While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The test, TruGraf, assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection in patients with stable renal function.
Reuters reports on the growth of genetic testing fraud in the US that targets senior citizens.
While the news of the BARDA contract drove a surge in T2's stock price, it was last month's NTAP decision that has company officials and analysts encouraged.
CBS This Morning highlights recent Medicare fraud involving offers of genetic testing.
The study said that Cologuard was an "inefficient screening option" for colorectal cancer given its cost as compared to other CRC screening methods.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
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 Centers for Medicare & Medicaid Services announced it would cover approved CAR-T therapies for Medicare patients, according to the Associated Press.
The company attributed the revenue decline to a 96 percent drop in licensing revenues, which more than offset a 36 percent increase in product sales.
By studying koalas and a retrovirus that infects them, researchers may have uncovered a new sort of 'immune response' that occurs at the genomic level, Agence France Presse reports.
23andMe has a holiday popup shop at a mall and could open additional stores, Bloomberg reports.
NPR reports that the first person in the US given a gene editing-based therapy for a genetic disorder is heading home.
In Science this week: ancient genomes reveal social inequality within individual households, new method for quantifying genetic variation in gene dosage, and more.