A new acute coronary syndrome detection system developed by Neuome Peptides Pte. Ltd.’s aims to make tests for the frequently lethal condition faster, more precise and less invasive. Neuome’s Truheart is a point-of-care assay for cardiovascular disease that is used in the company’s established Instadetect assay development platform. The assay measures the biomarkers troponins I and T and myoglobin.
Earlysight SA is developing a novel ophthalmology device that can be used to diagnose certain degenerative eye disorders long before onset of first symptoms. Earlysight and researchers at the Swiss Federal Institute of Technology Lausanne (EPFL) have reported positive results for their first clinical trial of Cellularis in the journal Ophthalmology Science.
U.S. federal authorities have made a lot of noise over inappropriate medical testing in the past two years, largely due to the COVID-19 pandemic, but Paul Garcia, a partner in the San Diego office of Hooper, Lundy & Bookman PC, says this trend will not ebb at all in the coming year. Garcia told BioWorld that the lookback period for Medicare testing claims runs several years and that not only will enforcement results continue to surface next year, but also that the associated civil monetary penalties could force a testing lab to shutter its operations permanently.
Fujifilm Corp. inked an agreement to purchase the global digital pathology business of Inspirata Inc., paving the way for expansion of its Synapse enterprise imaging offering. The transaction includes Inspirata’s Dynamyx software, which Fujifilm has distributed in the U.K. and certain European Union countries since mid-2020. Under the agreement, Fujifilm will acquire Inspirata’s digital pathology technology, as well as employees and customers associated with the brand. Financial terms of the deal were not disclosed. It is expected to close in early 2023.
Cofactor Genomics Inc. opened the non-small-cell lung cancer portion of its study of the Oncoprism test, which predicts response to immunotherapy. The Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies (PREDAPT) trial will study the test’s predictive ability in 11 cancers in total.
Guardant Health Inc. reported positive results from the ECLIPSE trial demonstrating 83% sensitivity of its DNA blood test in detecting colorectal cancer (CRC) in average-risk adults. Specificity was 90% in people without advanced neoplasia, as well as in those who had a negative colonoscopy result.
A feasibility study conducted by the University of Queensland (UQ) confirmed the utility of Inoviq Ltd.’s exosome-based ovarian cancer screening test for isolating extracellular vesicle (EV) biomarkers. The Ovarian Cancer 97 study (OC97) screened data from 97 plasma samples and identified significant differences between the EV biomarker content of ovarian cancer and healthy control samples.
Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13.
Olive Diagnostics Pvt. Ltd. is looking to raise $10 million in a series A funding round to extend sales and marketing activities, after getting CE approval for its urine analysis device that mounts on any toilet. Among other parameters the device, Olive KG, can measure red blood cells, proteins, nitrates, pH levels volume, pressure and frequency of urination.
What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
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