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Comment by throw7337 | Hacker News Reader

There is nothing secret about RNA testing. Any decent lab can synthetise its own markers from a file downloaded from internet. It is like genetic research is illegal in US or what.

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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.

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

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!

  Offering a diagnostic test without FDA approval is illegal

Only if they charge for it.

1) Regulatory issues

2) The reagents needed for the testing are also in extremely short supply, and labs are having a hard time getting more. So, you can develop a test, but your testing capacity will remain limited.

Chloroform, phenol, and water are all availible in tanker car quantities.

Column based RNA purification is more reliable and more appropriate in a clinical lab. Qiagen is triple* overtiming production to meet demand.

*unscientific guess for literary effect

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