Study determines reference interval cutoff for sIgG to Aspergillus fumigatus | PCT test does not help shorten antibiotic duration in children | Pancreatic cancer blood test enters clinical validation phase
ARUP Laboratories researchers have determined a reference interval cutoff for Aspergillus fumigatus serum-specific immunoglobulin G using the ImmunoCAP assay, finding 81.5 mcg/mL at the 97.5th percentile among healthy donors. The study, published in The Journal of Applied Laboratory Medicine, also suggested a 40.4 mcg/mL cutoff for precipitin positivity and 64.7 mcg/mL for pulmonary aspergillosis diagnosis.
Researchers from the Francis Crick Institute, University College London and Personalis have developed a test that predicts lung cancer outcomes by detecting circulating tumor DNA in blood. The study, funded by Cancer Research UK, showed that the NeXT Personal platform identified non-small cell lung cancer with high sensitivity, and lower ctDNA levels before surgery were linked to better survival rates.
A UK study involving nearly 2,000 children has found that using a procalcitonin blood test does not reduce the duration of intravenous antibiotic treatment compared with standard care. The study, part of the Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection trial, highlights the need for robust antimicrobial stewardship and clinician education to manage antibiotic use effectively.
An experimental blood test for pancreatic cancer developed by Van Andel Institute and the University of Pittsburgh has entered clinical validation with ReligenDx, a CLIA-accredited lab. The test outperformed the current standard in a recent study, identifying 71% of cancer samples compared with 44% by the standard test.
A Health Affairs study finds that 65% of US hospitals integrate AI or predictive models with electronic health records, but only 61% evaluate these models for accuracy and 44% for bias.
Roche has received FDA 510(k) clearance for the Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail, an assay that aids in diagnosing B-cell lymphoma. The test differentiates between B-cell malignancy and reactive infection responses, assessing over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single slide.
Revvity has received FDA clearance for its chemiluminescence-based immunoassay, marking the first approval for a test that directly and quantitatively measures free testosterone levels. The test, available through Revvity's EUROIMMUN, delivers results in 48 minutes and requires minimal technician training.
HMNC Brain Health has completed subject randomization for its Phase IIb OLIVE trial, which is evaluating the vasopressin V1b receptor antagonist BH-200, along with a companion diagnostic, for major depressive disorder in people with HPA-axis dysfunction.
Qiagen has received FDA clearance for the QIAstat-Dx Gastrointestinal Panel 2 Mini B\u0026V, which tests for five common causes of gastrointestinal illness using real-time PCR technology. The panel works with Qiagen's QIAstat-Dx syndromic testing analyzer to deliver results in about an hour.
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