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In Brief This Week: DermTech, Centogene, Devyser

NEW YORK – Genomic skin diagnostics firm DermTech said this week that it is discontinuing the optional TERT promoter mutation add-on assay for its DermTech Melanoma Test effective March 1. TERT mutation testing had originally been offered as an adjunct based on initial data suggesting it conferred a modest increase in negative predictive value over the two genes — LINC00518 and PRAME — assessed by the firm's baseline assay. However, in the clinical setting, DermTech has found that less than one-third of patient samples contain sufficient genomic material for TERT analysis. In addition, the company's Trust 2 Study found that added TERT analysis decreased specificity slightly without providing a statistically significant increase in negative predictive value. 

Swedish firm Devyser said this week that it inked deals with a UK-based diagnostics firm and an Italian hospital. The firm said its US-based CLIA-certified laboratory, Devyser Genomic Laboratories, signed a two-year agreement worth upward of SEK 25 million ($2.4 million) to provide Cyted's tests in the United States. The agreement includes Cyted's Heartburn Health Check with EndoSign esophageal health tests. Devyser also has won a SEK 1.5 million tender to supply cystic fibrosis transmembrane conductance regulator (CFTR) gene fragment analysis products to the University Hospital in Verona, Italy. The tender is for 12 months. 

Centogene this week reported preliminary full-year 2023 revenues of between €48.5 million ($52.8 million) and €49.0 million, reflecting growth in the mid-single digits compared to 2022. In a statement, CEO Kim Stratton said 2023 "was a year of focus and transformational changes for Centogene," citing its JV in Saudi Arabia and a lag in pharma program timelines, which impacted the firm's pharma segment revenue. "Heading into 2024, our pharma order book is set to hit new record levels," she said. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.