The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said.
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.
Hallmarks of the genetic disease, which can result in life-threatening cardiac complications, include progressive weakness and loss of heart muscle.
The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said.
The organizations noted in a letter to HHS and FDA that they "believe the agency's actions may in fact inflict greater harm on patients and impede innovation."
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.
The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.
An analysis in JAMA Network Open examines regulatory approvals not based on randomized clinical trials.
Janet Woodcock, the director of the Center for Drug Evaluation and Research at the US Food and Drug Administration, says changes are needed for all benefit from biomedical advances.
23andMe has a holiday popup shop at a mall and could open additional stores, Bloomberg reports.
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.
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.