Analysis of DNA copy number variants (CNVs) in the cells exfoliated in urine showed better sensitivity and similar specificity in detecting urothelial carcinoma compared with urine cytology. Urine ...
Pearl Diagnostics Announces FDA 510(k) Clearance for Groundbreaking MycoMEIA Aspergillus Urine Assay
BALTIMORE--(BUSINESS WIRE)--Pearl Diagnostics proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the MycoMEIA ® Aspergillus Assay – the first ...
Researchers have shown that analyzing dried urine extracts with GC-MS/MS to assess levels of reproductive hormones in pre-and post-menopausal women provides similar results to radioimmunoassays using ...
(Nanowerk News) Researchers at Nagoya University in Japan have used a new device to identify a key membrane protein in urine that indicates whether the patient has a brain tumor. Their protein could ...
Measurement of an enzyme level (telomerase activity) in urine appears useful for detection of bladder cancer in men, according to a study in the October 26 issue of JAMA. The incidence of human ...
A new study suggests that a urine-based biomarker test shows promise in forecasting bladder cancer treatment response, which ...
The 510(k) clearances were granted to a dozen in vitro diagnostic tests and reagents which used a variety of detection methods and approaches.
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