Learn about this year's contestants and their disruptive technologies.
Babson Diagnostics | BetterWay Blood Testing Service
Dionysus Digital Health, Inc. | The Enlighten Test
Meliolabs Inc. | MeltStat
Mercy BioAnalytics, Inc. | Mercy Halo™ Ovarian Cancer Screening Test
PBD Biotech, Ltd | Actiphage TB Blood Test
Vitestro | Vitestro autonomous blood drawing device
babsondx.com
BetterWay Blood Testing Service
Babson Diagnostics is a science-first healthcare technology company reimagining the entire diagnostic blood testing experience. Babson's mission is to make routine blood testing less invasive, more convenient, and affordable while empowering people to take charge of their health.
Babson is preparing for the commercial launch of BetterWay™ blood testing in the summer of 2024, a first-of-its-kind ecosystem designed for primary care and family medicine, supporting annual exams, chronic condition management, and screenings. BetterWay is designed to expand access to blood testing by using a pea-sized amount of blood collected from a fingertip by trained healthcare professionals in convenient locations without the need for a phlebotomist. The BetterWay menu will cover the most ordered tests with high-quality results equivalent to traditional methods of blood testing that require much more sample volume.
The company has received key patents in the United States, European Union, and China related to its unique end-to-end technological ecosystem and the ability to maximize the clinical utility of microsamples of blood collected from a fingertip. In addition, Babson’s commercial launch will include a full validation of a broad set of miniaturized assays that are ready for commercial use in its CLIA-certified laboratory.
Babson, based in Austin, Texas, is led by individuals with deep experience in healthcare, diagnostics, engineering, and laboratory technologies. The company is named in honor of Art Babson, whose legacy of scientific innovation and excellence is the foundation on which the company is built.
Seventy per cent of medical decisions depend on laboratory test results, yet 40% of people report skipping their routine bloodwork (due to collection, accessibility, convenience and experience). BetterWay is a blood testing service developed by Babson Diagnostics, Inc. and validated for clinical use in routine blood testing in the United States. It is a consumer-friendly finger collection blood testing experience using novel capillary collection that requires only one-tenth the sample volume of conventional venipuncture, highly accessible at convenient retail locations, such as pharmacies, and delivers medically accurate results. BetterWay Blood Testing service includes innovation in collection (BD MiniDraw™ Capillary Blood Collection System developed with Babson and BD), sample preparation and analysis. BetterWay will offer a broad menu of the most commonly ordered lab tests for routine care and meet the needs of primary care practitioners as well as consumers who wish to order their own laboratory tests.
dionysushealth.com
The Enlighten Test
Dionysus is a start-up phase company focused on developing a family of products that combine innovations in software, AI based analysis and neurobiology to improve human neurobiological health. Our technology platform and technical approach builds upon new insights from our scientific founders that is based on an improved understanding of neurobiological circuits that underpin gender related behaviors, and commonly associated mood disturbances. Direct integration of these neuroinformatic insights through AI based analysis of quantitative behavioral assessments, and genetic and epigenetic mapping, provides new opportunities to better diagnose, treat and monitor mood disturbances, and provides direct insights into how to develop and direct more effective treatments, and prevent disease progression
We are developing a platform of proprietary epigenetic tests to predict the risk of hormonal depressions like postpartum depression (PPD) and related mood disorders associated with PMS and menopause in women. A key technological innovation that differentiates Dionysus from other systems is the integration of our epigenetic testing platform with a companion smart phone-based App which can assess perceived stress and anxiety, and track mood swings, based on discussions with a proprietary large language model. The result is a platform technology with broad applicability, and high impact across multiple high value markets including mental health care, wellness, and healthy aging.
melio.tech
MeltStat
Melio aims to transform bloodstream infection testing and in doing so, improve diagnostics, treatment and quality of life for patients around the world. A cutting edge solution was created to answer a need across several areas of medicine: to limit unnecessary prescription of antimicrobials, improve diagnostic accuracy, reduce the time to appropriate treatment, and become a useful tool in the fight against global antibiotic resistance.
Melio is developing a culture-free direct-from-blood diagnostic to detect hundreds of pathogens all at once. The patent-protected system integrates multiple microfluidic techniques for blood separation and genetic analysis in a disposable device that reliably identifies clinically relevant pathogens in 3 hours from whole blood patient samples (slide 1). Building on the foundational work at UC San Diego by co-founders, Melio’s inventive core team with a combined 100+ issued patents is exploiting its proprietary technology with AI-enabled single-cell DNA melt curve analysis to create the first of its kind point-of-care culture-free microbial testing platform.
Our patented innovation sits at the intersection of single-cell analysis and ultra high-resolution melting and enables our first-of-its-kind diagnostic that can deploy new pathogen detection capabilities with simple software updates. This means our product can respond to new pathogens without needing to manufacture and distribute new reagents across healthcare settings and borders. Our initial product targets the top 12 bacterial and fungal pathogens and resistance markers. Our primary clinical focus on neonates will transform the way we treat almost 10% of all newborns and eliminate 99% of unnecessary antibiotic use at birth.
Melio overturns the traditional one-pathogen one-probe paradigm for infectious disease tests, and overcomes the fundamental tradeoffs between rapid testing and the number of pathogens existing technologies can identify. Melio offers rapid (3h) comprehensive culture-free ‘direct from blood’ testing to 1) rule-in infections to initiate timely targeted treatment and 2) rule-out bloodstream infections with high confidence, obviating harmful antibiotic overuse. Melio’s first offering targets a low-cost instrument (Target ASP < $15K) with high margin consumables (Target ASP $150). Melio integrates AI-enabled long read DNA melting with digital single cell analysis and acoustophoretic sample preparation to interrogate intact pathogen cells with minimal interference from blood and contaminating DNA in a single test that allows for:
mercybio.com
Mercy Halo™ Ovarian Cancer Screening Test
Mercy BioAnalytics’ mission is to relieve suffering and save lives through the early detection of cancer. The company was founded in 2018 on the principle that colocalized biomarkers on individual extracellular vesicles (EVs) offer a unique and underexplored opportunity to achieve ultra-high sensitivity and specificity for early-stage cancer. While there are many companies pursuing early cancer detection, to our knowledge, no other company has pursued this method of profiling EVs for cancer screening.
Early-stage cancer is difficult to detect, but when found, is more often amenable to curative therapy. The patented Mercy Halo™ liquid biopsy platform utilizes biomarker colocalization to interrogate highly abundant, blood-based extracellular vesicles that carry unique cancer signatures from their parent cells. The Mercy Halo platform is designed to detect Stage I cancer when it is most treatable to enhance the quality of life for cancer patients and their families. Mercy’s initial focus is the early detection of ovarian and lung cancers. Ovarian cancer, the most lethal gynecological cancer, typically goes undetected until it is too late to cure. Lung cancer, the number-one cancer killer, takes more lives than breast and prostate cancers combined.
The company currently has 35 employees and is located in Waltham, MA. The most recent financing round raised $41M (Series A, March 2023) and was led by Novalis LifeSciences, with participation from Sozo Ventures, Hatteras Venture Partners, iSelect Fund, American Cancer Society BrightEdge, and Broadway Angels. It also included strategic investments from LabCorp and Bruker, in addition to strong participation from previous investors.
Mercy's patented technology enables the highly sensitive and specific detection of cancer at its earliest stages through measurement of surface associated tumor-derived extracellular vesicles, which exist at high abundance in circulation. This technology allows the development of low cost, high performing cancer screening tests that will be broadly accessible, filling a critical gap in helping to detect cancer early when it is the most curable. Our leading program, the blood-based Mercy Halo™ Ovarian Cancer Test (OC Test), represents the first major advance in ovarian cancer screening in 40 years, delivering superior performance to currently available technologies. Ovarian cancer is the 6th leading cause of cancer death in US women (8th worldwide), in large part due to its frequent late state at diagnosis. A broadly available, low-cost, high performing blood test implemented in an annual screening program can save lives by identifying ovarian cancer early when it is most treatable.
pbdbio.com
Actiphage TB Blood Test
PBD Biotech are developers of the Actiphage TB Blood Test. Our mission is to support the scale-up of global test-and-treat campaigns with Actiphage to achieve the goals of the WHO End TB strategy. Leveraging Actiphage’s unique role in detecting active TB, PBD Biotech aims to drive innovation in the novel uses for TB screening and drug management. PBD Biotech uses a technology platform-based commercialization business model for Actiphage. We are focused on scientific development, manufacturing, and distribution. Our global commercial strategy is to maximize Actiphage’s utility and scalability across LTBI screening and TB drug management. We plan to make Actiphage. IVD platform agnostic to maximize Actiphage test availability. We invest in global market education and awareness, for market preparation of Actiphage technology.
Actiphage® TB Blood Test (Actiphage®) is the only test that combines phage technology to detect only active, disease-causing mycobacteria (Mtb) with traditional qPCR methods, resulting in a highly specific and sensitive novel diagnostic assay. Actiphage disrupts the global landscape of TB diagnostics by offering a superior alternative to existing culture-based, molecular, and IGRA test methods. Actiphage addresses key limitations of current diagnostic methods, potentially transforming how TB is diagnosed and managed globally. Actiphage will be the first TB diagnostic to “rule-in” TB drug and vaccine treatment as a “test for disease progression” and offer a TB drug treatment “test-of-cure.” Actiphage has the potential to reduce global TB morbidity, mortality, and transmission. It supports public health efforts to control TB by facilitating timely treatment, shortening drug treatment regimens, and preventing further spread of the disease. Actiphage was a “Top Scientific Finding” at the 2022 32nd ECCMID congress.
vitestro.com
Vitestro autonomous blood drawing device
Vitestro, a leading Dutch medical robotics pioneer, was founded in 2017 after the founders personally experienced challenges in getting blood drawn. They then started the journey to develop a device for improved blood draws through autonomous phlebotomy (venous blood drawing) in patients. The company is now in the final stages of product development of the device. Vitestro has a passionate and experienced multidisciplinary team of 60+ specialists with expertise in AI, robotics, image recognition, medical software engineering, clinical and regulatory affairs, and commercialization. Together, this team tackles tough challenges to find the most cutting-edge solutions of our era. Vitestro is supported by Silicon Valley-based Sonder Capital. Sonder Capital is led by veterans of the medical technology field with decades of experience as founders, operators, and investors.The premise for this innovation is to create a safe and consistent patient experience parallel to working towards a positive impact on solving the increasing shortage of healthcare personnel. The device enables total automation of the preanalytical phase, standardizing the highly variable phlebotomy procedure.
Vitestro has collaborated closely with leading European hospitals and clinical laboratories during design and development. This year, 10,000 patients will participate in the world’s largest trial on autonomous phlebotomy (ADOPT Trial - Autonomous Blood Drawing Optimization and Performance Testing). The company expects to launch its autonomous phlebotomy technology this year in Europe.
Over 13 billion laboratory tests are performed yearly in the United States, impacting 70% of clinical decisions. Despite their pivotal role, clinical laboratories now face a workforce crisis that endangers access to care. Vitestro, a Dutch medical robotics company, has developed an autonomous phlebotomy device to bring end-to-end automation to phlebotomy departments. The breakthrough device uses AI-based ultrasound technology and proprietary robotics to collect high-quality specimens automatically. One healthcare professional can supervise multiple devices (and thus patients) simultaneously, significantly reducing the required staffing. Considering phlebotomy takes up 1/3 of a lab’s workforce, end-to-end automation is expected to greatly improve overall impact patient care. The device has been tested in thousands of patients, with a 98% patient acceptance rate. It fills a clear market need, demonstrated by commercial agreements with leading European hospitals. Product launch is anticipated for 2024 in Europe and 2026 in the U.S.
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