May 26, 2022 | An AI-based diagnostic histoculture platform preserves human tumor microenvironment; FUJIFILM partners with over 150 imaging centers across the United States; two multiplex respiratory virus tests enable rapid differentiation and detection; and more.
StageZero Life Sciences, a healthcare company devoted to improving the early detection and management of cancer and other chronic diseases through molecular diagnostics and clinical interventions, announced that it has partnered with DiagnoseAtHome to make the company's multi-cancer blood test, Aristotle, available to patients in Canada and the USA. Built on StageZero's proprietary mRNA gene expression technology platform, Aristotle is a next-generation test that simultaneously screens for multiple cancers from a single blood sample with high sensitivity and specificity for each cancer. DiagnoseAtHome offers accessible at-home health and lab testing solutions for safe, accurate, and discreet lab testing as an alternative to in-person laboratory visits. The Aristotle test interrogates mRNA from a whole blood sample and detects gene expression profiles indicative of specific cancers. Press release.
Crosscope, a Silicon Valley-based provider of Vendor Agnostic AI-enabled Digital Pathology Platform, joined forces with Farcast Bioscience. This Florida-based company developed a unique and differentiated human tumor histoculture platform to preserve the entire architecture of the human tumor microenvironment. The two companies will work together for the Prospective Evaluation of OrionA–an AI-based Diagnostic Assistant for Histological Examination of various solid tumors beginning with head and neck squamous cell carcinoma cancer. Crosscope and Farcast aim to accelerate the speed of diagnosis by significantly reducing turnaround times and bringing down the rate of misdiagnosis by leveraging the digitization of pathology. Press release.
MIP Diagnostics, a UK nanotechnology firm, rebranded to MIP Discovery as the business continues its expansion within the healthcare sector. Bedfordshire-based MIP Diagnostics has commercialized Molecularly Imprinted Polymers (MIPs) since its inception in 2015. MIPs are novel nanoparticles designed to mimic antibodies for use in diagnostic tests and other applications. Their unique characteristics have fueled success in the in vitro diagnostics fields. The business is now taking the technology to the broader healthcare market, including drug abuse testing, food safety testing, and cell and gene therapy manufacturing. Press release.
The U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation launched the LymeX Diagnostics Prize exit disclaimer icon, a $10 million competition to accelerate the development of Lyme disease diagnostics. The goal of the competition is to advance the development of these diagnostics for the Food and Drug Administration review. The first phase calls on scientific, technical, and clinical experts to submit innovative methods to detect active Lyme disease infections. Entrants should submit detailed concepts and plans exit disclaimer icons to develop innovative detection methods by August 8, 2022. Press release.
Diagnostics for the Real World, innovator of the SAMBA platform for rapid point-of-care detection of infectious diseases, announced that it had achieved UK technical validation for two multiplex respiratory virus tests (SARS-CoV-2/FluA/FluB and SARS-CoV-2/RSV) that deliver a vital tool for National Health Service care teams. The new combined tests enable clinicians to rapidly detect and differentiate between coronavirus SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus, boosting hospital infection control, optimizing patient management, and speeding access to urgent care services, including emergency surgery. Press release.
FUJIFILM Healthcare Americas Corporation, a provider of enterprise imaging and informatics solutions, announced that RAYUS Radiology, one of the nation’s providers of advanced diagnostic and interventional radiology, has selected Fujifilm’s Synapse Enterprise Information System (EIS) as the workflow management solution for its comprehensive network of over 150 imaging centers across the United States. Synapse EIS is a complete workflow management solution designed with Fujifilm’s Synapse Radiology Information System (RIS) as the foundation. The robust solution delivers enhanced workflow efficiencies, real-time administrative dashboards, and patient and provider engagement interaction tools to support RAYUS’s national network. Press release.
PerkinElmer announced the availability of ultrarapid whole genome sequencing (urWGS) through PerkinElmer Genomics. This addition to the Company’s portfolio of whole-genome sequencing provides physicians with comprehensive, meaningful results within five days to help inform clinical management, reach an accurate diagnosis, and improve outcomes for critically ill neonatal and pediatric patients. The PerkinElmer Genomics urWGS offering uses a dried blood spot sample to provide phenotype-driven analysis with a mean coverage of 40x of a patient’s genome. Press release.
The U.S. National Institutes of Health licensed 11 COVID-19 research tools and early-stage vaccine and diagnostic candidates to the Medicines Patent Pool (MPP) through the World Health Organization’s COVID-19 Technology Access Pool (C-TAP). The licenses will allow manufacturers worldwide to work with MPP and C-TAP to use these technologies for the potential development of COVID-19 vaccines, treatments, and diagnostics to benefit people living in low- and middle-income countries. Included in the technologies licensed is the SARS-CoV-2 stabilized spike protein—a patented invention included in multiple COVID-19 vaccines. Press release.
Applied Biosystems announced a 384-well option for the QuantStudio 7 Pro Dx Real-Time PCR System, providing sophisticated assay design and molecular diagnostic testing flexibility. Thermo Fisher Scientific first introduced the new in vitro system in the U.S. in November of 2021 to enable an easy transition from assay development to routine molecular diagnostic testing on a single system. Users can easily interchange between 96-well and 384-well blocks with the additional format option. This flexibility enables users to expand their assay menus and increase throughput. Press release.
Mauna Kea Technologies announced a new U.S. Food and Drug Administration 510(k) clearance (K220477) for the Cellvizio 100 Series platform with a molecular imaging agent, the first of its kind, for real-time in vivo visualization during endoscopic, laparoscopic, and needle-based procedures. The pioneering category of medical procedures expanded through this new clearance—Molecular Image-guided Procedures (MIP)—is designed to provide Cellvizio the unique clinical ability to visualize tissues to which the molecular agents bind, allowing the potential for real-time visualization of cancer at the cellular level during minimally invasive interventions. For example, MIP use during bronchoscopic lung biopsy may improve the diagnostic accuracy of biopsies while reducing the number of procedures, time, and complications associated with obtaining a diagnosis. Press release.
Alamar Biosciences, a platform company focused on the field of proteomics to enable the early detection of cancer and other diseases, and Mologic, a developer of lateral flow and rapid diagnostic tests (RDTs), announced a collaboration to utilize Alamar’s novel antibodies against SARS-CoV-2 Nucleocapsid protein for Mologic’s future COVID-19 RDTs. Alamar’s proprietary Attobody platform produces a highly diverse pool of antibodies with single-digit picomolar affinity and exquisite specificity. In addition, the Attobody platform deploys an accelerated antibody design and engineering process to generate novel antibodies without affinity maturation compared to traditional antibody engineering. Press release.
NetScientific, the international life sciences, sustainability technology investment, and commercialization group, announces that its wholly-owned subsidiary ProAxsis has completed the development and validation of the AstraZeneca COVID-19 antibody test. The independent performance evaluation study by Prof. Tara Moore of Ulster University analyzed over 1,100 clinical serology samples. The assay detected IgG antibodies in blood samples from previously infected and vaccinated individuals and detected IgG from those infected by the different SARS-CoV-2 variants—Alpha, Delta, and Omicron. This test’s accuracy and ability to detect multiple assay variants make it a valuable tool for vital research, supporting ongoing and future pandemic response strategies and the individual. Press release.