Problem: Many clinical genetic and genomic labs knowingly or unknowingly take inappropriate shortcuts that may ultimately lead to mistakes in their test validations. These ‘mistakes’ can impact patient care and outcomes. With LDTs not being regulated,...
A recent article published in ProPublica has so much amazing information that we will be outlining today and tomorrow. Part 1 is below. Part 2 will be tomorrow. Happy reading! In 2020, the American College of Obstetricians and Gynecologists...
Problem: Verifying Accurate Leading-edge IVCT Development (VALID) Act is part of the December omnibus spending bill. If VALID doesn’t pass, how will LDTs be regulated to ensure patients are getting accurate results? Solution: The FDA could use...
“According to the Centers for Disease Control and Prevention, 70% of health care decisions are based on clinical lab tests. The potential for the future is even greater, with early detection and better treatment guidance, and opportunities for new targeted...
Recent Comments