EMERGING TESTS

POC Susceptibility Testing No Aid for Antibiotic Prescribing with UTI

Adding point-of-care (POC) susceptibility testing to POC culture does not improve appropriateness of antibiotic prescribing for patients with suspected, uncomplicated urinary tract infection (UTI) in … [Read more...]

TESTING TRENDS

Teaching Hospitals Consistently Order More Lab Tests Per Patient

A new study validates the long-held assumption that intensity of care is consistently higher at teaching hospitals, compared to nonteaching hospitals. Patients in Texas admitted to major teaching … [Read more...]

INDUSTRY TRENDS

FDA’s Two Big Moves on NGS-Based Tumor Panels May Offer Clues for Alternative Pathways for LDT Approval

In late November the U.S. Food and Drug Administration (FDA) authorized Memorial Sloan Kettering Cancer Center's Integrated Mutation Profiling of Actionable Cancer Targets tumor profiling test assay … [Read more...]

TOP OF THE NEWS

LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common

One of the arguments for U.S. Food and Drug Administration oversight over laboratory-developed tests (LDTs) involves the need for greater assurances regarding the quality and consistency of these … [Read more...]

GUIDELINES

FDA Warns About Biotin Interference With Lab Tests

In late November the U.S. Food and Drug Administration issued a safety communication warning that the supplement biotin (Vitamin B7) may interfere with laboratory testing results. The warning comes … [Read more...]

LAB SAFETY

Pediatric Offices Fail to Act on 1 in 10 Abnormal Test Results

Diagnostic errors (DEs) and missed opportunity for diagnosis (MOD), including the failure to act on abnormal laboratory test results in a timely manner, commonly occur in pediatric primary care … [Read more...]

PUBLIC HEALTH

Foster Kids’ Standard Screenings Tests May Be of Low Value

Routine laboratory screening for children entering foster care may be costly given the low diagnostic yield, according to a study published in the December issue of Pediatrics. The authors suggest … [Read more...]

GUIDELINES

AMP Issues Consensus Guidelines for NGS Bioinformatics Pipelines

The Association for Molecular Pathology (AMP) published 17 consensus recommendations for the validation of clinical next-generation sequencing bioinformatics pipelines. The report, "Standards and … [Read more...]

INDUSTRY TRENDS

FDA Continues Easing DTC, Home Use Test Regulations

In a continued reversal of its 2013 crackdown on direct-to-consumer (DTC) genetic tests, the U.S. Food and Drug Administration (FDA) unveiled loosened regulations in November that will effectively … [Read more...]

EMERGING TESTS

Novel Tests Emerging For Overlooked Conditions

Undeniably, much of the emerging test focus is on cancer and infectious diseases. DTET wants to showcase other novel tests entering the marketplace. What follows is a sampling of novel tests entering … [Read more...]


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