CAP showcases labs accredited for over 50 years June 24, 2019 -- The College of American Pathologists (CAP) has published a list of 41 laboratories that have continuously completed its voluntary accreditation program for quality and proficiency standards since the program's inception in 1964.
CAP warns about loss of access to pathology June 21, 2019 -- The College of American Pathologists (CAP) is warning that patients may lose access to pathology services through provisions of the Lower Health Care Costs Act proposed by the U.S. Senate Committee on Health, Education, Labor, and Pensions.
Is blood testing for vitamin D a waste of money? June 19, 2019 -- The debate about the overuse of blood testing for vitamin D and the effect on the U.S. health system -- as well as on smaller diagnostic labs with limited resources to meet the high demand -- is rekindled in a large meta-analysis and editorial published in JAMA Cardiology on June 19. Discuss
LIMS software makes strides in labs, draws new adopters June 18, 2019 -- Our phones, watches, and even houses have become smarter over the past decade, and new software features are now also enabling laboratories to upgrade their IQs. Although the market for laboratory information management systems (LIMS) and other applications has been mature for several years now, new functionality is enabling disruptive changes, writes market analyst Ryan Harake. Discuss
FDA sets standards for biotin lab tests June 13, 2019 -- The U.S. Food and Drug Administration (FDA) published draft guidance on June 13 that sets new standards regarding interference from vitamin B7, also called biotin, in IVD tests. Biotin technology is used in many medical diagnostic products, including hormone and troponin testing.
Will new HIV recommendations boost test volume? June 11, 2019 -- New recommendations released June 11 from the U.S. Preventive Services Task Force continue to strongly advise HIV screening for adolescents and adults, and for the first time they support preventive treatment for those at high risk. The guidance could boost volume for blood tests. Discuss
How to prepare for FDA's device cybersecurity update June 11, 2019 -- Connectivity, interoperability, and electronic data exchange are important technological advancements, but they also bring security concerns for manufacturers and users of in vitro diagnostics and other clinical lab equipment. The U.S. Food and Drug Administration (FDA) issued draft premarket cybersecurity guidance that updates recommendations for device manufacturers on how they can protect their products against different types of cybersecurity risks. Discuss
AMP's stance on consumer tests gets makeover June 10, 2019 -- The Association for Molecular Pathology (AMP) has broadened the criteria it wants to see for clinically meaningful genomic tests for consumers in an updated position statement published on June 10.
Quest discloses hacking of 12M customer records June 3, 2019 -- Quest Diagnostics on June 3 disclosed that the records of nearly 12 million of its customers may have been hacked, potentially revealing personal information including financial data and Social Security numbers.