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Castle Biosciences DecisionDx DiffDx-Melanoma

Castle Biosciences has launched DecisionDx DiffDx-Melanoma, a gene expression profile test for use in patients with suspicious pigmented lesions. The test is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions, and classifies these lesions as either benign (gene expression profile suggestive of benign neoplasm), intermediate-risk (gene expression profile cannot exclude malignancy), or malignant (gene expression profile suggestive of melanoma).

The intent-to-treat analysis of the DiffDx-Melanoma validation study showed that the test accurately diagnosed malignant and benign cases at a rate of 96.6 percent, with 99.1 percent sensitivity, 94.3 percent specificity, 93.6 percent positive predictive value, and 99.2 percent negative predictive value, the company said. An intermediate-risk result was identified in 3.6 percent of the cases.

The Scan

Another Resignation

According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug.

Novavax Finds Its Vaccine Effective

Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19.

Can't Be Used

The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports.

PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More

In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.