I sent an email to the Company asking if they had submitted the complete technical package to the Centres for Medicare and Medicaid Services (CMS) for review and approval.
This is their response: "we are waiting on Cross Validation data to complete the regulatory pack. The initial test was built on 1500 patient sample data and a similar figure is required to complete the cross validation from an independent data source. The company has been working hard to secure such data based on existing and new relationships. Upon receipt of the data and submission of the Technical Pack, we have been informed that regulatory approval should take approximately 30-45 days"
So we are at least two months away from this Covid approval.
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