New At-Home CBC Device Enables Complete Blood Testing for Cancer Treatments and Biological/Viral Monitoring

Chronic disease monitoring at home has become a boon to patients as well as hospitals that are finding cost savings in programs designed to monitor/treat patients at external locations Many clinical pathologists and medical laboratory scientists will be wary about the news that a California company wants to have cancer patients do their own CBCs at home, and  that a device to enable such testing is being prepped to go through the FDA clearance process. Home-based medicine care and chronic...

Direct-to-Consumer Clinical Laboratory Test Developer, EverlyWell, Receives $1 Million in Funding from Shark Tank Investor

Direct-to-consumer medical laboratory testing company gets a major shot in the arm as developers find ready investors and increasing consumer demand Clinical laboratory tests, usually performed without fanfare, were thrust into the limelight during a recent episode of Shark Tank, an American reality TV show on which aspiring entrepreneurs compete for the attention and partnership funds of various investors. EverlyWell, a direct-to-consumer (DTC) company that offers at-home lab tests without...

Anatomic Pathologists Who Work in Independent Reference Laboratories Can Now Provide Diagnostic Services for CLIA-Approved Hospitals without Need for Additional Credentialing and Privileging

The Joint Commission’s recent alteration to the Introduction to Leadership (LD) Standard LD.04.03.09 makes it easier for off-site and independent reference laboratories to service CLIA-hospitals and other CLIA-approved healthcare facilities Anatomic pathologists working for reference laboratories can now provide diagnostic services to hospitals, critical-access hospitals, and ambulatory care facilities in the US based on the organization’s Clinical Laboratory Improvement Amendments (CLIA)...

Severe Lack of Volunteers for Clinical Laboratory Studies Has US Alzheimer’s Researchers Employing Innovative Methods to Recruit Participants

Low interest and a lack of diversity among study participants hinders research into one of America’s most fatal and costly chronic diseases Finding enough people to participate in clinical laboratory trials for Alzheimer’s disease can be a daunting task for researchers. The shortage of participants has compelled scientists to develop innovative ways to locate volunteers for their studies. That includes “Swab-a-Palooza” events to make it easy for individuals to provide samples for this research...

Johns Hopkins University Study Finds Laboratory-Developed Liquid Biopsy Tests Can Give Different Results; Call for ‘Improved Certification’ of Medical Laboratories That Develop These LDTs

Liquid biopsy tests hold much promise. But inconsistencies in their findings provoke scrutiny and calls from researchers for further development before they can be considered reliable enough for diagnostic use Many commercial developers of liquid biopsy tests tout the accuracy and benefits of their diagnostic technology. However, there are an equal number of medical laboratory experts who believe that this technology is not yet reliable enough for clinical use. Critics also point out that...