Carbonic anhydrase IX (CAIX) is a transmembrane protein involved in cell proliferation and transformation that is expressed in clear-cell renal cell carcinoma (ccRCC), colorectal cancer (CRC), and other hypoxic tumor types, but has low expression in healthy tissues.
Arizona State University (ASU) reported the receipt of a patent for a device with colorimetric sensors for measuring excreted ketones in a body fluid. Additional sensors may be incorporated to measure flow rate of the body fluid, barometric pressure, humidity, and chemicals such as oxygen and carbon dioxide present in the fluid, and a system to measure metabolic rate and respiratory quotient via oxygen consumption rate and carbon dioxide production rate.
University of California researchers saw publication of their patent application for a multimodal cryptographic bio-human machine interface (CB-HMI), which seamlessly translates the user's touch-based entries into encrypted biochemical, biophysica, and biometric indices.
Springboarding off the success of its AI-based imaging software for cancer detection, the deep learning-based artificial intelligence (AI) company Lunit Inc. has another AI software, called the Lunit Scope, up its sleeve for which it hopes to gain U.S. FDA approval by 2025.
The U.S. FDA is keen on developing policies to guide testing regimes for future pandemics based on the experience with COVID-19, and the FDA’s Tim Stenzel said on a Sept. 8 advisory hearing that automated reporting of at-home tests would clarify questions such as the spread of the pathogen and how well the tests are performing. Stenzel, who is the director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said the U.S. government agencies have made a number of grants for development of automated reporting mechanisms for at-home tests, signaling an interest on the FDA’s part that automated reporting capabilities will be a priority when the next pandemic strikes.
Springboarding off the success of its AI-based imaging software for cancer detection, the deep learning-based artificial intelligence (AI) company Lunit Inc. has another AI software, called the Lunit Scope, up its sleeve for which it hopes to gain U.S. FDA approval by 2025.
In a potential breakthrough for diagnosis and treatment development of liver disease, the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project demonstrated that a blood test could diagnose nonalcoholic steatohepatitis (NASH), an increasingly common liver disease in the U.S. The study, published in Nature Medicine, identified four biomarkers that outperform current liquid biopsies for NASH.
China’s recovery from its zero-COVID policy has failed to gain the momentum expected, with many experts predicting a slow or even negative growth rate. A slower economy, combined with a push toward self-reliance, bodes poorly for diagnostics manufacturers in the U.S. who may find themselves not just shut out of the huge market but facing stiffer competition around the globe. Further, policies designed to build a domestic next-generation sequencing industry have created headwinds for San Diego-based Illumina Inc. and others, noted Kyle Mikson and Alex Vukasin of Canaccord Genuity in an in-depth report.
At the same time it reported U.S. FDA clearance for bedside software to diagnose electrographic status epilepticus (ESE) seizures, Ceribell Inc. declared Claritypro the first ICU monitoring device to receive an NTAP reimbursement from the Centers for Medicare and Medicaid Services. The clearance of Claritypro to diagnose ESE follows receipt of an FDA breakthrough device designation in two different categories in the past year, setting the stage, Ceribell CEO Jane Chao told BioWorld, for expanded access to critical seizure diagnosis technology.
Nevia Bio Ltd. (formerly Gina Life Ltd.) completed a $3.1 million seed round that will allow the company, which has developed a platform that can decode biomarkers data from vaginal secretions for the early detection of ovarian cancer, to conduct clinical trials. With ovarian cancer the leading cause of death in women diagnosed with gynecological cancers, Nevia is hoping that its platform will save many lives.
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