FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development

While it’s too soon to say what effect the Food and Drug Administration (FDA) decision to move forward with plans to regulate lab-developed tests (LDTs) will have on clinical and anatomic pathology … [Read more...]

Lab Execs Air Concerns Over FDA Regulation of LDTs

The U.S. Food and Drug Administration (FDA) late last week officially issued its draft framework for how the agency plans to regulate laboratory-developed tests (LDTs). The 41-page framework, which … [Read more...]

Focus on: Lab Institute: Labs Need to Realign Approach to Diagnostic Services By Focusing on Physician, Patient Engagement

The future of the diagnostic laboratory industry was on everyone’s mind as more than 500 people from clinical and anatomic pathology laboratories and related industries gathered in Washington, D.C., … [Read more...]

Bostwick Laboratories Settles Whistleblower Case for $6 Million

Bostwick Laboratories (Uniondale, N.Y.) will pay more than $6 million to settle a whistleblower lawsuit alleging the lab inappropriately billed federal health programs for laboratory tests. The qui … [Read more...]

Closely Scrutinized Health Diagnostic Laboratory Cuts 15 Percent of Its Workforce

Exactly a year ago, Health Diagnostic Laboratory (HDL) founder and Chief Executive Officer Tonya Mallory talked at length to G2 Intelligence about the remarkable success of her company, which grew … [Read more...]

EBOLA Continues to Warrant Attention From Labs

While public interest and mainstream media coverage of Ebola may appear to be waning, the outbreak has not ended and the latest CDC reports indicate the total cases exceeds 20,000 and is still rising. … [Read more...]