Cedars-Sinai Researchers Determine Smartphone App Can Assess Stool Form as Well as Gastroenterologists and Better than IBS Patients

Mar 8, 2023 | Clinical Laboratory Middleware, Informatics, Analytics, Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Testing, Precision Medicine

Artificial intelligence performs BSS assessments with higher sensitivity and specificity than human diagnosticians In a recent study conducted by scientists at Cedars-Sinai Medical Center in Los Angeles, researchers evaluated a smartphone application (app) that uses artificial intelligence (AI) to assess and characterize digital images of stool samples. The app, it turns out, matched the accuracy of participating gastroenterologists and exceeded the accuracy of study patients’ self-reports of...

Does Giving a Patient a $75 Gift Card to Send in a Clinical Laboratory Test Specimen Violate Federal Fraud Laws? A Whistleblower Lawsuit Argues ‘Yes!’

Mar 6, 2023 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Testing, Molecular Diagnostics, Genetic Testing, Whole Gene Sequencing

Novel scheme by medical laboratory company to induce patients to collect and return their own specimen for testing is central to a federal whistleblower case alleging violations of the Anti-Kickback Statute Handing out gift cards only to patients who return a specimen to a clinical laboratory company for colorectal cancer screening is a unique approach that is now at the center of a federal qui tamcase filed by a retired Indiana pathologist. The defendant in this whistleblower lawsuit is Exact...

International Team of Scientists Develop Smart Diaper That Alerts Parents When It Is Soiled and Needs to Be Changed

Mar 3, 2023 | International Laboratory News, Laboratory Instruments & Laboratory Equipment, Laboratory Pathology, Laboratory Resources, Laboratory Testing

Not the first smart diaper to come along, but consumers seem unready for diapers that can flag urinary tract infections and other biomarkers usually tested by clinical laboratories Will wonders never cease? For centuries, parents had only their own senses to determine when infants needed diaper changing. Today, however, caregivers can rely on “smart diapers” to send alerts when a diaper is soiled. Crying, smelly babies may no longer be the gold standard in diaper management. But are smart...

University of Washington Researchers Use Genomic Analysis to Track Shigella Infections as Decreased Cost of Gene Sequencing Aids Public Health Research

Mar 1, 2023 | International Laboratory News, Laboratory Pathology, Laboratory Testing, Molecular Diagnostics, Genetic Testing, Whole Gene Sequencing

Another study in the United Kingdom that also used genomic analysis to understand drug-resistant Shigella produced findings that may be useful for microbiologists and medical laboratory scientists From the onset of an infectious disease outbreak, public health officials, microbiologists, and clinical laboratory managers find it valuable to trace the origin of the spread back to the “index case” or “patient zero”—the first documented patient in the disease epidemic. Given the decreased cost of...

Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Feb 27, 2023 | Compliance, Legal, and Malpractice, Laboratory Pathology, Laboratory Resources, Laboratory Sales and Marketing, Laboratory Testing

Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate...