FDA Authorizes First At-Home COVID-19 Antigen Tests, but Roadblocks Remain for “Fast-and-Frequent” Antigen Testing

Developers of medical laboratory tests had high hopes that cheap saliva-based tests would compete with at-home OTC tests that use nasal swabs, but skepticism among scientists continues Reverse-transcription polymerase chain reaction (RT-PCR) technology has become the standard for clinical laboratory diagnostic testing used to detect the presence of the SARS-CoV-2 coronavirus. However, to enable more widespread testing, some public health experts have called for deployment of cheap, rapid,...

Does Precision Oncology Offer Patients Superior Treatment Therapies? Anatomic Pathologists Will Be Interested to Learn Why Oncology Experts Disagree

Number of patients eligible for genome-driven oncology therapy is increasing, but the percentage who reportedly benefit from the therapy remains at less than 5% Advances in precision medicine in oncology (precision oncology) are fueling the need for clinical laboratory companion diagnostic tests that help physicians choose the best treatment protocols. In fact, this is a fast-growing area of clinical diagnostics for the nation’s anatomic pathologists. However, some experts in the field of...

Controversy Surrounding Memorial Sloan Kettering Cancer Center and Paige.AI Highlights Risks of Data Sharing and Monetization in Anatomic Pathology

Patient privacy, ethics of monetizing not-for-profit data, and questions surrounding industry conflicts appear after the public announcement of an arrangement to grant exclusive access to academic pathology slides and samples Clinical laboratories and anatomic pathology groups already serve as gatekeepers for a range of medical data used in patient treatments. Glass slides, paraffin-embedded tissue specimens, pathology reports, and autopsy records hold immense value to researchers. The...

IBM’s Watson Not Living Up to Hype, Wall Street Journal and Other Media Report; ‘Dr. Watson’ Has Yet to Show It Can Improve Patient Outcomes or Accurately Diagnose Cancer

Wall Street Journal reports IBM losing Watson-for-Oncology partners and clients, but scientists remain confident artificial intelligence will revolutionize diagnosis and treatment of disease What happens when a healthcare revolution is overhyped? Results fall short of expectations. That’s the diagnosis from the Wall Street Journal (WSJ) and other media outlets five years after IBM marketed its Watson supercomputer as having the potential to “revolutionize” cancer diagnosis and treatment. The...

Researchers’ Inability to Reproduce Results from Previous Cancer Studies Could Increase Pressure on Clinical Laboratories and Diagnostic Technology Developers

Pathologists in medical laboratories creating laboratory-developed tests (LDTs) should be aware that some in the scientific community want more transparency about technology and methods Developers of clinical laboratory tests and medical diagnostic technologies might soon be feeling the pressure to increase their push for transparency and standards that ultimately would make replication easier. That’s thanks to a review project’s inability to reproduce results from three of five high-profile...
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