Why is every lab making its own version of the corona virus antibodies?
Johnson and Johnson and Moderna are a few, and maybe another overseas, but which one will be used and how will the doses be consistent if you have more than one company making them to sell to the USA and other countries. Please explain, thanks!
- Lab GuyLv 62 months agoFavorite Answer
Allow me to explain. Normally any test under normal circumstances must submit lots of studies to the FDA in order for it to be allowed to be released for medical use in the US. Insurance companies won't pay for them otherwise. A lab can still perform the test but must label it as for research purposes only and the cost is out of pocket for the individual.
Because of the pandemic the FDA put test for COVID 19 under Emergency Use Authorization and so studies were set aside until later and that was so tests could get out as fast as possible because of the urgent need for such tests.
As a result of the EUA many companies saw an opportunity to make money and get their tests out there before the FDA starts cleaning house and shutting down because of poor accuracy. Labs are competing for the business and through competition the best can be selected.
In the US there is no monolithic supply chain or selection of one large manufacturer for all testing. It is hoped that competition can reduce costs.
There is no standardization of testing in general. Multiple manufacturers are preferred in order to reduce costs. There is no one single payer federal healthcare system that buys millions of tests from one manufacturer. Healthcare in the US is private.