3 ms·
Offering a diagnostic test without FDA approval is illegal, for good reason (there would be companies far worse than Theranos) but clearly in an emergency regul
by tlb 7y ago
Offering a diagnostic test without FDA approval is illegal, for good reason (there would be companies far worse than Theranos) but clearly in an emergency regulators need to adapt.
- wbl 7y agoThat's not true for tests developed in the lab they are used in.
- vmh1928 7y agoIn Arizona, Mayo Clinic, Sonora Quest Laboratories, and the Translational Genomics Research Institute in Flagstaff are rolling out their own tests. Official test kits from the CDC are in woefully short supply, under 200 right now, and only being used for people showing significant symptoms. According to a news article the new tests will use a technique similar to the CDC test known as reverse transcription polymerase chain reaction, otherwise shortened to RT-PCR
- allovernow 7y agoYou're not considering the upside of relaxing these regulations. There are far more legitimate labs than there are theranoses.
- SAI_Peregrinus 7y agoYou're not considering that a big part of the reason for that might be due to the regulations!
- masonic 7y agoOffering a diagnostic test without FDA approval is illegal Only if they charge for it.