NEWS
Guideline on biomarker testing of multiple cancers
A new College of American Pathologists (CAP) evidence-based guideline is among the first to address testing based less on the cancer type or tumour origin and more on the methodology and status of a biomarker. The Mismatch Repair (MMR) and
Microsatellite Instability (MSI) Testing for Immune Checkpoint Inhibitor Therapy guideline provides clarity for pathologists and oncologists to improve the evaluation of patients with colorectal (pictured), endometrial, gastroesophageal, small bowel, and certain other cancers who may be eligible for immunotherapies known as immune checkpoint inhibitors. Published online in the journal Archives of Pathology & Laboratory Medicine, the guideline also breaks new ground with recommendations on the role of tumour mutational burden in MMR testing and the evaluation for Lynch syndrome, a hereditary cancer syndrome that may be unexpectedly detected in the work-up of these patients with advanced cancers. CAP developed the guideline in collaboration with experts from the Association for Molecular Pathology (AMP), the American Society of Clinical Oncology (ASCO), and the patient
advocacy group Fight Colorectal Cancer (Fight CRC). With six recommendations and three good practice statements, the guideline provides data and details regarding the efficacy and utility of specific testing modalities across applicable cancer types, including MMR by immunohistochemistry, MSI by polymerase chain reaction, and MSI by next-generation sequencing. In addition, the guideline identifies gaps in our current knowledge base, which, when addressed, may represent opportunities to help improve the methodological approach for identifying the patients with advanced cancers who are most likely to respond to this therapeutic approach.
www.cap.org
Testing for amyloid diagnosis
Data from C2N Diagnostics shows that a blood test combining the Aβ42/40 ratio, a component of C2N’s PrecivityAD blood test, offers accuracy comparable to amyloid PET imaging and invasive CSF tests in identifying Alzheimer’s brain pathology. The study, based on a difficult-to- diagnose population of 221 individuals dealing with cognitive impairment of unclear aetiology who were originally part of the IDEAS study, observed that adding C2N’s proprietary p-tau217 ratio measurement to its existing Aβ42/40 ratio measurement greatly facilitates the identification of patients with Alzheimer’s brain pathology, even at the earliest stages of disease accumulation. The integrated score derived from the p-tau217 ratio and Aβ42/40 ratio achieved an AUC performance of 0.96 and accuracy of 90% when compared with quantitative amyloid PET results.
C2N introduced the clinically validated
PrecivityAD blood test over a year ago to help healthcare providers determine the presence or absence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease.
The new C2N assay relies on high-
resolution mass spectrometry to precisely measure from a single sample of blood multiple different proteins implicated in Alzheimer’s-related brain changes. These markers include the beta-amyloid 42 and 40 peptides, and different phosphorylated and non-phosphorylated forms of the tau protein, including forms with phosphorylation at the tau217 and tau181 sites. Combining the Aβ42/40 ratio with the p-tau217/non- ptau217 ratio into a single integrated score resulted in superior performance to identify the presence or absence of brain amyloid plaques.
https://c2n.com/
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