NEW YORK – Siemens Healthineers and Braunschweig Municipal Hospital in Germany said this week that they inked a 10-year €80 million contract to establish a diagnostics and analysis center at the hospital. Under the terms of the deal, Siemens will be the general contractor and supplier of all medical technology for a highly automated interdisciplinary center, and it will bring on partner companies to provide technical equipment for specialty lab areas. The lab will include about 300 laboratory devices including Siemens' Atellica Solution and Atellica CI Analyzer instruments. It is expected to begin providing patient care in mid-2025 with a menu of more than 1,000 test methods and analysis options.
Bio-Techne announced this week that its Wallingford, Connecticut-based facility, which manufactures the firm’s Simple Plex immunoassays for its Ella system, has received ISO 13485 certification for its quality management system. The standard creates a quality system framework for the design, development, and manufacturing of medical devices to ensure their safety and effectiveness. To receive certification, companies must show that critical components are designed and manufactured to meet customer and regulatory requirements, Bio-Techne said in a statement.
BGI Genomics said this week that an IVD test kit factory in Addis Ababa, Ethiopia, that is operated by its subsidiary, BGI Health Ethiopia, is preparing to manufacture test kits for seven diseases with high prevalence in Ethiopia and Africa at a new location. The original factory has obtained ISO 13485 certification and is awaiting a good manufacturing practices inspection for the new location. According to BGI Genomics, it produced RT-PCR and rapid antigen test kits during the COVID-19 pandemic. It has also received certification from the Ethiopian Food and Drug Authority for hepatitis C virus, pregnancy urine, syphilis, and typhoid rapid diagnostic tests. --
Burning Rock Biotech said this week that its OverC multi-cancer detection blood test has been granted breakthrough device designation by the China National Medical Products Administration. The test is intended for early detection of multiple cancer types in adults of either sex, aged 50-75 years old, who are at average risk for cancer. The assay demonstrated 69 percent sensitivity and 99 percent specificity in the company's case-control study, THUNDER, with up to 92 percent accuracy in predicting tumor tissue of origin.
University of Pennsylvania spinout FloBio said this week that the US Food and Drug Administration has granted breakthrough device designation for its rapid point-of-care test for determination of patient clotting status. The Philadelphia-based company's automated hemodynamic assay provides information on a patient's blood clotting status, including anticoagulation from taking a direct oral anticoagulant (DOAC). The firm said it is developing a platform to help guide treatment and cost-effective management of blood clotting abnormalities and serious bleeding.
Oxford BioDynamics said this week that it and UK health insurer Bupa have entered a strategic agreement that gives Bupa patients access to Oxford's EpiSwitch CiRT (checkpoint inhibitor response test). Developed using the company's proprietary 3D genomic biomarker platform, the assay is intended to predict individuals' responses to this class of immunotherapy drugs, aiding oncologists in selecting appropriate treatment. Under the new agreement, the CiRT test will be available to doctors considering treating Bupa customers with an immune checkpoint inhibitor, where decisions need to be made in the face of potential serious illness and lack of response to treatment.
Gradientech announced this week that it has signed an exclusive distribution agreement with Iberlab, a supplier of diagnostic systems and consumables for clinical labs, for the commercialization of the QuickMIC molecular diagnostic system in Portugal. Gradientech has previously signed agreements for the commercialization of QuickMIC in Austria, Central Eastern Europe, Sweden, Denmark, Norway, Iceland, and the Baltics.
Seren and SerenOx Africa said last week that they opened a hematology clinic and laboratory in Tanzania to offer low-cost diagnostic testing to sub-Saharan Africa. The organizations said underdiagnosed diseases in the region, including sickle cell disease, can be cured or controlled with affordable therapies when patients have access to diagnostic testing. UK-based Seren is a University of Oxford spinout that applies technologies developed at the university to delivering rapid diagnosis of inherited blood disorders, infectious diseases, and early-stage cancers. Seren, Oxford, and the UK National Institute for Health and Care Research support SerenOx Africa, a Tanzania-based organization dedicated to advancing diagnostics in Africa through access to molecular testing.
Life sciences firm Fapon and telehealth provider Halodoc said last week that they will form a joint venture that will combine Fapon's in vitro diagnostics technologies with Halodoc's sales channels and local services in Indonesia. Under the agreement, Fapon will provide raw materials, reagent solutions, and open-instrument platforms for use in product research and development, and Halodoc will leverage existing connections through sales channels, academia, and industry to hasten market expansion and business growth.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.