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www.dayzerodiagnostics.com
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Product/Technology
DZD OneSeq Dx
Organization Description
Day Zero Diagnostics, Inc. (DZD) is an early stage, deep tech company based out of Boston, MA. We are developing a new class of in vitro diagnostics (IVD) capable of quickly and comprehensively diagnosing severe infections, including their antibiotic susceptibility profiles. The company was founded by a team of clinicians, scientists, and entrepreneurs from Massachusetts General Hospital, Harvard, and the Massachusetts Institute of Technology who were frustrated and shocked by the utter lack of actionable diagnostic information available early on for patients with life threatening infections. In an era of personalized medicine, it seemed unconscionable. We saw an opportunity to take advantage of the rapid pace of evolution in sequencing technology and costs to build a modern, genomic data-based approach to infectious disease diagnostics.
Today, the company has over 35 employees focused on the development of proprietary sample preparation technologies and IVD engineering, as well as advanced artificial intelligence-based algorithms for organism ID, antimicrobial resistance profiling, and hospital outbreak detection. Our goal is to shift the hospital diagnostic workflow from a reliance on analog, culture-based technologies to a digital, sequencing-based approach to improve patient care and reduce healthcare costs.
Product/Technology Summary
Day Zero Diagnostics (DZD) has developed a set of groundbreaking technologies that enable the use of whole genome sequencing to rapidly, accurately, and cost-effectively diagnose infections directly from clinical samples without the need for culture growth.
The first application is for bloodstream infections and sepsis, an area of enormous unmet clinical and economic need. The life expectancy of a patient with septic shock is 24 hours without fast effective antibiotic treatment. However, current diagnostics fail to provide a diagnosis in 40% of cases and even when they do, it can take 2-5 days to identify the pathogen and provide its antibiotic susceptibility profile.
Without a way to accurately diagnose an infection early, physicians are forced to “carpet bomb” patients with a cocktail of powerful, yet toxic, broad-spectrum antibiotics. This strategy exposes sick patients to excess toxicity, can lead to significant morbidity and mortality, and is still ineffective in 30% of cases due to the rise of antibiotic resistant organisms.
At DZD, we have developed a set of breakthrough capabilities that can provide a complete diagnosis, including both the species ID and antibiotic susceptibility profile, in hours vs. days. Our technology enables the unprecedented recovery of pathogen whole genome sequences directly from clinical samples that may contain up to a billion times more human DNA. Our algorithms then interpret the genomic data to provide accurate, comprehensive organism ID and antibiotic susceptibility profiles. DZD enables a targeted treatment on day zero of hospital admission, resulting in better patient outcomes and cost savings.
Mammoth.bio
DETECTR
Mammoth Biosciences, Inc. is harnessing the diversity of nature to power the next generation of CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. By leveraging its internal research and development and exclusive licensing to patents related to Cas12, Cas13, Cas14, and CasΦ, Mammoth Biosciences can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense, and more. Based in Brisbane, California, Mammoth Biosciences is co-founded by Nobel Prize winner and CRISPR pioneer Jennifer Doudna as well as Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Decheng, Mayfield, NFX, and 8VC, and leading individual investors including Brook Byers, Tim Cook, and Jeff Huber.
The COVID-19 pandemic has shed light on the urgent need for high quality diagnostic tools that provide both rapid and accurate results. Traditional molecular diagnostics offers the highest performance, but it traditionally requires large, expensive laboratory machines and trained technicians to operate. Lateral flow-based diagnostics offer a low-cost, decentralized, and scalable option that can be administered closer to the patient, but they lack the performance capability needed for high accuracy.
Mammoth Biosciences catalyzed a new approach to molecular diagnostics, called DETECTR. Based on CRISPR, this programmable platform acts as a search engine for biology and is capable of finding and identifying any nucleic acid sequence in the genome.
Using proprietary technology licensed exclusively from the University of California, Berkeley and developed internally, Mammoth is working on multiple form factors and test targets from infectious diseases to cancer. For example, DETECTR was configured in less than two weeks to detect SARS-CoV-2, demonstrating the platform’s ability to be quickly tailored to identify any DNA or RNA target. The resulting product, DETECTR BOOST, is a reagent kit that when combined with standard laboratory automation provides labs with unparalleled high throughput molecular testing.
Me-Med.com
MeMed COVID-19 Severity
At MeMed, a leader in host response technologies, we decode the body’s complex signals into simple insights that improve people’s lives. By leveraging our expertise in host-response profiling and machine-learning algorithms, we are creating a portfolio of tests that address tough clinical dilemmas. Importantly, with the support of public and private partnerships, we have developed a point-of-need, rapid measurement platform called MeMed Key to ensure timely availability of these novel tests during the clinician’s decision-making workflow.
Our lead product, MeMed BV, accurately differentiates bacterial from viral (BV) infection, enabling improved patient management, including appropriate antibiotic use, in order to help address the global healthcare challenge of antimicrobial resistance. Based on computational integration of bacterial and viral-responsive immune proteins, Key delivers the BV result in 15 minutes from serum. This test was clinically validated on thousands of patients, is CE-marked and 510(k) pending.
Another pivotal question that the clinician considers during the fever encounter is will this patient deteriorate? Accordingly, to meet the urgent need during the ongoing pandemic of risk stratifying COVID-19 patients, we are developing MeMed COVID-19 Severity. Also run on Key in 15 minutes and the focus of this application, this new tool provides a score predicting the likelihood of a severe outcome and if care escalation should be considered.
MeMed’s headquarters are in Israel, with a subsidiary in the U.S. MeMed’s international team exemplifies bio-convergence, encompassing experts in molecular immunology, bioinformatics, assay development, engineering, and infectious disease. Currently, commercial, sales, and service divisions are being expanded to support launch.
To meet the urgent need of risk stratifying SARS-CoV-2-positive patients, we are developing MeMed COVID-19 Severity, an easily interpretable host-protein signature that includes viral-induced proteins. By encompassing viral pathways, it enables insight into the immune dysregulation associated with COVID-19 disease progression, diverging from the mainstream attention to individual bacterial severity markers. Our technology is an objective, broadly applicable, and accurate tool for deciding which adult COVID-19 patients are likely to deteriorate and need escalation of care.
Beyond its clinical value in improving patient outcomes, hospitals may possibly derive operational and economic benefits from the technology, such as: better resource allocation; cost savings through decreased length of stay of COVID-19 patients; and outpatient service revenues from discharged COVID-19 patients who would otherwise have been admitted.
Importantly, MeMed COVID-19 Severity runs in 15 minutes using serum on MeMed Key, a platform capable of measuring multiple proteins across a wide dynamic range with laboratory precision. Accordingly, our technology is uniquely relevant to COVID-19 disease, providing actionable and prognostic test results during the clinician’s decision-making workflow.
numares.com
AXINON System
numares AG, headquartered in Regensburg, Germany, is an international diagnostics company that develops advanced analytical tests by applying artificial intelligence (AI) to complex metabolomics data for multi-parametric biomarker discovery. The AI-driven discovery process is coupled with Magnetic Group Signaling (MGS), a proprietary technology that standardizes nuclear magnetic resonance spectroscopy (NMR)-derived signals, and the AXINON System, which enables high-throughput and precise NMR signal analysis for identification of metabolite constellations usable for clinical diagnostics. Metabolomics lags genomics and proteomics in precision medicine but our biomarker discovery process and laboratory use technology addresses the unmet needs for metabolic precision medicine in cardiovascular, kidney, liver, and neurological diseases.
We use artificial intelligence (AI) to extract all metabolic information from a single measurement (spectrum) with nuclear magnet resonance (NMR) to diagnose complex medical conditions.
Thus, the AXINON technology is the first and so far only in vitro diagnostic technology which facilitates AI to transfer the research-based NMR spectroscopy into automated, easy-to-use metabolomic multi-marker tests in a standardized high-throughput clinical routine diagnostic setting. This new approach not only yields better diagnostic performance in existing indications, but also opens the door for the diagnosis of diseases with one sample, which required elaborate diagnostic procedures in the past.
As an example, for one application (test) of the technology we developed the AXINON Clearance Check test, which uses the AXINON technology not only to more precisely measure kidney function, but also has the potential to report a signature of the metabolic status of the organ, indicating the source of the kidney dysfunction. This will enable the physician to individually treat each patient – not only based on symptoms but on the metabolic cause. Next to nephrology, tests are currently in development in the fields of hepatology, neurology, transplantation, and oncology.
OncoHost.com
PROphet
OncoHost is a clinical stage precision oncology start-up that combines proteomic analysis with artificial intelligence to predict response to immunotherapy and analyze resistance mechanisms, providing clinicians with potential combination strategies to optimize treatment. OncoHost has developed a first-of-its-kind host response profiling platform, PROphet. The platform analyzes proteomic changes in patient blood samples to detect signs of resistance to cancer therapies in real-time, enabling biomarker-guided treatment planning for physicians, target discovery for drug development and, ultimately, improved outcomes for patients.
The idea behind OncoHost began with a burning question: Why do cancer treatments help some patients but not others? Co-founder and chief scientist, Prof. Yuval Shaked, head of the Integrated Cancer Research Center at the Technion - Israel Institute of Technology, discovered that a patient’s biological response to anti-cancer treatment, known as the “host response,” may actually facilitate and support tumor growth and spread. In what seems like a paradoxical reaction to treatment, our own body may actually help the tumor cells evade the effect of the cancer treatment.
Over 15 years of research, Shaked discovered that host response is a universal phenomenon regardless of the treatment modality (chemotherapy, targeted therapies, immunotherapy, and even radiation and surgery). This encouraged OncoHost to develop a system that can decipher the host response in order to identify which treatments are best suited for individual patients, and which should be avoided. PROphet scans about 1,000 proteins in a patient’s plasma and then uses machine learning tools to identify a “protein signature” that can classify responders and non-responders. In addition, PROphet can identify potential resistance-associated mechanisms and resistance-associated proteins, flagging the therapies most likely to help an individual patient.
www.sightdx.com/us
Sight OLO
Sight Diagnostics is a blood diagnostic company that leverages machine vision and artificial intelligence to transform health systems and patient outcomes through fast, accurate, and convenient blood testing. Sight’s technology, developed with over a decade of research, combines the latest innovations in blood sample preparation, optics, chemistry, biology, physics, and computer science, representing breakthrough innovations in the diagnostic methodology.
Sight’s first product, Parasight, has diagnosed malaria in nearly 1 million tests across 24 countries. Sight OLO, Sight’s latest blood analyzer, digitizes blood with only 2 drops of a finger prick or venous sample and provides accurate, lab-grade complete blood count results in minutes. In the U.S., Sight OLO has Food and Drug Administration 510(k) clearance for use in moderate complexity settings. Outside of the U.S., Sight OLO is CE Marked for use in point-of-care settings.
Sight Diagnostics aims to decentralize diagnostics, and that requires technologies that are accurate, affordable, and scalable. One of the most commonly ordered blood tests that helps providers accurately diagnose patients is a complete blood count (CBC), with four billion tests ordered annually. Doctors rely on CBC as the first line of questioning for patients with fevers, low energy, and routine checkups because it helps narrow down the patient’s potential diagnosis. Existing flow cytometry-based solutions, or “wet”-based methods, require expensive reagents and cleaning fluids and are not designed for near-patient testing.
Recognizing the need to bring rapid, lab-grade CBC testing to near-patient settings, Sight Diagnostics developed Sight OLO, an artificial intelligence (AI)-based blood diagnostics analyzer that offers accurate CBC results from just two drops of blood in minutes.
Sight OLO leverages a patented method of “digitizing” blood samples and is built with high-powered microscopes, computer vision, and AI, allowing it to deliver lab-quality results in a much more compact and efficient format than traditional CBC machines. The analyzer’s computer vision technology produces over 1,000 highly detailed images of blood from each blood sample. It then deploys fully automated AI algorithms to measure, classify, and count the different cells and identify abnormalities. As a result, Sight OLO measures 19 different parameters with 5-part differentials.
Sight OLO can be used with patients aged 3 months and above and in any clinical setting, making the technology accessible on a global scale.
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