January 2024

January 2024—Sometimes even superb ideas can also turn out to be quite, well, bothersome. Zoom meetings. Bridal showers. Bike lanes. Parking apps. QR menu codes. And—if laboratories aren’t careful—the same can be true of pharmacogenomic testing. Just ask Ann Moyer, MD, PhD, associate professor, laboratory medicine and pathology, Mayo Clinic. When it comes to pharmacogenomic testing, laboratory medicine brings significant expertise to the table. But in clinical settings, physicians who prescribe the medications need to be familiar with how to use the test results. They also need to work with the lab to decide which tests, for which genes or gene-drug pairs, will be most helpful for their patients, she says. “Especially if you’re going to start incorporating clinical support alerts into the EHR,” adds Dr. Moyer, who was chair of (until Dec. 31; she is now advisor to) the CAP/ACMG Biochemical and Molecular Genetics Committee. “If the practice doesn’t actually want them, then you’re just going to end up annoying them.”

January 2024—Thrombophilia testing has been shown to be performed far more often than indicated in thromboembolic events, at significant cost to the patient and hospital.

January 2024—The Food and Drug Administration’s proposed rule on laboratory-developed tests would phase out its existing enforcement discretion approach for oversight of LDTs. Instead, the FDA would classify in vitro diagnostics offered as LDTs as class I, II, or III medical devices depending on their risk to patients.

January 2024—Much has been said and written about scoring HER2-low breast cancer, and it has its difficulties. But there are steps and tools to support scoring, and Savitri Krishnamurthy, MD, last fall shined a light on them and several HER2-low breast cancer-related studies.

January 2024—Seven recommendations for the use of cardiac troponin measurement at the point of care were published last year and reported in a session at the Association for Diagnostics and Laboratory Medicine annual meeting, shortly after the recommendations appeared in print.

January 2024—Thoracic SMARCA4-deficient undifferentiated tumor (TSDUT), formerly known as SMARCA4-deficient thoracic sarcoma and SMARCA4-deficient thoracic sarcomatoid tumor, is a relatively newly defined entity with a distinct clinical history, morphology, immunohistochemical profile, molecular findings, and clinical behavior.

January 2024—The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC) is a widely endorsed and globally adapted standardized reporting system of thyroid fine-needle aspiration specimens.

January 2024—Urinary cytology is widely used to screen for high-grade urothelial carcinoma (HGUC) and to monitor for recurrence. Several reporting systems have been proposed over the past few decades, but The Paris System (TPS) for Reporting Urinary Cytology is the most widely applied worldwide.

January 2024—Viscoelastic assays and other coagulation tests were front and center when CAP TODAY publisher Bob McGonnagle on Nov. 20 convened seven people in an online roundtable. Oksana Volod, MD, and Eric Salazar, MD, PhD, and five company representatives weighed in on, among other things, appropriate test use, automation, and laboratory-developed tests. What they said begins here.

January 2024—I was planning to write about a much more pleasant topic this month, but instead I’ll use this column to address something that’s gnawing at all of us now: the prospect of FDA regulation of laboratory-developed tests.

January 2024—People respond differently to SARS-CoV-2 infection, with some having a very severe clinical course and sequelae while others recover quickly. Several research studies have used laboratory data to identify patient populations most at risk for severe outcome from COVID-19. However, many of these studies were conducted in China and did not represent the demographics of the U.S. population. Among the drawbacks of these studies were that most analyzed variance between two patient groups, yet statistical differences don’t always correlate with clinically useful predictions. Furthermore, these studies used data from throughout patients’ disease course, and clinicians would like to identify patients at risk during their initial interaction.

January 2024—Diffuse parenchymal lung disease is a well-recognized complication of systemic connective tissue disease but rarely arises in patients with psoriasis or psoriatic arthritis, which are poorly understood. Therefore, the authors conducted a study to characterize diffuse parenchymal lung disease (DPLD) associated with psoriasis or psoriatic arthritis, with or without prior immunomodulation. Their pathology consultation files were searched for patients having psoriasis or psoriatic arthritis and DPLD. After excluding cases with active infection or smoking-related DPLD only, 44 patients (22 of whom were women; median age, 60 years; range, 23–81 years) were enrolled in the study. Clinical history and pathology slides were reviewed.

January 2024—DDX41 is involved in multiple cellular processes, including RNA metabolism and splicing. Inherited variants have been linked to an increased risk of the blood neoplasms myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

January 2024 Q. Can a person who has a bachelor of science degree in health care administration sign off on competency assessments? Read answer. Q. Our laboratory uses a total protein assay from Beckman Coulter that has an analytical measurement range of 3–12 g/dL for serum determinations. The assay sensitivity states 1 g/dL of total protein. Can we loop sensitivity into our AMR and make our reporting range 1–12 g/dL? Will this make our assay a laboratory-developed test? Quite often our clinicians need assays reported to 1 g/dL, since they need to calculate the ratio of total protein serum to body fluid as per Light’s criteria. If we report to 1 g/dL, we have to loop sensitivity into our AMR. Read answer.

January 2024—When the medical microbiology laboratory at Yale-New Haven Hospital makes operational changes, it uses data analytics to monitor their impact. Yet the process of implementing laboratory analytics can be challenging.

January 2024—The Association for Molecular Pathology on Dec. 14 published a joint report on what to consider for a slice testing strategy for diagnostics, including gene selection, analytic performance, coverage, quality, and interpretation. Slice testing is the practice of bioinformatically selecting a subset of genes from exome or genome sequencing assays.