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pattern.bio
Single Cell Microbiology
Pattern Bioscience aims to save lives by transforming how bacterial infections are diagnosed and to improve global health by reducing the burden of antibiotic resistance. Its technology is the first and only culture-free, rapid phenotypic testing platform to deliver clinically actionable results in a timeframe that will enable healthcare teams to get appropriate, life-saving treatments to patients fast enough to make a real difference in outcomes. The company’s first tests will be for critically ill patients with pneumonia and bacteremia, identifying both the causal pathogen and its antibiotic susceptibility profile in just four to six hours, compared with the days required for traditional culture testing. Pattern Bioscience is a privately held company based in Austin, Texas, led by veterans of the diagnostic industry with deep experience bringing new diagnostic technology to market.
Pattern Bioscience has developed a new type of culture-free test that can quickly identify the pathogen causing an infection and determine its susceptibility to antibiotics. The test uses a combination of single-cell analysis and AI to directly measure the response of individual bacterial cells to antibiotics, which helps healthcare teams make informed decisions on antimicrobial therapy. In contrast to PCR or sequence-based methods, which measure genetic targets associated with resistance, Pattern’s technology directly measures the response of bacterial cells to antibiotics to rule-in exactly which agents can be used for therapy; just like the standard-of-care culture methods, but an order of magnitude faster.
Pattern’s single cell microbiology technology is capable of testing directly from complex clinical specimens, including non-sterile body sites where pathogens often mix with normal microbiota. Pattern’s unique capability to test directly from polymicrobial specimens results from our approach to single-cell isolation. Our technology bypasses the traditional agar plate-based colony isolation process by encapsulating single bacterial cells (or colony-forming units) in individual, isolated, picoliter-volume “culture droplets,” creating an array of single-cell isolates. This crucial step separates the antibiotic response of each type of bacteria in the sample, enabling Pattern to deconvolve the antibiotic susceptibilities of multiple bacterial species. Accordingly, Pattern’s technology is the first and only emerging technology that can comprehensively diagnose pneumonia directly from a clinical specimen and, as such, Pattern’s Pneumonia ID/AST Panel was granted Breakthrough Device Designation from the FDA.
mspentechnologies.com
Product/Technology
MasSpec Pen
Organization Description
MS Pen Technologies, Inc. is an innovative medical technology company commercializing AI-powered tissue diagnostic devices that deliver real-time molecular information at the point of need to optimize diagnostic decisions, surgical intervention, and treatment options for patients. Our mission is to enable surgeons and clinicians with real-time, molecular data that drive better patient outcomes. We envision a future of healthcare in which biological data is made available at the point of need to identify diseases early so patients can be treated quickly and effectively.
MS Pen is addressing the critical deficiencies in diagnostic and surgical pathology by commercializing innovative medical mass spectrometry-based diagnostic products for medical research and clinical use, based on our proprietary MasSpec Pen technology. Our research product, called Uniss – universal sensing system – is a research use only system that can be integrated to any existing mass spectrometer currently deployed in research and clinical laboratories for rapid and direct molecular analysis of clinical samples. Our medical product, called UltissTM – the ultimate surgical sensing system – is a medical platform that like no other technology combines the simplicity and ingenuity of the MasSpec Pen device with the unparalleled performance of a high-resolution mass spectrometer and AI-powered software into a single integrated system to deliver real-time diagnostic decisions at the point of need.
Product/Technology Summary
Mass spectrometry (MS) is the gold-standard analytical measurement technology for laboratory-based molecular analysis. MS identifies sample components based on their atomic and molecular mass. MS is well-known for its ability to provide detailed analysis of a wide variety of samples with unparalleled sensitivity and specificity -- from small molecules (e.g., metabolites and drugs) to large proteins (e.g., antibodies). Although MS is an extremely powerful analytical tool, traditional sample preparation methods are laborious and time consuming. Further, conventional MS instruments are large, expensive, and complex to operate, which has limited adoption. It is this traditional form of MS that we aim to disrupt by creating and deploying the Uniss and the Ultiss systems – pioneering MS platforms tailored for research and medical users.
Our core technology, the MasSpec PenTM, is a proprietary device that is used to directly analyze tissue and other samples in seconds. Based on a “touch and tell” approach, the device, designed as a handheld or a minimally invasive probe, is a simple yet revolutionary interface between the non-expert user and a sophisticated mass spectrometer. The ingenuity of the MasSpec Pen is what enables us to bring the power of molecular analysis by MS to the broadest user base possible - opening new market opportunities including disruptive applications in clinical and medical diagnostics. Our products are intuitive systems that are simple to operate, delivering molecular results instantaneously.
(Audience Choice)
vitalbio.com
VitalOne
Vital is a team of scientists and engineers who are passionate about disrupting healthcare. We started as a group of classically-trained research scientists from top institutions (Harvard, Scripps, Berkeley, UWaterloo, UToronto) and took a beginners’ mindset approach, taking nothing for granted and considering naivety as an advantage rather than a bug. We built a system from the ground up, learning all the painful lessons first hand and earning the right to recruit industry veterans that have successfully launched products at Abbott, Roche, Siemens, Luminex, Abaxis, Laborie, Invetech, Terumo, Genmark, Ilumina, IDEX, and Quanterix. Together we blend the advantages of unencumbered innovation with tried and true practices to build the product that is best for patients and physicians.
We aim to make health information universal by physically bringing diagnostics to the point of care. Early and timely diagnostics will make care more informed, personalized, and proactive. Our platform will enable rapid results with incredibly small blood volumes. Our technology enables automation and form factors that are accessible outside of centralized labs to reconnect diagnostics and treatment.
We built a strong network of practicing physicians and Chief Medical Officers from world-class institutions who help guide our thinking on clinical utility and medical necessity. Additionally, some of our key employees were previously practicing physicians who help maintain that perspective in our everyday work.
Vital Biosciences is headquartered in Canada and has a US subsidiary that employs approximately a dozen people. Its co-founders had previously established the diagnostic companies Elucid Labs and Confer Health.
At Vital, we’re building a single automated device to truly bring a full suite of diagnostics to wherever patients are. Our technology aims to make healthcare radically more personalized, proactive, and accessible.
With 600 uL of blood, our platform quantifies 50+ of the most commonly requisitioned biomarkers in primary care in 20 minutes, without compromising on analytical performance. Using an automated microfluidic workflow, the instrument will run three subsystems in parallel: hematology, clinical chemistry, and immunoassays. The platform will quantify the full panel of biomarkers using on-board optical readers and automated sample preparation and measurement procedures that require minimum user input. These qualities make the platform suited for use in CLIA-waived settings.
Our initial menu spans a wide range of potential use cases for the general population, including inflammation, cardiac markers, diabetes, liver disorders, lipid disorders, post acute event monitoring, clinical trial monitoring, chronic disease management, and proactive lifestyle management.
We are building a menu so comprehensive that it covers 100% of tests needed for at least 90% of patients, eliminating the need to send any tests out to a centralized lab. There would be no need for patients to travel to a draw site or ship their sample to a centralized laboratory, forcing them to wait for days to discuss their results with their healthcare provider. Patients likely to need bloodwork can provide their sample at check-in and receive results during their original appointment. Closing this care gap makes diagnostics more accessible and accelerates clinical decision making.
cardiodiagnosticsinc.com
Epi+Gen CHD
Cardio Diagnostics is a precision cardiovascular diagnostics company that makes cardiovascular disease prevention and early detection more accessible, personalized, and precise. The company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for enabling improved prevention, early detection, and assisting in the treatment of cardiovascular disease.
Epi+Gen CHD is an integrated epigenetic-genetic test for three-year symptomatic coronary heart disease risk assessment, the most common type of heart disease and the primary cause of heart attacks. This highly sensitive and accessible test profiles a panel of genetic and epigenetic biomarkers, is radiation-free, does not require fasting, and can be conducted remotely or in provider settings.
Epi+Gen CHD is the only epigenetics-based and near-term risk assessment test for CHD. Competitive products include lipid-based Framingham Risk Score and ASCVD Pooled Cohort Equation, assessing 10-year risk for cardiovascular disease. Because the test evaluates objective genetic and epigenetic biomarkers, it avoids the pitfalls associated with the current lipid-based risk calculators.
This test should be considered for this award because it transforms how we think about and approach cardiovascular disease. Before Epi+Gen CHD, heart disease risk was assessed using lipid-based risk calculators, simple linear regressions and now, instead of relying patient reported history, or proxy biomarkers like cholesterol levels to determine heart disease risk, we have molecular heart disease risk assessments that look at specific epigenetic and genetic biomarkers combined with artificial intelligence to provide objective and personalized and precise information about a specific patient’s future heart disease development.
uclaliquidbiopsy.org
Eximius Liver Cancer Test
Eximius Diagnostics (Dx) is a cutting-edge liquid biopsy diagnostic company that specializes in developing innovative platform technologies for the purification and characterization of tumor-derived extracellular vesicles (EVs) from serum and plasma. The company spun out of UCLA and has established clinical partnerships with UCLA Health and Cedars Sinai Medical Center. Co-founders Professors Hsian-Rong Tseng and Yazhen Zhu also co-direct UCLA's Liquid Biopsy Laboratory. With the continuous support of NIH funding for the past decade, Eximius Dx’s team has developed a series of IVD technologies that can process blood samples to purify and characterize tumor EVs. In October 2022, Eximius Dx closed a seed round of financing and is currently raising its Series A. The company is headquartered in Los Angeles, at Magnify, an incubator space located in the California NanoSystems Institute on the UCLA campus.
Eximius Dx's noninvasive tests offer actionable solutions that improve the clinical management of various solid tumors. By identifying unmet needs and challenges in oncology, the company provides unique Dx solutions that help cancer patients and physicians chart a clearer path forward. The company's first clinical-stage test is Eximius Liver Cancer Test, an in vitro diagnostic (IVD) test that detects hepatocellular carcinoma (HCC) using human plasma samples collected from at-risk liver cirrhotic patients. Eximius Liver Cancer Test uses qPCR technology to quantify HCC EVs, enabling early-stage (Stage 0-A) HCC detection. When used in conjunction with liver ultrasound, Eximius Liver Cancer Test is intended to aid in the detection of HCC.
HCC is a leading cause of cancer-related death globally, with over 30,000 deaths expected in the US in 2021. Early detection of HCC is crucial for improved patient prognosis. Eximius Dx has developed a non-invasive EV-based IVD test for HCC, which overcomes the limitations of existing alternatives, such as poor performance and the need for large volumes of blood, long turnaround times, high cost, and centralized operation. Eximius Liver Cancer Test detects and quantifies HCC EVs using <1-mL plasma/serum in a 2-hour workflow. Eximius Dx conducted a phase-2 biomarker study to validate the performance of the test for early HCC detection, and results were published in Hepatology in August 2022. The FDA granted Eximius Liver Cancer Test the Breakthrough Device Designation in December 2022 to expedite its approval pathway, and its adoption can be cost-efficient and widespread due to the deployment of qPCR machines during the COVID-19 era.
micronoma.com
Oncobiota™, including OncobiotaLUNG
Micronoma is the first cancer-detection company utilizing signals from blood-circulating microbial nucleic acids to diagnose cancer at an early stage with minimally invasive, microbiome-driven liquid biopsy technology.
Micronoma’s founders turned the cancer diagnosis field upside down when they discovered this method, which was published in Nature in 2020. The research established that virtually all cancers are not sterile and each cancer type has a unique microbial community, which is detectable in human blood, thereby establishing a new class of cancer diagnostics, using circulating microbiome information.
Micronoma has focused first on building a novel, early-stage lung cancer diagnostic, OncobiotaLUNG, which recently received FDA Breakthrough Designation status, and will be launching later in 2023. Micronoma is focusing on lung cancer diagnosis initially since it is among the most prevalent and deadly cancers. Other cancer types that are in the pipeline include pancreatic, ovarian, breast, colorectal, and liver, to name a few.
The deep expertise of the Micronoma team and its pioneering role in microbiome science and oncology--combined with the power of machine learning and bioinformatics--mobilizes the outstanding potential of this innovative technology to improve earlier cancer diagnosis, and could potentially prevent millions of cancer deaths per year.
We have a line of sight on powerful new solutions that we think could revolutionize the standard of care for lung cancer at many levels: patient survival rates, access to minimally invasive tools for physicians, and reducing healthcare system costs, primarily by reducing the instances of costly tissue biopsies.
Not long ago, blood was thought to be free of microbes unless a patient was septic. The discovery by Micronoma’s founders (Nature 2020) established that virtually all cancers are not sterile and each cancer type has a unique microbial community, which is detectable in human blood. Micronoma is the first company developing a platform using these microbial markers in tissue and blood, thereby establishing a new class of cancer diagnostics, using circulating microbiome information.
Importantly, these microbial signals do not seem to be dependent on tumor size, increasing the likelihood our proprietary platform can detect cancer at an earlier stage (stages I and II) of cancer development than other methods. Micronoma is starting with lung cancer, since it is among the most prevalent and deadliest of cancers.
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