Diagnostic Agents

First Tests to Screen for Babesiosis in Whole Blood, Plasma Approved

By March 07, 2018

These tests are intended to screen samples from individual human donors, including volunteers who give whole blood and blood components, as well as living organ and tissue donors.

FDA Authorizes First Direct-to-Consumer BRCA Mutation Test

By March 06, 2018

According to a National Cancer Institute study about 2% of Ashkenazi Jewish women carry 1 of the hereditary mutations the test can detect. Among other ethnic populations this occurrence is only 0% to 0.1%.

Early dermatology consultation linked to improved diagnostic accuracy and care in cellulitis

February 28, 2018

Among patients admitted to the hospital for a provisional diagnosis of cellulitis, early dermatologic consultation was associated with improved recognition of pseudo-cellulitis, decreased antibiotic use, and earlier discharge.

Dermoscopic Criteria Accuracy Assessed in Diagnosing Melanoma in Situ

February 23, 2018

The researchers found that 25.3% of the lesions were MIS. The most frequent dermoscopic criteria for MIS were regression, atypical network, and irregular dots and/or globules (92.9, 85.5, and 50.2%, respectively).

Kurtosis Diffusion-Weighted Imaging May Reduce False Positive Mammographies

February 23, 2018

At the predefined sensitivity of greater than 98.0%, the researchers found that the radiomics feature model reduced false-positive results from 66 to 20 in the independent test set (specificity, 70.0%); BI-RADS 4a and 4b lesions benefited from the analysis (74.0 and 60.0%, respectively).

New Test May Help Diagnose Autism Earlier in Children

By February 20, 2018

In this study, researchers explored the association of proteotoxic damage with autism spectrum disorder.

First Blood Test to Assess Concussion in Adults Gets FDA Approval

By February 15, 2018

Banyan BTI (Brain Trauma Indicator) is an in vitro diagnostic blood test to aid in the evaluation of patients with suspected TBI.

FDA: New Clinical Decision Support Tool Helps ID Stroke Sooner

By February 14, 2018

The Viz.AI Contact application is a computer-aided triage software that uses an artificial intelligence algorithm to analyze images for indicators associated with a stroke.

FDA: 'Groundbreaking' Approval Enables Domestic Supply of Critical Medical Isotope

February 09, 2018

New technology approved to produce the country's own supply of the radioisotope Technetium-99m

Risk of Appendicitis Measured Following Colonoscopy

January 31, 2018

More frequent codes for appendicitis, appendectomy in week after colonoscopy versus next 51 weeks. This result was not affected by age subgrouping, and there was no increase in appendicitis in weeks two to four.

FDA Expands Pediatric Age Range for MultiHance Contrast Agent

By January 30, 2018

The FDA's approval was supported by data specifically gathered in patients aged <2 years. The 0.1mmol/kg dose significantly improved the visualization and morphologic assessment of CNS lesions as seen in older pediatric patients and adults.

Specific White Matter Patterns Linked to Youth Psychopathology

January 29, 2018

The feature most associated with both of these traits was a brain white matter pattern reflecting frontotemporal connectivity and crossing fibers in the uncinate fasciculus.

MRI Diagnostic for Differentiating Low-Grade Bladder Cancers

January 29, 2018

Across studies, the pooled sensitivity of MR imaging was 0.90 and the specificity was 0.88 for differentiating tumors staged T1 or lower from those staged T2 or higher.

Personalized Genetic Test May Estimate Age of Prostate CA Diagnosis

January 12, 2018

"Polygenic hazard scores can be used for personalized genetic risk estimates that can predict for age at onset of aggressive PCa," the authors write.

FDA Clears UriVarx Test Strips for UTI Detection

By January 11, 2018

The supplements are intended to reduce urinary urgency, accidents, and day/night frequency in patients with overactive bladder and urinary infections.

Delta CHA<sub>2</sub>DS<sub>2</sub>-VASc May Forecast Stroke Likelihood More Accurately

January 09, 2018

The Delta CHA2DS2-VASc score significantly better predicted ischemic stroke compared to baseline or follow-up CHA2DS2-VASc scores

FDA: New Class Warning for All Gadolinium-Based Contrast Agents

By December 19, 2017

Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function.

Payment Cuts for Office-Based Point-of-Care Testing Take Effect Jan. 1, 2018

December 18, 2017

CMS Clinical Laboratory Fee Schedule to result in drop in payments for physician office-based tests

Accuracy of Artificial Intelligence Assessed in CA Diagnosis

December 12, 2017

The researchers found that the AUC of the DLS for referable diabetic retinopathy was 0.936, and sensitivity and specificity were 90.5 and 91.6%, respectively

Blood Glucose Meter Compatibility with Test Strips

December 07, 2017

Blood Glucose Meter Compatibility with Test Strips chart

First Flushable Pregnancy Test Cleared for OTC Use

By December 05, 2017

The Lia Pregnancy Test is made with the same plant based fibers as most toilet paper and weighs less than 6 squares of the leading 3-ply toilet paper.

New Study Sheds Light on Safety of Gadolinium-Based Contrast Agents

By November 29, 2017

After adjusting for gender, age, education level, baseline neurocognitive performance, and others, the authors reported gadolinium exposure was not a significant predictor of cognitive decline, dementia, diminished neuropsychological performance or diminished motor performance

FDA: Vitamin May Interfere With Lab Tests, Already One Fatality Reported

By November 28, 2017

The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.

FDA Approves InSure One to Aid in Detecting Lower GI Bleeding

By November 13, 2017

The InSure ONE requires a sample of water from the toilet bowl, after the stool surface has been brushed to release any blood.

Soluble Interleukin 2 Receptor Assessed as Biomarker of Sarcoidosis in Uveitis

November 13, 2017

To compare the value of soluble interleukin 2 receptor (sIL-2R) with ACE as diagnostic biomarkers of sarcoidosis in patients with uveitis.

New Immunoassays Show Improvement in Measuring A&#946;42 in CSF

November 09, 2017

The researchers found that the mass spectrometry-derived Aβ42 values showed higher correlations with the modified Aβ42-INNOTEST, Aβ42-FL, Aβ42-EI, and Aβ42-MSD assays versus the classic Aβ42-INNOTEST assay.

New CBC Test Allows for Testing in More Settings, Reduced Processing Time

By November 06, 2017

This broadened test access will allow for faster availability of results.

Two Simple Tests May Help PCPs Identify Fibromyalgia

November 01, 2017

"These results suggest that two tests, taking less than one minute, can indicate a probable diagnosis of FM," write the authors.

Three Antimicrobial Susceptibility Tests Approved for Baxdela

By October 30, 2017

The newly cleared ASTs include: Hardy Diagnostics' Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk), Liofilchem Delafloxacin MIC Test Strip (MTS), and Thermo Scientific Sensititre MIC System.