Emily Hayes[email protected]Ovarian CancerMolecular genotyping shines light on serous ovarian cancerHigh-grade serous ovarian cancer is the most malignant form of ovarian cancer, causing up to 70% of ovarian cancer deaths. The new study validated a new classifier tool called the predictor of high-grade serous ovarian carcinoma (HGSOC) molecular subtype (ProType), which encompasses 55 genes plus five housekeeping genes and is based on the NanoString platform.June 17, 2020CarcinomaGoogle reports pathology AI helps predict survival in cancer patientsThe deep-learning system was developed and tested using histopathology slides for patients with 10 cancer types -- including bladder cancer, invasive breast cancer, and head and neck squamous cell carcinoma -- drawing from publicly available data from the Cancer Genome Atlas (TCGA) program.June 17, 2020FDA ClearanceFDA finds false results with Chembio coronavirus antibody test, revokes clearanceThe agency announced the removal of the immunoglobulin M (IgM) and immunoglobulin G (IgG) test on June 16. In a statement, the agency noted that the test was one of the first to get an authorization and that initially the product met its standards during the COVID-19 public health emergency when it had appeared that benefits outweighed harms.June 16, 2020Bacterial InfectionsProcalcitonin test signals infection in heart attack patientsAs an important marker for inflammation in the body, a blood test for PCT is useful for systemic bacterial infections and sepsis. But its value for detecting infection in patients with acute ST-elevation myocardial infarction (STEMI) -- an area of unmet need -- has been unclear. One key question is whether it is specific enough for infection, or whether levels would increase due to cardiac injury -- a limitation of other inflammatory biomarkers such as C-reactive protein (CRP) and white blood cell counts.June 15, 2020Cancer of Unknown PrimaryWeek in Review: Coronavirus stool samples under scrutiny | Testing company accused of fraud | Genetic risk scoring in heart diseaseDear LabPulse Member,June 11, 2020Gastrointestinal DiseaseMore stool PCR testing likely needed in COVID-19 patientsCOVID-19 is commonly seen as a respiratory disease and much of the focus for diagnosis and also discharge of patients from hospitals following recovery has understandably been on the status of respiratory specimens. But gastrointestinal symptoms are also part of the disease and deserve more attention to help "prevent further spread of this highly contagious pathogen," wrote Dr. Sravanthi Parasa, a gastroenterologist at Swedish Medical Center in Seattle, and colleagues.June 11, 2020Heart DiseaseWho stands to gain from polygenic risk scoring for heart disease?The retrospective study evaluated the value of polygenic risk scores (PRSs) in a total of 47,108 middle-aged people (mean, 60 years) treated at hospitals affiliated with three different U.S. institutions on the East Coast: Partners HealthCare (MA), the University of Pennsylvania Health System (PA), and the Mount Sinai Health System (NY).June 9, 2020InfectiousNew coronavirus lab test reporting rules address complaints on spotty dataGrilled on the spotty nature of COVID-19 testing during a House Appropriations Committee hearing on June 4, Redfield acknowledged shortcomings of public health data collection throughout the nation, with some states still using pen and pencil.June 7, 2020Point-of-Care TestingWeek in Review: More COVID-19 help for smaller practices | Tackling test supply shortages | Case for AML genetic profilingDear LabPulse Member,June 4, 2020LeukemiaTaking time out for genetic testing in acute myeloid leukemia may be OKThe retrospective real-world study evaluated outcomes for AML patients included in the Study Alliance Leukemia (SAL) AML registry, which includes 46 treatment centers in Germany. Researchers set out to evaluate how differences in the length of time from diagnosis to start of treatment correlated with overall survival and other key outcomes in patients newly diagnosed with and previously untreated for AML.June 4, 2020Previous PagePage 4 of 27Next PageTop StoriesPolicy and RegulationFDA releases LDT final ruleThe FDA announced its final rule on regulating laboratory developed tests (LDTs), also saying it will adopt targeted enforcement discretion for several categories of IVD LDTs manufactured by labs.COVID-19Study: Age-related differences in nasal cells offer COVID-19 protectionFDA ClearancePillar Biosciences gets FDA approval for NGS solid tumor profiling testValidationImmunovia announces positive results for next-gen pancreatic cancer testSponsor ContentVisit our Molecular Diagnostics Community