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Comment by tlb | Hacker News Reader

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.

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That's not true for tests developed in the lab they are used in.

In 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

  Offering a diagnostic test without FDA approval is illegal

Only if they charge for it.

You're not considering the upside of relaxing these regulations. There are far more legitimate labs than there are theranoses.

You're not considering that a big part of the reason for that might be due to the regulations!

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