TESTING TRENDS

Methods for Reanalysis of Exome Sequencing Emerging

Clinical whole-exome sequencing (WES) offers diagnosis for approximately 30 percent of patients, but it has exponentially increased the number of variants identified—many of which are of unknown … [Read more...]

INDUSTRY TRENDS

Evidence for Liquid Biopsy Lacking, Expert Panel Finds

There is not enough evidence, currently, to support the routine adoption of liquid biopsy tests for any of its promising clinical uses, according to a joint review published March 1 in both the … [Read more...]

INDUSTRY TRENDS

Next-Gen Sequencing, AI Driving Investor Interest in Diagnostics Sector

There is "intense" investor interest and "substantial" investment occurring in the next generation of diagnostics and tools companies (Dx/Tools), according to a year-end report … [Read more...]

TESTING TRENDS

Molecular Testing Increasingly Adopted for Skin Cancer Diagnosis

Dermatopathologists are increasingly using molecular testing for diagnosis of skin cancer samples. Yet, this adoption remains more concentrated in academic medical centers and high-volume clinical … [Read more...]

INDUSTRY TRENDS

Internet-Based Testing for STIs Increase Uptake

Providing internet-based testing for sexually transmitted infections (e-STI testing) could increase the number of people being tested for syphilis, HIV, chlamydia, and gonorrhoea, including among … [Read more...]

INDUSTRY TRENDS

Venture Capital Investment in Diagnostic Companies Strong in 2017

Venture capital investments in health care innovation reached an all time high in 2017, including in diagnostics/tools (Dx/Tools) companies, according to Silicon Valley Banks' preliminary 2018 … [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...]

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...]

HEALTH CARE REFORM

High-Deductible Plans Tied to Reduced Use of Health Care, Including Diagnostic Testing

People enrolled in high-deductible health plans (HDHPs) cut their use of health services, including laboratory testing, according to a study published in the October issue of Health Affairs. HDHPs … [Read more...]


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