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...

Sales of Direct-to-Consumer Clinical Laboratory Genetic Tests Soar, as Members of Congress Debate How Patient Data Should be Handled, Secured, and Kept Private

Direct-to-consumer (DTC) genetic testing has been much in the news of late and clinical laboratories, anatomic pathology groups, and biomedical researchers have a stake in how the controversy plays out. While healthcare consumers seem enamored with the idea of investigating their genomic ancestry in growing numbers, the question of how the data is collected, secured, and distributed when and to whom, is under increased scrutiny by federal lawmakers, bioethicists, and research scientists....

New FDA Regulations of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences for Medical Laboratories

Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools...

Lab-on-a-Fiber Technology Continues to Highlight Nano-Scale Clinical Laboratory Diagnostic Testing in Point-of-Care Environments

Ever shrinking “lab-on-a-…” technologies, a boon to medical laboratories and anatomic pathologists in remote resource-strapped regions, also have a place in modern labs Researchers took another leap forward in reducing the size of clinical laboratory diagnostic tests and observational tools. This demonstration involved lab-on-a-fiber technology and showed promise in both monitoring anatomic pathology biomarkers in vivo and supplementing the abilities of existing lab-on-a-chip and microfluidic...

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...