Clinical labs are not usually the stuff of Hollywood. But the story of Theranos and its charismatic leader has attracted filmmakers the way regular law-abiding labs never do, spawning not one but a … [Read more...]
FDA
FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
March 11, 2019
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
February 18, 2019
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
February 5, 2019
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
February 5, 2019
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
January 30, 2019
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
January 28, 2019
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
January 14, 2019
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
December 17, 2018
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
December 17, 2018
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...]
