Hologic assay is first FDA-cleared test to detect M. genitalium February 2019—The Food and Drug Administration granted clearance for Hologic’s Aptima Mycoplasma genitalium assay. This is the first test the FDA has authorized for M. genitalium detection. The FDA reviewed data from a clinical study that included testing of 11,774 samples. The FDA says the study showed that the Aptima assay correctly identified M. genitalium in approximately 90 percent of vaginal, male urethral, male urine, and penile samples. It correctly identified M. genitalium in female urine and endocervical samples 77.8 percent of the time and 81.5 percent of the time, respectively. Vaginal swabs are the preferred sample type owing to better clinical performance. Alternative sample types, such as urine, can be used if vaginal swabs are not available. In addition, the study showed that the test correctly identified samples that did not have M. genitalium present 97.8 to 99.6 percent of the time. The FDA reviewed the Aptima M. genitalium assay through the de novo premarket pathway.Read More »
In Every Issue
Q. When performing a manual differential that contains immature cells, such as metamyelocytes and myelocytes, do you report an absolute count on all of the individual cells in the myelocytic line, or do you group them together and calculate one ANC? What about lymphocytes and reactive lymphocytes? Read answer. Q. Why and in what employment screening settings is the two-step skin test for Mycobacterium tuberculosis recommended? Read answer.Read More »
February 2019—In last month’s column, we talked about practice engagement as an umbrella term for laboratory medical direction and practice management that builds strong relationships within and beyond the laboratory. The CAP Practice Management Committee has been taking the lead on this, but it cuts across multiple domains; the conundrum, as always, is the complexity of what we do. Practice management tools designed for other settings cannot meet our needs because we must address economy, efficiency, effectiveness, and collegiality concerns specific to pathology. But then, affinity for complexity is how we landed here in the first place, so that plays to our strengths.Read More »
February 2019—Impact of commercial laboratory testing on a care delivery system: Care delivery systems have become increasingly fragmented and complex, which impacts patient care. The amount of health care data generated has also created a problem by reducing the time devoted to direct patient care.Read More »
February 2019—Diagnostic algorithmic proposal based on IHC evaluation of invasive endocervical adenocarcinomas: The International Endocervical Adenocarcinoma Criteria and Classification was developed to separate endocervical adenocarcinomas into two main categories based on morphology: human papilloma virus-associated (HPVA) and nonhuman papilloma virus-associated adenocarcinomas.Read More »
February 2019—Evaluation of mutational processes and somatic driver mutations in cancer exomes: As next-generation sequencing-based tumor profiling gains popularity, multiple informative variables other than single-gene alterations will continue to be added to clinical reports.Read More »
February 2019—Digital pathology RFPs: from the questions to selections: To those who request the information and those who supply the information, requests for proposal, better known as RFPs, can be groanworthy. Yet laboratories planning to purchase a digital pathology system for clinical use should seriously consider going through the painstaking process, even if their institutions don’t require it, says Liron Pantanowitz, MD, vice chair of pathology informatics at the University of Pittsburgh Medical Center.Read More »
FDA clears 2 of 3
ePlex blood culture ID panels:
January 2019—GenMark Diagnostics announced in December that it received FDA market clearance for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) and Fungal Pathogen (BCID-FP) panels. GenMark’s third panel, ePlex Blood Culture Identification Gram-Negative (BCID-GN), was submitted to the FDA in September 2018 and is still under review. The fungal pathogens panel has broad coverage and includes many resistant and emerging strains, among them Candida auris, GenMark said in its statement. The company says that by coupling BCID panels with the ePlex Templated Comments software module, hospitals can enable immediate intervention linked to a diagnostic result and improve the effectiveness of antimicrobial stewardship initiatives.
12 assays for Atellica Solution:
Siemens Healthineers achieved 12 pre-market approvals from the FDA for its Atellica Solution infectious disease and oncology testing menu.
January 2019—Virtual tumor board platforms: a game changer for cancer case review: If Suneal Jannapurredy, MD, had been able to read the patient’s outside radiology report prior to breast tumor board, he would have re-examined the gross specimen to determine whether, as the other providers were now telling him, there was a second area of focus he hadn’t included in his presentation.Read More »