FDA

FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests

While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul. For several years, the FDA, Congress and lab industry have been working together … [Read more...]

FOCUS ON

How the Opioid Crackdown Is Affecting Lab Enforcement & Test Utilization

103 in 1: Odds of dying in a motor vehicle crash 96 in 1: Odds of dying from an opioid overdose The alarming finding that a person is now more statistically likely to die of an opioid overdose … [Read more...]

CAPITAL

Investment Trends: Dx/Tools Venture Capital Keeps Flowing Despite Decline in Early-Stage Investment

Continuing a four-year trend, total U.S. venture capital investment in health care surged in 2018, reaching a new all-time high of $9.6 billion, according to Silicon Valley Bank's (SVB) Trends in … [Read more...]

NEWS

New Study Finds Lab Automation Market Poised for Continued Growth, Focus on Genomics Solutions

The lab automation market is expected to reach $5.20 billion by 2022 from an estimated $4.06 billion in 2017, at a CAGR rate of 5.1%, according to leading B2B research company MarketsandMarkets. The … [Read more...]

NEWS

Inside the Lab Industry: 5.1% Growth Expected to Lift Lab Automation Market to $5 Billion by 2022

Projected compound annual growth of 5.1% will take the lab automation market from its current $4.06 billion (2017) to $5.20 billion by 2022. The Study This is the finding of a new study on the lab … [Read more...]

INDUSTRY TRENDS

Diagnostics Sector Saw Increased Investment, Exits in 2018

Life science and health care companies had a banner year in 2018, with a record-breaking year for venture capital investment, according to Silicon Valley Bank's Trends in Healthcare Investments and … [Read more...]

MARKETING

Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service

The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect 33 variants for multiple … [Read more...]

PRECISION MEDICINE

Panel Size Affects Accuracy of Tumor Mutational Burden Calculation

Panel size is a critical determinant of test performance and cutoff values for determining the tumor mutational burden (TMB) to guide treatment decisions with immunotherapies, according to a study … [Read more...]

INNOVATION

Using Digital Technology and AI to Fight Cancer

It has the makings of a Hollywood movie. Three recent college grads start a medical testing software company that uses a digital pathology platform, meet with success, and then go on to utilize … [Read more...]

MARKETING

Industry Trends: Continued Momentum for Lab-Retail Collaboration

The Theranos debacle hasn't dissuaded retailers from partnering with labs. Here's a rundown of some recent deals. LabCorp & Walgreens In fact, Walgreens, Theranos's ex-retail partner, has moved … [Read more...]


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