June 2024

July 2, 2024—Cepheid has received FDA de novo marketing authorization and CLIA waiver approval for its Xpert HCV, the first point-of-care hepatitis C RNA test.

June 2024—When it comes to detecting cervical precancer (CIN3), p16/Ki-67 dual stain testing cuts down on the number of colposcopies compared with using Pap cytology to triage HPV-positive patients. “Using cytology [for triage], you need to do about 32 colposcopies to identify one cervical precancer [CIN3]. If you were to switch to dual stain, it cuts it in half,” says Thomas Lorey, MD, senior consultant and former director of laboratory services for Kaiser Permanente Northern California, from which much of the data underpinning the guidelines on cervical cancer screening and management have been collected. Dr. Lorey and others are coauthors of new clinical management dual stain test recommendations, released in March by the member organizations of the Enduring Consensus Cervical Cancer Screening and Management Guidelines effort. The new recommendations address only the Roche CINtec Plus Cytology test, which detects both p16 and Ki-67 and was approved by the Food and Drug Administration in 2020.

June 2024—Since ChatGPT sprang on the scene a year and a half ago, debate and concern about the OpenAI chatbot and how closely it can replicate human abilities have been widespread, as have thoughts on how to translate AI-based applications into clinical practice.

June 2024—At-home acute and advanced care testing, ethical quandaries, and the lab’s ecological footprint are three of the topics that ADLM meeting-goers can sign on for next month in Chicago.

June 2024—Meagan Chambers, MD, MS, MSc, feels like she has signed on for a life of being on call for 2 AM autopsies, and she says nothing could please her more. She is a neuropathology fellow at the University of Washington and does many of the rapid autopsies that make possible a range of human research that would otherwise be limited or out of reach.

June 2024—The Food and Drug Administration’s final rule on laboratory-developed tests was released April 29 and published May 6. Shortly after, Compass Group laboratory leaders met online with CAP TODAY publisher Bob McGonnagle, who asked for their early reactions to what they heard and read. Among the categories for which the FDA has indicated its intent to exercise partial enforcement discretion are LDTs manufactured and performed by a laboratory that is integrated within a health system and that meet an unmet medical need. Here, this month, is the conversation that took place in early May. Next month we will publish our story on the final rule and the views of others. The Compass Group is an organization of not-for-profit IDN system lab leaders who collaborate to identify and share best practices and strategies.

June 2024—Screening in transgender men with cervices and in transgender women with neovaginas was the focus of a CAP23 session that highlighted screening recommendations and morphologic challenges such as detecting high-grade dysplasia in a background of atrophy (trans men) and dysplasia risks (trans women)—and EHR-related improvements for both.

June 2024—In this case report, we aim to elucidate the importance of collaborative molecular and cytogenic testing to offer a diagnosis for complex prenatal situations, such as chimerism, defined by the presence of two genetically distinct cell lines derived from two or more zygotes.

June 2024—Idiopathic multicentric Castleman disease, which is driven by a cytokine storm with an unknown cause, is a difficult diagnosis and one that’s often delayed, owing to the disease’s rarity and nonspecific symptoms. “Patients often bounce around for months, or even years, to different specialties, based on how they present, before they are diagnosed,” said Jadee Neff, MD, PhD, assistant professor of pathology, Duke University Medical Center, in a CAP TODAY webinar in February made possible by a special educational grant from Recordati Rare Diseases.

June 2024—All of us in the pathology community, no matter how winding our career paths may have been, at some point made the same choice. Of all the medical specialties available to us, we were drawn to become pathologists.

June 2024—In today’s health care environment, clinical laboratories increasingly must focus on test optimization, or generating quality patient care in a timely manner while controlling costs. A metric that can assist with test optimization is turnaround time (TAT), the reduction of which can lead to earlier diagnosis and treatment. Conducting assays in house is one way to potentially reduce TAT. Laboratories often use test volume and the cost of reagents, equipment, and personnel to determine the benefit of bringing an assay in house. However, it is important not to overlook the impact and costs that extend beyond the laboratory with regard to patient care and potential savings from improved care.

June 2024—Neuroendocrine neoplasms can arise in a variety of anatomic sites, including the gastrointestinal tract, pancreas, and lung. The authors conducted a study in which they examined the diagnostic utility of S100 protein expression by IHC. They reported on the expression of S100 protein in a tissue microarray composed of 919 primary and metastatic neuroendocrine neoplasms from 548 patients. S100 protein is commonly used by laboratories to identify neural and melanocytic neoplasms. It is occasionally used in the workup of neuroendocrine neoplasms when the diagnosis of paraganglioma is being considered.

June 2024—Somatic mutations in SETBP1 occur in a variety of myeloid malignancies, including myelodysplastic/myeloproliferative neoplasms, typically as secondary events during oncogenesis. However, whether SETBP1 alterations can serve as an initiating event for myeloid neoplasia and what other factors may influence the phenotype of SETBP1-mutated myeloid neoplasms remains unclear. To determine if SETBP1 mutations can initiate leukemia in vivo, the authors generated a mouse model expressing mutated SETBP1 in hematopoietic tissue. They reported that SETBP1^G870S-mutated mice developed a chronic myeloid disorder with massive hepatosplenomegaly, myelofibrosis, atypical megakaryocytes, and granulocytic hyperplasia without granulocytic or erythroid dysplasia. SETBP1^G870S precursors showed significant alterations in the transcriptional programs of differentiating hematopoietic cells, promoting granulocytic/monocytic differentiation while suppressing erythroid differentiation.

June 2024 Q. What are the requirements for correcting an automated white blood cell (WBC) count for the presence of megakaryocytes? Is there a formula for correcting it for megakaryocytes, as there is for the presence of nucleated red blood cells (nRBCs)? Read answer. Q. Are there guidelines on how often a patient should be monitored for a blood transfusion reaction? Should reactions be monitored as frequently as vital signs? Read answer.

June 2024—Fairness, like so many principles, is subjective. Yet that is not deterring a growing number of medical informaticists and others interested in health care technology from advocating to incorporate fairness into machine learning algorithms to combat bias.

June 2024—The Food and Drug Administration in May approved the two HPV self-collection approaches from Roche and BD.