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Diagnostics News from Oxford Nanopore, Vizgen, BGI Genomics, More

April 27, 2023 | Oxford Nanopore enters the diagnostics market with bioMérieux collaboration, BGI Genomics agrees to tech transfer in southern Africa, and more. Plus new products from Vizgen, Agilent, Capitainer, and Metabolon.

Myriad Genetics and Intermountain Precision Genomics, a service of Intermountain Health, are now certified to offer solid tumor testing to patients in all 50 U.S. states after receiving the New York State Clinical Laboratory Permit. This achievement follows a recent site inspection as part of the New York State Department of Health Clinical Laboratory Evaluation Program. Myriad’s Precise Tumor test, also offered by Intermountain Precision Genomics as TheraMap: Solid Tumor, analyzes a patient’s tumor DNA to discover what changes, or gene mutations, are causing the cancer. Specialists apply the results to recommend a targeted treatment plan for the patient’s unique tumor profile. Press release.

Oxford Nanopore Technologies and bioMérieux SA have teamed up to improve health outcomes globally by exploring selected opportunities to bring nanopore sequencing to the infectious disease diagnostics market. The companies are jointly exploring selected opportunities to advance patient care by providing access to nanopore-based clinical research and in vitro diagnostic (IVD) solutions. Initial areas of collaboration will include a test for determining antibiotic resistance of tuberculosis; an assay to identify pathogens in normally sterile clinical samples; and validating Oxford Nanopore’s sequencing platform with BIOMÉRIEUX EPISEQ CS application for rapid infection outbreak monitoring in patient-care settings. Press release.

Vizgen has launched the MERSCOPE PanCancer Pathways Panel. The PanCancer Pathways Panel features a list of genes targeting canonical signaling pathways of cancer and is constructed using recognized oncology databases including OncoKB, MutSig, the Cancer Genome Atlas, and Hallmarks of Cancer to ensure inclusion of critical cancer genes. The Panel provides a key tool for researchers to study tumor behavior at cellular and subcellular levels across multiple different types of cancers. The PanCancer Pathways Panel features characterization of major oncology signaling pathways including RAS/RTK, PI3K, NOTCH, MYC, Cell Cycle, HIPPO; inclusion of cell type markers to identify healthy and disease states; and compatibility across multiple cancer types. Press release.

Medical technology company Capitainer has launched a fully automated sample handler that enables large-scale screening and diagnostics using the company’s self-sampling products. This technology effectively cuts down on the number of manual steps and reduces the time that laboratory staff spends preparing Capitainer samples for analysis. The new, fully automated sample handler PA496 (Pre-analytical Automation 4 x 96 for Capitainer) is able to handle large volumes of sampling cards, processing up to 400 samples at a time. The sample handler transfers the dried blood samples from Capitainer cards to designated wells in 96-well plates. The ID number of each sample is scanned, and the dried blood samples are photographed to ensure the highest standards in terms of sample quality and traceability. The PA496 has been developed in partnership with Intema and is produced exclusively for Capitainer. Press release.

Agilent Technologies has launched the Agilent SureSelect Cancer CGP Assay designed for somatic variant profiling for a broad range of solid tumor types. The pan-cancer assay design is based on an NGS panel comprising 679 genes globally curated from leading cancer databases and in partnership with key clinical cancer researchers. The assay workflow is efficient, automatable, and flexible, making tumor molecular profiling more accessible to the broad clinical research community. The biomarkers include key classes of somatic variants (SNVs, CNVs, indels, translocations, de novo gene fusions), along with the immuno-oncology biomarkers TMB (tumor mutational burden), and MSI (microsatellite instability) to aid clinical and translational researchers in investigating potential cancer therapeutics. Based on Agilent’s industry-leading library prep and target enrichment chemistry, this high-performance assay provides up-to-date, globally curated biomarker content for comprehensive molecular profiling of solid tumors, supports as low as 10 ng of input, and incorporates walkaway automation to improve lab efficiency and productivity. The workflow incorporates flexible data analysis options, including Alissa Interpret for tertiary analysis and reporting, customer bioinformatics pipelines, and third-party software. Press release.

Metabolon has launched its Bile Acids and Short Chain Fatty Acids Targeted Panels that measure microbially-derived metabolites of biological significance to identify biomarkers for the prediction and early detection of disease areas, including oncology, neurology, liver, diabetes, and gastrointestinal, and gut health. Together, this new suite of panels targets dozens of microbially-derived metabolites across multiple pathways, including bile acid metabolism, sulfur metabolism, nitrogen metabolism, and vitamin B metabolism to advance pre-clinical and clinical research efforts. Metabolon’s Short Chain Fatty Acids Targeted Panel measures nine metabolites and can be used to track biomarkers and enhance biological understanding across preclinical and clinical research. Metabolon’s Bile Acids Targeted Panel measures 21 metabolites and has been designed specifically to advance pre-clinical research identifying bile-acid related biomarkers in digestive, metabolic, and neurological health. Press release.

Akili Labs and BGI Genomics agreed upon a technology transfer agreement to provide the Southern region of Africa with clinical-grade sequencing solutions. Improving genetic sequencing services' cost and turnaround time will play a major role in expanding precision medicine-driven healthcare in Africa. The partnership will supply the first truly Africa-based service to meet client needs and process samples locally in full compliance with regional data protection laws. With the continent home to the world's most diverse genomics data, local talent must have the tools and resources to develop localized genomics sequencing capabilities focusing on improving health outcomes. Press release.

BGI Genomics launched COLOTECTTM 1.0 in Slovakia, collaborating with its local partner, Zentya. COLOTECTTM 1.0 is one of the first-ever fecal DNA tests for colorectal cancer that is available in the country. It is a non-invasive fecal DNA test developed by BGI Genomics for detecting colorectal cancer and precancerous lesions. It uses multiplex methylation-specific PCR (MSP) technology to trace abnormal colorectal cancer DNA-methylation biomarkers from fecal samples. Fecal samples of COLOTECTTM 1.0 can be self-collected in the privacy of your own home at any time. In addition, the ease of use and non-invasive nature of the test is expected to help overcome many of the obstacles to colorectal cancer screening faced by patients. Press release.

The University of Tartu, Estonia, was selected by the European Medicines Agency as one of the data partners of the DARWIN EU network. This is a first step towards the common use of health data in Europe to support public health, medicines regulation, and safety based on evidence from data collected in the routine provision of healthcare. Joining the DARWIN EU data network is a great recognition of the work that has been done and a good opportunity for Estonia to cooperate internationally in the health field. As a result of the accession, Estonia's health data will be integrated into a wider network of real-world data and evidence-based conclusions on the use, safety, and efficacy of medicines will influence patient care across Europe. The inclusion in the DARWIN EU network has also been facilitated by the Estonian Biobank's unique database, which brings together genetic and health data from over 200 000 Estonians. Press release.