September 2020

April 2021—A 71-year-old female with a history of asthma and hypertension initially presented to her local hospital complaining of shortness of breath. She was found to be pancytopenic with severe anemia (hemoglobin 5 g/dL). She was subsequently transferred to a tertiary care facility for further evaluation. Bone marrow biopsy revealed a hypercellular marrow composed of 72 percent blasts. Flow cytometric analysis revealed a B-lymphoblast immunophenotype with expression of CD34, dim CD45, CD19, CD79a, CD22, HLA-DR, TDT, CD200, CD33, and dim CD13.

September 2020—Between a rock and a hard place. Trying to stay ahead, trying to build inventory. Chasing multiple new testing requests. Anticipating influenza. That’s where laboratory leaders said their labs were in early August when CAP TODAY publisher Bob McGonnagle convened members of the Compass Group on Zoom to share their pandemic experiences. They shared surprise, too, that the situation is what it is: “Not a clue in my mind that this would go past the springtime,” said Stan Schofield, president of NorDx and senior VP, MaineHealth. McGonnagle asked them about the diversion of supplies, the coming flu season, IT support, lessons and long-term changes, and more.

See current issue below for additional COVID-19 coverage or access all COVID-19 articles here.

September 2020—Bill Gates was just 10 years old and the Beatles were still playing live concerts when the concept of patient-based real-time quality control was proposed in 1965. At the time, patient-based real-time QC (PBRTQC) was based on the “average of normals,” a precursor of moving averages.

September 2020—The twinned challenge of testing for SARS-CoV-2 and the upcoming influenza season has a bit of The Cat in the Hat energy running through it. How does one manage to keep Thing One and Thing Two from creating unmitigated chaos? Maybe one doesn’t, not completely. A pandemic-based flu season will by its very nature be protean.

September 2020—Strong quality management, patient safety, and conformity with regulations are at the heart of the new and revised requirements in the 2020 CAP accreditation program transfusion medicine checklist, released in June.

September 2020—Great mentors, once passed, live on in the ideas, memories, and dreams of their students. For those like me, lucky enough to have been a student of Juan Rosai, MD, and to have heard him speak, the experience will never be forgotten.

September 2020—Genetic testing in ovarian cancer has a therapeutic implication that will aid in developing a treatment plan, and it is pathologists who should take the lead in creating the testing protocol, said Samuel Caughron, MD, pathologist, president, and CEO of MAWD Pathology Group, in a recent CAP TODAY webinar. Dr. Caughron explained the rationale for universal homologous recombination deficiency testing in patients with advanced ovarian cancer. The webinar, made possible by a medical sponsorship from AstraZeneca, is at <a href="https://www.captodayonline.com">www.captodayonline.com</a>.

September 2020—Professionalism in Pathology and Laboratory Medicine is a new book now out from CAP Publications. It provides a basic understanding, educational and assessment tools, 105 cases specific to pathology and laboratory medicine, guidance in recognizing and addressing lapses in behavior, discussions on best practices and legal and ethical aspects, and much more. Ronald E. Domen, MD, of Penn State College of Medicine and Hershey Medical Center, is editor. His co-editors are Richard M. Conran, MD, PhD, JD, of Eastern Virginia Medical School; Robert D. Hoffman, MD, PhD, of Vanderbilt University School of Medicine; Cindy B. McCloskey, MD, of the University of Oklahoma Health Sciences Center; and Suzanne Zein-Eldin Powell, MD, of Houston Methodist Hospital.

September 2020—Acute myeloid leukemia was one of the first diseases for which T cells were incorporated into the therapeutic paradigm, in the form of allogeneic stem cell transplant and donor lymphocyte infusion. Why then are there no approved immune therapies, or more specifically checkpoint inhibitors, for this T-cell–sensitive disease?

September 2020—A 64-year-old male presented with worsening shortness of breath, dry cough, and bilateral leg edema. He had a history of diabetes mellitus type two, hypertension, seropositive rheumatoid arthritis, and tobacco and alcohol abuse. CT scan demonstrated bilateral pleural effusions, pulmonary edema, subsegmental atelectasis, mildly enlarged hilar lymph nodes, mild cardiomegaly with a small pericardial effusion, and liver cirrhosis with a liver nodule. A hepatitis panel demonstrated positive serology for hepatitis C virus infection.

September 2020—Pathologists have been feeling the pain for months. The COVID-19 pandemic triggered furloughs and layoffs even as we ran a grueling race to implement and scale high-quality testing. And now looming cuts to pathologist physician payments threaten to make our situation even worse.

September 2020—The clinical features and immune responses of people infected with SARS-CoV-2 who are asymptomatic are under investigation since people without disease symptoms can unknowingly spread the virus. As of Aug. 3, there were 17,965,128 confirmed COVID-19 cases worldwide, 4,749,138 of which were in the United States. The majority of those with SARS-CoV-2 infection have mild to severe respiratory illness with fever, cough, and shortness of breath, which appears two to 14 days after exposure. The authors conducted a study in which they described the epidemiological and clinical characteristics, viral levels, and immune responses in 37 asymptomatic people to better understand the clinical features and immune responses of people who are infected with SARS-CoV-2 and asymptomatic. The 37 asymptomatic people, all in the Wanzhou district of China, were diagnosed with RT-PCR–confirmed SARS-CoV-2 infections but had no relevant clinical symptoms in the preceding 14 days or while quarantined at the government-designated hospital for centralized isolation in Wanzhou.

September 2020—Identifying patients who respond to immune checkpoint blockade is a significant challenge in oncology. PD-L1 expression by immunohistochemistry is the diagnostic gold standard for patient selection, but it does not capture all patients who may respond to immune checkpoint blockade (ICB). Recent gene-expression studies of high-grade serous ovarian carcinoma have defined an immunoreactive molecular subtype that shows a measurable favorable difference in patient survival compared with nonimmunoreactive subtypes, but no studies have demonstrated its impact on predicting response to ICB. As a step toward establishing the predictive value of gene-expression classifiers in ICB, the authors assessed the relationship between PD-L1 IHC and molecular subtypes of ovarian epithelial cancer. They analyzed 93 tissue specimens from patients with stages III and IV disease and compared PD-L1 IHC with gene expression by Agilent microarrays using The Cancer Genome Atlas-defined subtypes.

September 2020—Whole genome methylation profiling is used to subclassify neuroepithelial tumors and soft tissue sarcomas. Extending its use to much more common cancers, such as prostate cancer, has the potential to benefit a large number of patients. Metastatic castration-resistant prostate cancer (mCRPC) is the incurable and lethal form of prostate cancer and consists of different subgroups with variable morphologies and genomic alterations. The emergence of distinct subtypes of mCRPC likely represents adaption of the cancer cells to treatment and the microenvironment. The authors conducted a study that integrated methylation profiling with genomic sequencing and RNA transcriptome analysis in 100 mCRPC tumors, yielding a comprehensive molecular profile of these metastatic tumors.

September 2020—Whole slide imaging has been available for clinical, research, and educational use for decades, with several digital pathology systems cleared by the FDA for primary diagnosis. However, widespread adoption of this technology for routine practice has been slow. Likely reasons for the slow uptick in employing whole slide imaging (WSI) for sign-out include the cost of these systems, their lack of interoperability with laboratory information systems, pathologist resistance to using this digital modality, and regulatory restrictions on remote sign-out imposed by the Clinical Laboratory Improvement Amendments (CLIA). However, the COVID-19 pandemic led the Trump administration, on March 26, to temporarily waive these CLIA regulations, giving pathologists the flexibility to sign out cases digitally from their homes.

Q. Is the evaluation of gene copies by RT-PCR or multiplex ligation-dependent probe amplification a qualitative or quantitative assay? Copy number analysis of genes or chromosomes determines a numerical value, with a normal autosomal count being two. However, an FDA-approved microarray test (CytoScan Dx assay, Thermo Fisher Scientific) is labeled as a qualitative assay for the detection of copy number variations. Read answer. Q. How does using sodium heparin, in an attempt to reduce EDTA-induced platelet clumps, affect the platelet count? Read answer. Q. How do you know whether thyroid-stimulating hormone isoforms have been measured in an assay when the TSH levels are very high and free T4 is considerably less than the reference interval (i.e. less than 50 percent of the reference interval)? Read answer.

September 2020—While the SARS-CoV-2 outbreak has led many long-standing companies to zig instead of zag, it caused the computational and digital pathology startup Crosscope to switch gears in the midst of developing its first product.

Roche launches Preanalytical System, announces FDA OK for HER2 Dual ISH test as CDx
September 2020—Roche launched its Cobas Prime Preanalytical System to improve efficiency in molecular diagnostics laboratories. It is now commercially available in the United States and markets accepting the CE mark. The system is designed to automate all preanalytic steps and features cross-contamination control of samples. It has track-connectable modular configurations with one workflow for multiple sample types, end-to-end automation with predictable lab turnaround time, and IT integration with sample and test tracking.