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...]
CAPITAL
Investment Trends: Dx/Tools Venture Capital Keeps Flowing Despite Decline in Early-Stage Investment
February 5, 2019
INDUSTRY BUZZ
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
January 28, 2019
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]
INDUSTRY BUZZ
Earnings Report: Top Payers Announce Q3 Earnings
January 7, 2019
The country's five largest commercial payers posted strong results for the third quarter of fiscal year 2018: COMPANY QUARTERLY REVENUES PERFORMANCE Total Q3* 2018 YOY Wall … [Read more...]
INDUSTRY BUZZ
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
December 31, 2018
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]
DATA
6 Steps to Data-Driven Transformation
November 26, 2018
By Nir Kaldero bio We're now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the Third brought … [Read more...]
INDUSTRY BUZZ
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
November 19, 2018
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use. The agency changed its email communications policy on … [Read more...]
PAMA
Medicare Reimbursement: Part B Lab Payments in Final Year before PAMA
November 5, 2018
Part B payments for lab tests in 2017, the final year under the old reimbursement rules, totaled $7.1 billion, up slightly from the $6.8 billion Medicare paid in 2016 and little changed over the … [Read more...]
INDUSTRY BUZZ
FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry
October 2, 2018
The lab industry played an active role in the drafting of the Diagnostic Accuracy and Innovation Act (DAIA), a bill designed to establish a new regulatory regime for laboratory developed tests (LDTs). … [Read more...]
TECHNOLOGY
Artificial Intelligence: An Automated New World for Labs & Pathology
October 1, 2018
Artificial intelligence (AI) and machine learning are making significant inroads in the diagnostics realm. Here are four ways the technology is changing the field and the business of pathology. 1. … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary
August 1, 2018
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No … [Read more...]
