The U.S. FDA reported a pilot program for validation of lab-developed tests (LDTs) used as companion diagnostics, a move that seems an implicit recognition that test kits as CDx products are not the darlings of test developers. The program arrives as the agency is considering rulemaking for regulation of LDTs, however, a combination of developments that promises to roil the already strained relationship between the FDA and clinical labs.
A method for manufacturing graphene which significantly increases its electrochemically active surface area holds the potential to reduce the cost and increase the accuracy of biosensors and could provide the basis for amplification-free, label-free and enzyme-free in vitro diagnostics.
Difficulty in obtaining an accurate diagnosis and treatment for endometriosis leaves many women spitting mad, but they may soon find that saliva is the key to escaping the diagnostic maze. A recent study published in the New England Journal of Medicine validated the Endotest developed by Ziwig SAS based on results from a study involving 200 symptomatic patients monitored in five hospital units and specialized centers in France since November 2021. The findings demonstrateda sensitivity and specificity of more than 95%.
A new study from Dana Farber Cancer Institute, Brigham and Women’s Hospital and Poland’s Medical University of Lodz suggests a simple blood test could detect ovarian and breast cancer without the need for genetic sequencing, paving the way for broader and less costly screening campaigns.
Stephanix SAS and Incepto Medical SAS reported signing a strategic partnership at the annual congress of the French association for female medical imaging (SIFEM) in Bordeaux. The companies are joining forces by way of a distribution agreement to improve the medical imaging available in France.
The early detection of chronic liver disease (CLD) could help in the prevention of cardiovascular diseases (CVD), according to a study published in the Journal of Hepatology. Using Perspectum Ltd.’s Livermultiscan, a noninvasive MRI scan, researchers analyzed liver data and found that liver disease activity measured by MRI corrected T1 (cT1) is associated with higher risk of major CVD events.
Exact Sciences Corp. demonstrated a significant increase in accuracy with the latest version of its Cologuard test for colorectal cancer in its pivotal BLUE-C study. Top-line results released this week showed that the next-generation test exceeded the specificity and sensitivity seen in the DEEP-C study that underpinned U.S. FDA approval of the commercially available version of Cologuard, a stool-based assay.
In a wise move from Owlet Inc.’s point of view, the U.S. FDA cleared the company’s Babysat pulse oximetry sock for infants. The wire-free sock design permits safe and comfortable medical-grade monitoring for infants who might otherwise require extended hospitalization.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
Anumana Inc. has garnered a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-powered electrocardiogram-based algorithm for early identification of cardiac amyloidosis. The ECG-AI detection algorithm is the fourth from the company and its partners to notch breakthrough status.
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