Kelsy Ketchum
Articles Authored by Kelsy Ketchum
After Series A Financing, Digital Pathology Firm PathPresenter Looks to Broaden Commercialization
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The firm raised $7.5 million in its financing round and plans to use the money for further development of its platform and regulatory milestones.
The Temperature-Activated Generation of Signal (TAGS) technology was developed by Roche for its high-throughput PCR-based instruments.
The firm has submitted its xR assay to the FDA and is prioritizing its entry into the minimal residual disease space.
The test assigns a pancreatic cancer subtype based on the expression of 16 genes measured using an array.
The machine learning framework extracts features from digital pathology slides to diagnose and predict multiple types of cancer.
After Positive Trial Results, Accelerate Diagnostics Prepares for Launch of New AST Platform
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The firm's Wave platform uses digital holographic microscopy to return antimicrobial susceptibility test results within five hours.
FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
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The plan, announced in January, would reclassify many Class III in vitro diagnostic devices as Class II, impacting companion diagnostic and infectious disease tests.
The analyzer can perform hematology, immunoassay, and clinical chemistry testing from a single blood sample.
The firm's full-year 2024 revenues were up 2 percent year over year and in line with the consensus Wall Street estimate.
The organization's priorities also include developing appropriate pediatric reference intervals for diagnostic tests.