University of Utah and Sloan Kettering Institute Study Sheds Light on How the Body Recognizes “Good” from Bad Bacteria in the Microbiome

Researchers found that early in life intestinal microorganisms “educate” the thymus to develop T cells; findings could lead to improved immune system therapeutics and associated clinical laboratory tests Researchers at the University of Utah and the Sloan Kettering Institute (SKI)—the experimental research division of the Memorial Sloan Kettering Cancer Center (MSKCC) in New York—have uncovered new insights into how the immune system learns to distinguish between harmful infectious bacteria...

FDA Approves Digital Therapeutics Technologies to Treat Patient Behavioral Conditions That Interfere with Positive Healthcare Outcomes

Clinical laboratories with strong digital and information technology capabilities may find opportunities in this growing field of healthcare Digital therapeutics (DTx), a growing trend in life sciences technology, is emerging as a popular form of connected healthcare physicians can use to transform patient behavior and improve clinical outcomes. This development may create opportunities for IT-savvy clinical laboratories. The software applications (apps) and hardware monitoring devices...

Solutions to the Problems of Rural Hospitals Must Address the Need for Adequate Clinical Laboratory and Anatomic Pathology Testing Services

One idea proving attractive to health policymakers is putting a hybrid model into rural towns that includes a freestanding emergency department and primary care Times are tough for rural hospitals and officials in many states are looking at new models for healthcare delivery in rural areas. Anatomic pathology groups with contracts to serve rural hospitals will be affected by any changes in how rural hospitals are funded and operated. One suggested approach to replace the existing community...

FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs. UDIs also will apply to certain combinations of products that contain devices...

Doctors’ Mistakes in Genetic Test Orders Is Warning Signal to Pathologists and Clinical Laboratories

Clinical laboratory professionals and pathologists should be aware of significant levels of errors in clinician gene test orders Almost one-third of medical laboratory test orders for complex gene tests contained mistakes in handling by ordering clinicians. This finding comes from a study by ARUP Laboratories, Inc.. The finding is an early warning flag for pathologists and clinical laboratory professionals that a gap exists between the availability of genetic tests and clinician knowledge of...
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