Miscellaneous Diagnostic Tests

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.

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 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.

Can DNA 'Liquid Biopsy' Diagnose Hepatocellular Carcinoma?

October 17, 2017

"Together, these findings demonstrate in a large clinical cohort the utility of ctDNA methylation markers in the diagnosis, surveillance, and prognosis of HCC," write the authors.

New Therapeutic Drug Monitoring Test for Ustekinumab Announced

By October 16, 2017

By measuring drug and antibody concentrations physicians can adapt treatment strategies and guide patients toward more personalized medicine.

Noninvasive Test Monitors Healing Status in Crohn's Disease Patients

By October 16, 2017

The PROMETHEUS Monitr Crohn's Disease test can be used as an adjunct to endoscopy or by itself between endoscopies.

Test to Detect Zika in Blood Donations Gets FDA Approval

October 10, 2017

Not designed to diagnose the infection, however

Survey Reveals Impact Medical Errors can Have on U.S. Patients

October 06, 2017

Ambulatory settings are a frequent site of medical errors, and the most commonly reported errors were related to diagnosis and patient-provider communications.

Potential Prognostic Biomarker ID'd for Triple-Negative Breast CA

September 26, 2017

African-American patients harbored significantly more tumor-infiltrating lymphocytes than European Americans among early-stage (I to II), but not late-stage (III to IV), patients.

USPSTF: Cervical Cancer Screening Recommendations Issued

September 13, 2017

For women aged 21 to 29 years, the USPSTF recommends screening for cervical cancer with cervical cytology alone every 3 years. For women aged 30 to 65 years, the USPSTF recommends screening every 3 years with cervical cytology alone or every 5 years with hrHPV testing alone (A recommendation).

Current Diagnostic Tools Failing to ID Bacterial Infections in Infants

September 12, 2017

Sensitivities were low for common complete blood cell count thresholds: white blood cell count <5,000/µL, 10%; white blood cell count ≥15,000/µL, 27%; absolute neutrophil count ≥10,000/µL, 18%; and platelets <100 × 10³/µL, 7%.

Mammography Device with Patient-Assisted Compression Gets FDA Approval

By September 05, 2017

Using a handheld wireless remote control, the patient can adjust the compression force after breast positioning by a technologist.

Sefria Fentanyl Screening Test Gets FDA Clearance

By August 03, 2017

The test has demonstrated cross-reactivity with acetyl fentanyl, butyryl fentanyl, despropionyl fentanyl, and sufentanil.