Natera is preparing for the pace of its prospective study readouts to "accelerate meaningfully" over the next few years to potentially demonstrate the clinical utility of its Signatera test, company ...
The clearance also includes a predetermined change control plan to lower regulatory hurdles around changes to the software's use.
The company also submitted a request for a CLIA waiver for the test, which would permit its use in decentralized testing locations.
The technology supports the adoption of digital pathology and artificial intelligence in cancer diagnostics by enabling greater consistency in laboratory slide staining.
Cancer early detection firm Grail said after the close of the market Wednesday that its second-quarter revenue grew 26 percent year over year, noting that it is preparing for an expected advisory ...
The issue of developing pediatric reference intervals for common laboratory tests has been one of the organization's priorities.
The test received PDMA approval for colorectal cancer in June, making it the country's first PMDA-approved MRD test.
Executives disclosed new directions in neurodegenerative disease testing and low-volume sample collection for high-volume testing.
The firm also offered updates on its autoimmune disease, newborn screening, and other specialty diagnostics businesses from the sidelines of the conference.
Last week, readers were most interested in a story about a staffing shortage at labs that run liquid biopsy tests as demand for the tests skyrocket.
The Chicago-based company is developing a POC field-effect transistor (FET)-based analyzer that it plans initially to target to the fertility testing space.
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