Miscellaneous Diagnostic Tests

Fresenius Kabi Adds Additional Strengths to Adenosine Product Line

By July 11, 2018

Adenosine Injection, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

Pelvic Exam in ER Doesn't Help Predict STI for Young Females

July 10, 2018

A practitioner obtained a standardized history from the patient to assess for cervicitis or pelvic inflammatory disease; pelvic examination was performed by the same practitioner.

Patient Interest Fairly High for Melanoma Genetic Risk Testing

July 10, 2018

The researchers found that 232 of the 499 participants randomized to MC1R testing logged on to the website, and of these, 88% (204 participants) requested testing and 82% (167 participants) returned the test kit.

Handheld, Wireless Ultrasound Device SONON 300L Now Available

By July 09, 2018

The device is indicated for ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal, vascular, small parts (breast, thyroid), and lung imaging.

Post-Endoscopic Infection More Common Than Previously Thought

June 22, 2018

The rates of infections were compared with those after screening mammography, prostate cancer screening, bronchoscopy, and cystoscopy procedures.

AAFP Still Recommends CRC Screening From Age 50 to 75

June 21, 2018

The AAFP agrees with the USPSTF recommendation for screening patients at ages 50 to 75 years, and graded its recommendation B.

Cleared Blood Glucose Monitor Systems Not Always Accurate

June 19, 2018

"Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance," the authors write.

USPSTF: No to ECG Screening to Prevent CVD in Low-Risk Adults

June 13, 2018

The researchers found that it is very unlikely that the information from resting or exercise ECG would result in a change in a patient's risk category that would lead to a change in treatment or improve health outcomes for asymptomatic adults at low risk for CVD events.

New Coagulation Monitoring Device Allows for Wireless Reporting of INR Results

By June 11, 2018

The system is intended for properly selected trained users ≥22 years of age who have been stabilized on anticoagulation with vitamin K antagonists for ≥6 weeks.

ASCO: New Assays May Detect Early Lung Cancer in Blood

June 06, 2018

The researchers found that more than 50% of the 3,055 nonsynonymous mutations detected across 122 evaluable patients with lung cancer were detected in WBC consistent with clonal hematopoiesis.

Should Genealogy Data Be Used for Criminal Justice Purposes?

By May 30, 2018

Informed consent, privacy, and justice concerns are 3 issues that should be addressed before the use of online genealogy data in criminal cases becomes widely adopted.

Extended INR Test Intervals Safe for Warfarin-Treated Patients

May 23, 2018

Similar number of out-of-range next INR values for patients with, without extended testing interval

First Test to ID <i>Candida auris</i> Gets FDA Approval

By April 23, 2018

The Bruker Maldi system is already cleared for use in identifying 333 species or species groups, including 424 bacteria and yeast species.

FDA Approves Unique Device for Diabetic Retinopathy Screening

By April 11, 2018

This is the first device authorized for marketing that provides a screening decision without the need for clinician interpretation.

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%.

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).

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.

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.

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.

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.

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

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

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.

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.