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 NAM, NAS, and Royal Society have formed a commission to develop a framework on the proper use of genome editing, and convened its first meeting in Washington, DC, this week.
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.
At a meeting this week, researchers and others discussed the regulatory oversight needed for germline genome editing.
The US Food and Drug Administration has asked questions about Myriad Genetics' GeneSight test, according to Bloomberg.
Researchers report that neutrophil extracellular traps appear to binds gallstones together, according to New Scientist.
In Science this week: approach to infer genotype-by-environment interaction from genetic variants associated with phenotypic variability, and more.