August 24, 2020 | August featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Adaptive Biotechnologies, Strata Oncology, and more.
Bionano Genomics has acquired Lineagen, a Salt Lake City, Utah-based genetic diagnostic company. Bionano’s Saphyr genome imaging platform outperforms other methods for clinical cytogenetic testing, karyotyping, chromosomal microarray (CMA) and fluorescence in-situ hybridization (FISH). Lineagen specializes in pediatric neurodevelopmental disorders, including autism spectrum disorder and developmental delay, and has developed proprietary technology and commercialized multiple LDTs. With the acquisition of Lineagen, Bionano adds CLIA-certified diagnostic testing services along with expertise in commercializing cytogenetic assays, genetic counseling, third party payor contracts and reimbursement. Press release.
FDA has granted HelixBind a Breakthrough Device Designation for RaPID/BSI, the first test on HelixBind’s direct-from-blood platform for the identification and characterization of bloodstream infections. RaPID/BSI identifies the most common bloodstream infections associated with sepsis. HelixBind’s submission to the FDA focused on the features of the RaPID platform that distinguish the test from the current standard of care, and meet the criteria for the breakthrough designation: the fast turnaround time of a few hours, the large panel of twenty-one bacterial and fungal pathogens covered by a single test, and the high sensitivity of the test to identify very small concentrations of pathogens contained within a blood specimen. Press release.
Renalytix AI has announced a collaboration with AstraZeneca to develop and launch precision medicine strategies for cardiovascular, renal and metabolic diseases. The first stage in the collaboration will use KidneyIntelX, an artificial intelligence-enabled in vitro diagnostic platform, to examine further improving outcomes for patients with chronic kidney disease (CKD) and its complications, in coordination with the Mount Sinai Health System.The first stage will assess the impact of AI-enabled in vitro diagnostic solutions to optimize utilization of therapeutics in CKD under current standard of care protocols. Based on study outcomes, a multi-center, randomized controlled trial will be initiated to evaluate uptake and adherence to new potassium-binding agents in patients with CKD and hyperkalemia. The studies will be conducted in coordination with the Mount Sinai Health System, where KidneyIntelX testing and care management software are currently being deployed for commercial clinical use. Press release
Adaptive Biotechnologies received clearance from the U.S. Food and Drug Administration (FDA) for its clonoSEQ Assay to detect and monitor minimal residual disease (MRD) in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is the first and only FDA-cleared in vitro diagnostic for MRD monitoring in CLL. This clearance expands the existing FDA-cleared uses of clonoSEQ, as the FDA previously granted the assay De Novo designation for the detection and monitoring of MRD in bone marrow from multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) patients. Access to clonoSEQ for CLL patients nationwide is supported by the already-established Medicare coverage of clonoSEQ in CLL, as well as by the FDA’s clearance of clonoSEQ testing for CLL patients in blood and marrow. Medicare coverage is critically important in CLL, as nearly 80 percent of patients living with CLL in the U.S. are of Medicare age. clonoSEQ’s ability to detect MRD in blood provides CLL patients and health care providers with a more convenient and less intrusive option to monitor disease burden. Press release
Israeli startup PulseNmore today announced the launch of its flagship handheld tele-ultrasound device that enables pregnant women to perform at-home ultrasound scans, and receive feedback from a physician or sonographer. Clalit Health Services, Israel’s largest HMO and the one of the largest public HMOs in the world with 4.6 million insured members, is the first healthcare provider to purchase the device, signing a multi-year agreement to provide tens of thousands of its pregnant members with PulseNmore’s product. The PulseNmore device docks with a smartphone and uses advanced navigation and AI tools as well as an app to guide users through the scanning process, displaying and sharing high quality images with their healthcare professional. Physicians or sonographers review the scans remotely off-line or in real-time using telemedicine platforms and can reassure parents that all is well, or instruct them on appropriate next steps, if necessary. Press release.
Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Hengrui Therapeutics (HTI) to develop a CDx that will leverage the Oncomine Precision Assay, which runs on the new Ion Torrent Genexus System. Once commercialized, the CDx will be used to identify non-small cell lung cancer (NSCLC) patients who may be eligible for pyrotinib, JHM's novel, irreversible pan-HER2 tyrosine kinase inhibitor. HER2 mutations are present in about 4% of patients with NSCLC, yet there is currently no targeted therapy approved by the U.S. Food & Drug Administration (FDA) for patients with HER2-mutated NSCLC. HTI recently released results from a phase 2 clinical trial demonstrating that pyrotinib showed promising antitumor activity in patients with HER2-mutant advanced NSCLC who were previously treated with chemotherapy. The drug received conditional approval in China for the treatment of HER2-positive, advanced or metastatic breast cancer in chemotherapy-treated patients in 2018 based on positive phase 2 clinical trial results and full approval in 2020 based on two successful phase 3 studies. HTI's global clinical trial program for pyrotinib is currently in phase 3 clinical trials, with studies underway in China, Europe and the United States. "An approved targeted therapy for patients with HER2-mutated non-small cell lung cancer could save thousands of lives," said Dr. Lianshan Zhang, R&D president of JHM, in a press release. "We are excited to partner with Thermo Fisher on a companion diagnostic that will make it easier for clinicians to identify patients who may benefit from pyrotinib, helping us broaden participation in clinical trials and make precision medicine available for more patients." Under the terms of the agreement, Thermo Fisher will retain rights to commercialize the test globally and will seek approval from regulatory agencies. The company has previously announced a CDx agreement that also leverages the Oncomine Precision Assay for the Genexus System. Press release
Strata Oncology announced it has signed an agreement with BioMed Valley Discoveries to accelerate patient identification and enrollment for BioMed Valley's Phase 2 study of BVD-523 (ulixertinib) for patients with advanced malignancies harboring MEK or atypical BRAF alterations (non-BRAF V600E mutations). Ulixertinib is a first-in-class potent and selective small molecule inhibitor of ERK1/2. BioMed Valley reported positive preliminary Phase I data for ulixertinib in patients harboring MAPK alterations, including atypical BRAF alterations. Under the terms of the agreement and through the Strata Trial, Strata Oncology will identify patients with advanced solid tumors that harbor mutations in the MAPK signaling pathway and meet other eligibility criteria, for consideration of enrollment into BioMed Valley's Phase 2 study. The Strata Trial, an ongoing observational study providing tumor molecular profiling for patients with advanced cancer paired with a portfolio of biomarker-guided clinical trials, is available across a network of 25+ select health systems nationwide. Through the Strata Trial, patients with advanced cancer are profiled using StrataNGS, a comprehensive molecular profiling test optimized for performance on tissue samples as small as 0.5mm2 surface area. Press release
Random Walk Imaging AB (RWI) announced the launch of its first commercial software product for clinical researchers and radiologists. The dVIEWR Powered by MICE Toolkit is the result of a collaboration with NONPI Medical AB, with whom RWI has entered into an exclusive license and development agreement to market dVIEWR worldwide. dVIEWR provides novel parameter maps that offer actionable information on tissue microstructure at an unprecedented level of detail and precision. By powering the software through MICE Toolkit, the ‘drag and drop’ interface allows clinical researchers without extensive programming experience to run custom image analysis workflows, quickly and easily. Similarly, the interface also benefits more experienced users to customize their own workflow designs, inputs and outputs. “The value that this level of detail and precision in diffusion MRI offers has most recently been shown in a multiple sclerosis study published in Brain Communications. In the study, the unique parameters acquired using RWI’s advanced protocols could be correlated to clinical scores, which had not been seen with conventional methods such as diffusion tensor imaging,” said Peter Hoffmann-Fischer of Random Walk Imaging, in a press release. “With dVIEWR, we have now made it even easier for researchers to incorporate these workflows and obtain novel contrasts for further analysis or formal presentation.” Press release
FUJIFILM Medical Systems U.S.A. announced that effective October 1, 2020, it will add In Vitro Diagnostics (IVD) to its portfolio of healthcare solutions with the integration of FUJIFILM Wako Diagnostics U.S.A. Corporation, a provider of IVD and life science products. The integration will enhance FUJIFILM Medical Systems U.S.A. Inc.’s portfolio of diagnostic solutions for its healthcare customers through the addition of IVD clinical lab reagents and biomarkers. “With an established portfolio of diagnostic imaging solutions to enable treatment planning, diagnosis and healthcare IT, we look forward to expanding our solutions to include IVD,” said Jun Higuchi, president and chief executive officer, FUJIFILM Medical Systems U.S.A., Inc., in a press release. “The addition of IVD to our diagnostic portfolio will enable us to provide clinicians with tools to assess risks of disease development through our biomarkers and our existing diagnostic imaging solutions.” FUJIFILM Wako Diagnostics has an established portfolio of biomarkers to assess the risk for the development of hepatocellular carcinoma (HCC) in patients with chronic liver disease. Its IVD portfolio of solutions also includes IVD reagents and systems focused on areas including disorders of lipid metabolism, lupus, rheumatoid arthritis, coronary heart disease, and diabetes. The new IVD group will be led by Hidetoshi (Henry) Izawa, vice president of modality solutions and clinical affairs, FUJIFILM Medical Systems U.S.A., Inc. As part of his current role, Mr. Izawa oversees digital radiography, computed radiography and women’s health groups. Previously, he was responsible for radiology, IVD and endoscopy for FUJIFILM France, and was the Head of Modality for Europe. Press release