April 2023

April 2023—After years of excitement and scientific breakthroughs, the use of molecular testing to guide cancer therapeutics finally is coming into its own. Unfortunately, it appears to have landed in the wrong place at the right time. That place is a lonely spot, surrounded by gaps in economics and coverage, as well as knowledge, guidelines, ordering patterns, turnaround times, reporting, and the like. So plentiful are the gaps that, put together, they could form a vast, inhospitable space, a veritable Colorado Plateau, with molecular testing as a majestic, enticing but remote rocky pinnacle in the middle. Think Monument Valley. It’s worth the trek. The evidence in support of genomic profiling continues to grow. Simply put, “Patients with the right markers who get the right drugs do better,” says Neal Lindeman, MD, vice chair, laboratory medicine and molecular pathology, Department of Pathology and Laboratory Medicine, Weill Cornell Medicine/New York Presbyterian Hospital. But as numerous studies are showing, the lag in testing is growing as well.

April 2023—Celiac disease incidence is up and the diagnostic rate is low, and it can be years from onset of symptoms to diagnosis. “It’s a long diagnostic odyssey, and so in the laboratory business, we’re all in to help,” says Annette Taylor, MS, PhD, associate vice president at Labcorp where she is strategic director of pharmacogenomics and scientific director of molecular genetics.

April 2023—Traumatic brain injury triage in the emergency department is badly in need of biomarkers—and ones that can change practice. “If biomarkers don’t change practice, they’re a waste of time,” said W. Frank Peacock IV, MD, professor of emergency medicine, vice chair of research, and research director, Department of Emergency Medicine, Baylor College of Medicine.

April 2023—Pradip Datta, PhD, D(ABCC), senior staff technical team leader, Siemens Healthineers, Newark, Del., highlighted the list of traumatic brain injury biomarkers—what they are, what’s available, what’s promising.

April 2023—How is the demand for biomarker tests linked to new oncology drugs playing out in your health system? It is one of several questions laboratory leaders answered in a March 7 Compass Group call led by Stan Schofield, VP and managing principal of the Compass Group and formerly of NorDx/MaineHealth. That and digital pathology and the cost of storage, staffing and wages, the release of results, and the financial implications of the end of the public health emergency were the topics of the day. The Compass Group is an organization of not-for-profit IDN system laboratory leaders who collaborate to identify and share best practices and strategies.

April 2023—With serous ovarian carcinomas and other gynecologic tumors, it’s molecular testing that increasingly sets the treatment course. “As pathologists, it’s exciting to us,” said Sadia Sayeed, MD, speaking at CAP22. “We’re learning that the immunostains we’re interpreting have greater implications than we ever thought they could.”

April 2023—Molecular testing guidelines say that the neoplastic cell content of each specimen should be assessed, but there are no formal recommendations or guidelines on how to do the assessment.

April 2023—Another administrative layer and “up in the air” is how lab billing experts describe what the No Surprises Act requires of laboratories and where things stand. When they met online March 3 with CAP TODAY publisher Bob McGonnagle, they talked about this and digital pathology and the problems of no or slow payments. “Compared with five years ago, the number of denials has increased and turnaround time on full payment on a claim has lengthened significantly,” said Tom Scheanwald of APS Medical Billing.

April 2023—Here is a scenario for you: Your hospital administration team identifies a strategic need and establishes a new service line, perhaps in cardiology or women’s health. They speak with the relevant surgeons and specialists, gathering expert perspectives about this new service line. But only after everything else has been put in place does anyone consider how laboratory medicine will play a role. Sound familiar?  

April 2023—Cancer is the second leading cause of death globally. While great progress is being made in personalized cancer treatments, early detection and diagnosis is critical to reduce mortality and improve the effectiveness of treatment. Guidelines for preventative screening are available but require a large public health intervention strategy. Having “one-stop-shop” screening for multiple cancers at one time would reduce the barriers to participating in cancer screening programs and may lead to greater numbers of screening participants. An integrated cancer prevention center (ICPC) was developed in 2006 at the Tel Aviv Medical Center, in Israel, to screen for all cancers that the U.S. Preventive Services Task Force recommends be screened, including breast, colon, cervical, lung, skin, ovarian, uterine, thyroid, testicular, oropharyngeal, and prostate cancer.  

April 2023—Kaposi sarcoma can pose diagnostic challenges in biopsy specimens. Multiple histologic variants of cutaneous Kaposi sarcoma (KS) have been described. However, the histomorphologic spectrum of gastrointestinal KS has not been systematically studied. The authors presented a large multi-institutional case series that comprehensively evaluated 46 cases of KS involving the GI tract and identified seven histomorphologic variants, some of which had not previously been described. Five of the variants—lymphangioma/lymphangiectatic like (n=17), mucosal hemorrhage/telangiectatic like (n=17), mucosal inflammation like (n=15), granulation tissue like (n=13), and mucosal prolapse like (n=4)—were inconspicuous but had unique morphologic patterns. These variants easily can be misdiagnosed or misinterpreted on routine examination if KS is not considered and if the IHC stain for human herpesvirus-8 is not utilized.  

April 2023—Clonal hematopoiesis of indeterminate potential refers to the clonal expansion of hematopoietic stem cells that harbor a somatic mutation in people who do not exhibit hematological symptoms. This phenomenon is common in the elderly and associated with an increased risk of hematological malignancies, cardiovascular disease, infection, and all-cause mortality. Several somatic alterations are frequently detected in clonal hematopoiesis of indeterminate potential (CHIP), but the medical community’s understanding of the underlying genetic predisposition to CHIP is limited. The authors conducted a large-scale exome-sequencing study involving more than 600,000 people to characterize CHIP status and discover rare somatic variants and possible predisposing germline alterations. The prevalence of CHIP was 15 percent by 75 years of age, and the affected individuals were more likely to be heavy smokers, in agreement with previous studies.  

April 2023 Q. Which criteria should be used to interpret mixing studies, not only for lupus anticoagulants but also for other inhibitors? Read answer. Q. How does the CAP checklist requirement COM.30840 Pipette Carryover relate to blood bank automation? Are there CAP guidelines that address pipette carryover relative to such systems? Read answer. Q. Our laboratory is assessing criteria for determining quantity not sufficient for a microscopic urinalysis. We were using an automated instrument but have gone back to manual microscopy for reasons beyond our control. While most textbooks state that 10 to 15 mL is the desired amount of sample for testing, it appears that many laboratories require smaller amounts. Can you provide guidance? Read answer.

April 2023—At the medical center of the University of Medicine and Pharmacy at Ho Chi Minh City, patients are not screened for bladder cancer using urine cytology because the pathology department does not have the capability for such screening. But that may soon change, thanks to an organization focused on using digital pathology to increase the availability of pathology education resources in developing countries.

April 2023—Abbott has received FDA clearance for its Alinity i TBI laboratory test for traumatic brain injury. The test provides a result in 18 minutes to help clinicians assess concussion and triage patients.

April 2023—There have been several recent articles in CAP TODAY regarding the use of whole blood and prehospital transfusion. The general tenor of the reporting has supported these novel practices. We would like to suggest an alternative perspective.