FDA Watch: Could Guardant Health’s Colon Cancer Assay Be a Blockbuster?
The company is hiring at least 100 sales representatives this year to spread awareness and uptake of its recently FDA-approved Shield test
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FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
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Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
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FDA Watch: Key Lab Test Clearances of 2023
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
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Diagnostics Pipeline: FDA Opens Path for Blood Tests Assessing Genetic Cancer Risk
First marketing authorization of a blood test assessing genetic variants related to cancer opens the door for clearance of similar tests.
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