The FDA has cleared Memed Diagnostics Ltd.'s blood test for distinguishing between bacterial and viral infections. The diagnostic test has been tipped as an essential step in the fight against antimicrobial resistance. While most infectious disease tests look for the pathogen, Memed BV is an advanced host immune response test that measures the levels of immune system proteins and applies proprietary algorithms to generate an immune signature.
Merck KGaA has signed an agreement with French company Biocorp SA to develop a version of its Mallya smart device for monitoring human growth hormone (HGH) treatment. Mallya is a clip-on device for pen injectors that collects the dose and time of each injection and transfers the information in real time to a companion software using Bluetooth technology. The device is CE marked (Class IIb) and was first launched in France in 2020.
A multicenter study has found that a multiplex diagnostic panel developed by Opgen Inc. can reduce the use of inappropriate antibiotic therapy by 45.1%. Opgen’s Unyvero Hospitalized Pneumonia (HPN) panel uses PCR technology that can detect 21 pathogens and 17 antibiotic resistance markers in less than five hours. During the European Respiratory Society conference, Rockville, Md.-based Opgen presented data showing that combined with antibiotic stewardship, its HPN panel decreased time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods.
Three is the magic number for Finnish companies Abacus Diagnostica Oy, Kaivogen Oy and Labrox Oy as they link up to develop a new diagnostic solution combining antibody and PCR testing on a single device. The three Turku, Finland-based companies said they are joining forces to form a new diagnostics powerhouse, harnessing their own unique expertise. Abacus Diagnostica develops molecular testing and rapid PCR tests while Kaivogen specializes in immunoassays and antibody tests and Labrox on laboratory instruments. All companies have previously collaborated on R&D projects.
Startup company Medial Earlysign Ltd. and Roche Diagnostics International Ltd. are teaming up to bring to market artificial intelligence (AI) solutions for early detection of cancer. Founded in 2013, Tel Aviv-based Medial Earlysign uses machine learning tools to flag patients with a high probability of developing specific illnesses. The partnership with Roche will initially focus on gastric cancer.
Nectero Medical Inc. has secured $19.5 million in a series C financing round, led by Boston Scientific Corp. The company is developing the Endovascular Aortic Stabilization Treatment (EAST) system, a treatment platform that reduces the growth rate of aortic aneurysms. EAST is currently in a multisite phase I safety study for abdominal aortic aneurysm (AAA) patients and the financing will be used to fund further in vivo and clinical development.
The share price of Renovorx Inc. has spiked following FDA clearance for its Renovocath delivery system. Since the company announced the clearance, its stock (NASDAQ:RNXT) has climbed by more than 13%. Last month the company completed an IPO for approximately $16.6 million, issuing shares at $9-$11.
Savicell Diagnostics Ltd. has reported high accuracy results from a study validating its liquid biopsy platform Immunobiopsy. Haifa, Israel-based Savicell said the platform achieved high accuracy identifying lung cancer across stages I to IV. In a cohort of 245 participants, the Immunobiopsy test achieved 97% sensitivity and 97% specificity among patients with lung cancer.
Stryker Corp. has made its second acquisition of the year, picking up Gauss Surgical Inc. – the developer of an artificial intelligence (AI) platform for real-time monitoring of blood loss during surgery. Financial terms of the deal were not disclosed. Kalamazoo, Mich.-based Stryker’s shares (NASDAQ:SYK) were trading 5% higher following the acquisition. Menlo Park, Calif.-based Gauss Surgical’s Triton AI technology aims to fill a void in maternal health by enabling early detection of hemorrhage.