of blood, offering individuals an accurate, easy-to-use, and private way to test for syphilis. First To Know is the only syphilis test in the U.S. with FDA marketing authorization for OTC use, and it can now be purchased online at Amazon and in thousands of major retail, pharmacy, and drugstore locations across all 50 states. Press release.
Veravas announced the results of an analytical verification study of its VeraBIND Tau assay, a next-generation test being co-developed with Phanes Biotech for the detection of Alzheimer’s disease (AD). The test is designed to detect and measure disease pathology to enable the diagnosis of AD at its earliest, most treatable stages. VeraBIND Tau is designed to detect active disease by studying measurable binding activity occurring in the brain between hyperphosphorylated tau (HPT) and normal tau (nTau), which is a hallmark of AD. The test can also aid in the diagnosis of AD, giving clinicians an accessible, accurate, and affordable alternative to tau PET imaging. Press release.
GeneDx announced GeneDx Discover, a first-of-its-kind data visualization tool, which provides biopharmaceutical companies access to deidentified and aggregated genetic data—powered by GeneDx’s database—to improve all stages of drug development. The new offering is part of GeneDx’s ongoing investment to deliver personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. GeneDx Discover is a self-service tool that leverages real-world data to enable a deeper understanding of the characteristics of target patient populations. The tool combines disease prevalence and phenotypic information, alongside variant-level details, unlocking a better understanding of the size and unique characteristics of the total addressable market for genetically-defined disease cohorts, as well as obtaining variant-level resolution to define the cohort. Press release.
Sheba Medical Center's innovation arm, Accelerate, Redesign, and Collaborate (ARC), has partnered with Roche to advance the diagnosis and treatment of non-small cell lung cancer (NSCLC) by leveraging AI. This collaboration aims to integrate AI with digital pathology tools to enhance the speed and accuracy of NSCLC diagnostics. The goal is to improve the detection of molecular markers in NSCLC, which is expected to lead to faster and more precise detection of patients suitable for targeted treatments and immunotherapies. Press release.
FLUXERGY announced that it is the first company to use in-kind Diagnostics Development Services from the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) to advance molecular testing and sample preparation capabilities on the Fluxergy Platform. Under NIAID's suite of preclinical services, NIAID-funded contractors will evaluate rapid nucleic acid extraction and purification methods compatible with the Fluxergy Test Card, with the goal of achieving high sensitivity, sample-to-answer molecular tests to be developed for gram-negative and fungal pathogens that cause sexually transmitted infections and bacterial and fungal vaginosis. These integrated extraction capabilities will be required for the development of Fluxergy's sexually transmitted infection (STI) test and comprehensive vaginosis test. Press release.
A study led by researchers at the University of Gothenburg, Sweden, is paving the way for a new approach that could soon make Alzheimer’s testing more accessible worldwide. A quick finger prick and a few drops of blood on a card can be sent in regular mail. The biomarkers measured in this test have been developed over a long period and have shown strong performance—initially in cerebrospinal fluid, then in venous blood samples, and now in blood from superficial vessels in the finger. Scientific abstract.
Detection Technology unveiled a comprehensive portfolio of flat panel X-ray detectors to advance medical imaging. This unique medical flat panel lineup includes 20 solutions that combine high frame rates with exceptional image quality at low doses and a wide dynamic range. The newly enhanced portfolio is optimized for a range of medical applications, including image-guided surgery, wireless radiography, fluoroscopy, oncology, and dental imaging. Press release.
Exagen announced the validation and regulatory submission for approval of new Systemic Lupus Erythematosus (SLE) and rheumatoid arthritis (RA) biomarkers, to be incorporated into the AVISE CTD platform. Collectively, these new biomarkers will further improve the clinical utility of AVISE CTD, providing clinicians with the information they need to definitively diagnose patients and shorten their autoimmune diagnostic journeys. Press release.
Capitainer announced the establishment of an expansion in the U.S. named Capitainer Inc. This expansion will enhance customer service and streamline order processing for the company’s growing U.S. market, further strengthening Capitainer’s goal to become the global leader in self-sampling. As of September 1, all U.S. orders will be processed through Capitainer Inc., enabling the company to provide faster, more tailored service to North American clients. Capitainer’s expanded U.S. presence will improve delivery times, offer local support, and allow for better responsiveness to market needs. Press release.
Brook Health and Linus Health announced a collaboration that allows patients to be screened, assessed, and sent home with a treatment plan for cognitive issues on the same day, backed by direct access to a 24/7 remote clinical care team. Combining Linus Health's advanced digital cognitive assessment tools with Brook Health's remote care platform, the collaboration will provide primary care physicians a way to make early detection of mild cognitive impairment (MCI), a precursor of dementia, as routine as any other preventive screening. Press release.
Lucent Diagnostics has introduced LucentAD Complete, a new multi-marker blood test designed to help detect Alzheimer’s Disease (AD) in a broader range of patients. Recent Alzheimer’s Association criteria for diagnosing AD leaves an “intermediate zone” of uncertainty, requiring patients that fall into this zone follow up with cerebral spinal fluid measurement via invasive lumbar puncture or costly amyloid PET scans. LucentAD Complete addresses this by reducing the number of patients that fall into the intermediate zone by threefold. The test uses a proprietary algorithm to score five AD-related biomarkers (p-Tau 217, Aβ42/40, NfL, GFAP) providing significantly better amyloid classification compared to single-marker tests alone. Press release.
BARDA and Sherlock Biosciences entered a partnership to develop the Sherlock Molecular COVID-19 + Flu A + B Test, a home-use, molecular test designed to use isothermal amplification to detect and differentiate SARS-CoV-2, influenza A, and influenza B viruses. The device is hand-held, single-use, battery-operated, and is expected to provide results in 15 minutes. Samples are collected from nasal swabs from individuals with symptoms of a respiratory infection. This effort is part of BARDA’s 2022-2026 Strategic Plan, which emphasizes the importance of evaluating home-use, laboratory, and point-of-care testing that can be rapidly adapted to emerging threats. Press release.