September 29, 2022 | An RNA-based diagnostic workflow for detecting mRNA expression of standard breast cancer biomarkers; an automated TB test for immunocompromised patients; a companion diagnostic for detecting genomic alterations; and more.
Apis Assay Technologies launched a new advanced subtyping kit for breast cancer. This new innovative assay addresses several unmet needs in current practice, including providing highly reproducible results, particularly for low HER2 expression. The new Breast Cancer Subtyping Kit is an RNA-based diagnostic workflow for detecting mRNA expression of standard biomarkers (ER, PR, HER2, Ki67) and novel proliferative biomarkers from pre-operative core-needle biopsy or resected formalin-fixed paraffin-embedded breast tumor tissue. Press release.
Enzo Biochem announced the launch of the AMPIVIEW line, an RNA gene expression platform powered by Enzo’s LoopRNA in situ hybridization technology. The AMPIVIEW platform, with its first products for HPV detection and analysis, combines the precision of targeted, sequence-specific probes with the superior sensitivity of its novel LoopRNA ISH technology. This innovative design enables sensitive and specific detection of target genes in tissue or cell samples while preserving the morphology. Press release.
Henry Ford Health and GRAIL announced Henry Ford Health as the first healthcare provider in Michigan to offer Galleri, GRAIL’s multi-cancer early detection blood test. The Galleri test is intended for individuals ages 50 or older. Still, Henry Ford is making it available to patients 22 years or older with no history of cancer, who have been cancer-free for at least three years, and who are not currently pregnant. The Galleri test looks at the DNA in a patient’s blood to determine if any of it may have come from cancer cells and can detect up to 50 types of cancer. Galleri is available by physician order only. Press release.
PerkinElmer’s Oxford Immunotec announced that the U.S. Food and Drug Administration had approved the T-Cell Select reagent kit to automate its T-SPOT.TB test workflow for in vitro diagnostic use by certified laboratories. The T-Cell Select reagent kit allows for a more automated workflow, designed to reduce the hands-on time for lab personnel and lower overall costs. The increased use of automation allows for a standard blood collection tube to be stored at room temperature for up to 54 hours with no complex phlebotomy practices. The T-SPOT.TB test with the T-Cell Select reagent kit is the only automated Interferon-Gamma Release Assays TB test without regulatory (label) warnings for immunocompromised patients, who often have lower levels of T cells available to evaluate. Press release.
Innovative Health Diagnostics (IHD) announced the launch of its diagnostics as a service platform, giving brands the ability to provide their patients with access to at-home healthcare at any time and anywhere. Digital health and healthcare direct-to-consumer entities can utilize IHD’s partner platform to offer consumers over 70 different at-home tests, from infectious disease and wellness to women’s and men’s health. The platform bridges the gap between digital health services and diagnostics, creating a complete customer experience with an emphasis on fast turnaround times, actionable results, and superior customer service provided by IHD. Press release.
Quantics Biostatistics launched the latest version of its bioassay software, QuBAS 3.0, to provide greater flexibility and a new user interface, resulting in significant time savings for early-stage assay development while retaining the unique continuous real-time validation system that has made QuBAS so successful. QuBAS 3.0 allows researchers to build their analysis without workflow controls and offers an ideal system for routine analysis with 21 CFR part 11 and good manufacturing practice compliance. In addition, each analysis report is created with a full audit trail and real-time validation record, meaning minimal user report quality control is required. Press release.
Foundation Medicine announced a collaboration to develop FoundationOneCDx as a companion diagnostic for Day One’s lead investigational therapy, tovorafenib (DAY101). Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If tovorafenib, and this companion diagnostic indication are approved, this would be the first companion diagnostic indication for FoundationOne CDx in pediatric oncology. Press release.
Propath UK and Nucleai announced their collaboration to develop and validate a 30-plex immunofluorescence panel focused on protein targets relevant to immuno-oncology. Nucleai’s proprietary AI-powered, pathology-based biomarker discovery platform combined with Propath’s multi-omic spatial biology and high-plex immunofluorescence will accelerate the pharmaceutical industry’s drug development and research programs. In addition, the combined expertise will allow computational analysis of the tumor microenvironment, feature selections to predict disease prognosis and drug response, and support early detection and prognosis. Press release.
OpGen announced the signing of an R&D collaboration agreement with FIND for the Unyvero A30 RQ platform for use in rapid pathogen infectious disease and antimicrobial resistance (AMR) testing from blood culture samples in low and middle-income countries (LMICs). The Unyvero A30 RQ platform is a sample-to-answer instrument running a disposable one-time-use cartridge that can test for up to 33 diagnostic targets from a single specimen. If successful, a future collaboration agreement would aim to make the Unyvero A30 RQ platform and initial application products commercially available at an attractive cost profile, which can address the unmet medical need for rapid AMR detection in LMICs. Press release.
Rheonix announced that the United States Food and Drug Administration issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19 MDx Assay to include home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit. Rheonix’s fully automated sample-to-answer COVID-19 assay received its initial EUA for use on a range of respiratory specimens on April 29, 2020. The EUA has subsequently been expanded to include saliva as a sample type and used by both moderate and high complexity laboratories. Press release.
The Azerbaijan Thalassemia Center and BGI held a virtual signing ceremony to seal a collaboration agreement to improve thalassemia screening in Azerbaijan through genetic technology. The Azerbaijan Thalassemia Center is the region's leading public medical institution fighting thalassemia. This center provides services for patients suffering from this disease and people with other genetic conditions while offering a foundation providing medical services to foreign citizens. Press release.
NIMA Partners announced that they have entered an exclusive partnership with Clinical Enterprise to cross-promote a new, revolutionary, at-home Celiac Risk Gene Test. Celiac disease is an autoimmune, genetic condition where the body's immune system attacks the small intestine when gluten is consumed. The human leukocyte antigen marker results are provided to individuals through a secure online portal ten business days after sample receipt at the company's Clinical Laboratory Improvement Amendments-certified lab. Press release.
PathogenDx launched a new patented virus detection technology, Phytox, to help curb the spread of new and existing plant-borne pathogens, which are currently on the rise. The new Asymmetric RT-PCR microarray technology for the cannabis, food, and agriculture sectors can detect nine viruses or more in a single test, providing simultaneous and accurate viral detection in approximately three hours. In addition, Phytox saves testing labs 70% in costs and delivers up to 100% times greater sensitivity when detecting specific viruses while amplifying viral target DNA to its endpoint, identifying viruses without cross-reactivity, and preventing misdiagnosis. Press release.
DiaSorin announced that it received 510(k) clearance from the U.S. Food and Drug Administration for its Simplexa COVID-19 Direct kit. The kit provides a sample-to-answer test for detecting SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens. This COVID-19 molecular assay can be used by hospital or commercial laboratories allowing for timely testing and highly accurate results. The Simplexa COVID-19 Direct test differs from other automated PCR assays with extraction as it does not require sample pre-treatment, enabling a fast time-to-result, allowing prompt decision-making regarding isolation and treatment of infected patients. Press release.
Unilabs and Proscia announced that Proscia's DermAI would advance their aspiration of becoming the most digitally-driven diagnostic group, enabling better decisions for a healthier tomorrow. The artificial intelligence (AI)-enabled technology will first be deployed in Sweden and then rolled out across other countries where Unilabs serves patients. Proscia's DermAI is designed to classify H&E stained dermatopathology slides automatically and highlights the promise of computational pathology in driving critical productivity gains. Press release.
Eligo Bioscience and Kantonsspital St. Gallen announced their strategic alliance to develop a gene editing therapy for inflammatory cardiac diseases induced by bacterial mimicry. The collaboration builds on the foundational research published in Science (DOI: 10.1126/science.aav3487), and leverages Eligo’s proprietary technology for in vivo gene editing of the microbiome. The alliance between Eligo Bioscience and Kantonsspital St. Gallen will accelerate the development of novel therapies for inflammatory cardiac diseases by combining Kantonsspital St. Gallen’s disease and patient insights and access to key patient samples, data, and animal models, with Eligo’s unique gene-editing platform. Press release.
Strata Oncology announced the expansion of its clinical collaboration with Pfizer in the Strata Precision Indications for Approved THerapies (Strata PATH) trial. Strata PATH is a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Pfizer will provide Braftovi (encorafenib), Mektovi (binimetinib), and Lorbrena (lorlatinib) for up to six new cohorts of patients with early-stage lung, melanoma, colorectal, and other cancers. An advanced molecular therapy selection profile enables rapid identification of clinical trial opportunities, including Strata PATH, for patients who are positive for ctDNA. Press release.
Deciphex announced the launch of its Diagnexia service in the United States. This virtual pathology service provides on-demand access to remote subspecialty experts for pathology consult services on an advanced collaborative platform. The platform connects laboratories to an international network of subspecialty pathologists who offer their expertise on clinical cases while vastly reducing turnaround times and ensuring the highest quality of patient care. In addition, eligible retiring pathologists may join the Diagnexia network and work remotely part-time. Diagnexia delivers a global network of subspecialty pathology experts to ease pathology bottlenecks, accelerate diagnoses, and enhance patient outcomes. Press release.
Researchers from the Department of Dermatology at the Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, developed a novel imaging technique that significantly improves the accuracy of the diagnosis of basal cell carcinoma (BCC)—the most frequent skin cancer. Their study found that a new, non-invasive skin imaging technology called line-field confocal optical coherence tomography, which gives detailed 3D images at the cellular level, significantly increased diagnostic accuracy. The study also produced a helpful diagnostic algorithm to guide the clinician’s diagnosis of different BCC and BCC-imitator subtypes. Press release.
BGI's Thalassemia Gene Detection Kit has recently obtained CE-IVDD approval. The kit is developed based on the combinatorial probe-anchor synthesis sequencing method, a next-generation sequencing technology, to detect α-thalassemia and β-thalassemia mutations qualitatively. Peripheral blood samples will be used for genetic screening of the general population and diagnosis of abnormal hemoglobinopathy. It was estimated that 5-7% of the world's population carries a mutated gene affecting the production or function of the hemoglobin molecule. Over 330,000 affected infants are born annually (83% sickle cell disorders, 17% thalassaemias). Press release.
The National Institutes of Health launched a $3 million Connecting the Community for Maternal Health Challenge competition to encourage US community-based and advocacy organizations to conduct maternal health research. The challenge is part of the White House Blueprint for Addressing the Maternal Health Crisis. The three-phase challenge is open to non-academic, 501(c)(3) organizations based in the United States, including advocacy, community, and faith-based organizations. Research ideas must align with the goals of the IMPROVE initiative, which aims to reduce preventable causes of maternal death and improve maternal health before, during, and after delivery. Press release.