Targeted Cancer Therapies Bring New Precision Medicine Tools to Anatomic Pathologists and Clinical Laboratories

FDA is streamlining how new diagnostic tests are approved; encourages IVD companies to focus on ‘qualifying biomarkers’ in development of new cancer drugs It is good news for the anatomic pathology profession that new insights into the human immune system are triggering not only a wave of new therapeutic drugs, but also the need for companion diagnostic tests that help physicians decide when it is appropriate to prescribe immunotherapy drugs. Rapid advances in precision medicine, and the...

University of Texas Researchers Develop New Techniques in Genetic Testing to Improve Clinical Laboratory Results through RNA

Innovative technological advances could potentially provide clinical laboratories, pathology groups, and medical researchers with improved methodologies for designing, performing, and analyzing lab tests that use genetic information Researchers at the University of Texas at Austin (UT Austin) have developed an innovative new enzyme that promises to improve the methods and tools used by pathology groups and clinical laboratories when conducting genetic testing. The enzyme enables the...

Pathologists and Physicians in United Kingdom Comment on How Shortage of Medical Laboratory Professionals Could Soon Delay Essential Diagnostic, Therapeutic Testing

As chronic disease and aging populations strain the UK’s medical systems, staffing shortages at pathology laboratories contribute to lengthening delays of critical diagnostic services In the United Kingdom (UK), pathologists and other physicians are going public with their concerns that a growing shortage of pathologists and medical laboratory scientists will soon contribute to delays in performing the lab tests needed to diagnose patients—particularly those with cancer—and identify which...

Molecular Information Management Systems (MIMS) Are Newest Tools to Help Clinical Laboratories Perform and Report Molecular and Genetic Test Results

Some experts consider MIMS to be the classic LIS on steroids because they are designed to handle the vast amounts of data generated by the latest generation of genetic tests Steady improvements to next-generation genetic sequencing, lab-on-a-chip technologies, and lab automation are triggering substantial increases in the volume of data generated at medical laboratories and pathology groups. The future of personalized medicine lies just as much in the analysis of the data generated by these...

Precision Healthcare Milestone Reached as Food and Drug Administration Clears New Multi-Marker Medical Laboratory Test to Detect Antibiotic-Resistant Bacteria

FDA issues press release following clearance of a clinical lab test to detect genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae Clearance by the US Food and Drug Administration (FDA) of a new rapid, multi-marker genetic test designed to identify bacteria that are resistant to Carbapenem antibiotics was considered significant enough that the federal agency issued a press release announcing that the test was cleared and now available for use by physicians and...