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The company uses artificial intelligence to detect metabolic patterns from urine samples that indicate prostate cancer.
The agency granted clearances for tests for cancer and precancer disorders, infectious respiratory diseases, and risk of sepsis and septic shock, among others.
The clinical lab giant is working with MD Anderson on an LDT for assessing cancer risk to drive uptake of recommended screenings and identify high-risk individuals for evaluation.
Last week, readers were most interested in a story about the FDA's decision not to appeal a court decision vacating the agency's LDT rule.
The work will focus on addressing unmet needs in breast cancer, including the diagnosis and treatment of patients with rare cancer subtypes.
The test is the last of three multiplex bloodstream infection panels that the firm has designed for its Liaison Plex molecular testing instrument.
The protein biomarker-based test will be used to identify patients at high risk of cancer in order to prioritize them for conventional cancer screening methods.
The three-year award from the National Institute for Health and Care Research will support finalization of the test as well as initial validation studies.