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Diagnostics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

Beyond its HostDx Sepsis test, the firm is working on a test to detect and differentiate bacterial from viral infections in patients presenting with fever.

Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.

The firm said its platform provides sample-to-answer results for two of the most frequently tested sexually transmitted infections, enabling rapid testing and treatment.

The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.

The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.