INDUSTRY BUZZ

Improved Accuracy of Point-of-Care HbA1c Tests May Expand Access to Testing

Good news for Abbott and its newly acquired Alere Technologies: A new study published in the Journal of Diabetes Science and Technology finds that the latter's POC Afinion HbA1c Dx test is accurate … [Read more...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]

INDUSTRY BUZZ

FDA Watch: Gottlieb Resignation Costs Lab Industry a Valuable Frenemy

Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. Although his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]

LEADERSHIP

Communication: Managing Amid Change

Greek philosopher Heraclitus said the only thing constant is change. Although he never managed a diagnostic laboratory, his words certainly apply to the lab environment. Like other facets of … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results

On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to market. Under the "Safety and Performance Based Pathway" (new Pathway), new product … [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...]

INDUSTRY BUZZ

FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review

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

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

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

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...]


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