New research highlights the benefits of multianalyte assays with algorithmic analyses to guide treatment of women's health issues, including breast cancer and preeclampsia. MAAAs use an algorithm to combine two or more biochemical or molecular markers, as well as patient information and demographics, to provide a personalized risk assessment.
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Triglycerides in low-density lipoprotein cholesterol may predict cardiovascular events and are associated with genetic variants, researchers reported in the Journal of the American College of Cardiology. "Our next step will be to see how lifestyle modifications or medications affect LDL-TG levels and if that affects outcomes of cardiovascular disease," said Baylor College of Medicine researcher Anum Saeed.
Researchers at University of Texas Southwestern Medical Center found that tau molecules associated with Alzheimer's disease change shape before attaching to other tau proteins and enabling tau tangle formation, and aren't indistinctly shaped and harmful only when attached to other tau proteins, as previously believed. The findings in the journal eLife may allow early Alzheimer's detection and has prompted the development of therapies aimed at balancing tau before they change their shape, researchers said.
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Israel-based medical devices startup Sight Diagnostics has released in Europe the OLO point-of-care blood diagnostics system, which allows AI-powered blood testing to be done in a doctor's office. The system, which the company hopes to get FDA approval for next year, digitizes blood into specifically colored microscope images and determines and counts blood cell types using proprietary machine vision algorithms.
The FDA has granted Quidel 510(k) clearance for its Solana Bordetella Complete Assay, a molecular diagnostic test designed for detecting and differentiating whooping cough-causing Bordetella species collected on nasopharyngeal swabs. The assay operates on the company's Solana system that uses helicase-dependent amplification and allows up to 12 samples to be processed for every batched run.
Roche Holding has secured expanded clearance from the FDA for its Elecsys BRAHMS PCT assay for use in antibiotic treatment decisions. The electrochemiluminescence immunoassay, which measures serum or plasma levels of procalcitonin, was previously cleared for assessment of progression to septic shock and severe sepsis, as well as 28-day post-diagnosis mortality.
Kypha, a St. Louis-based diagnostics firm that makes biomarker tests for the assessment of immune status and inflammation, has paid an undisclosed amount for Biosensia, an Irish diagnostics platform and contract-development company. The acquisition makes Biosensia, developer of the RapiPlex point-of-care diagnostic system, a wholly owned subsidiary of Kypha.
XaTek's series A financing round has brought in $9.1 million to further development of a device that can quickly analyze blood clotting ability with a single drop. The device, called ClotChip, will now be tested in clinical trials.
There's growing need to monitor of immunosuppressed patients with ultra-sensitive diagnostic tools that can identify HBV reactivation. Join Patricia Slev, PhD on July 26 as she discusses current testing algorithms and the latest Hepatitis B virus guidelines.