They need CLIA Waiver to be able to do that based on complexity...

They need CLIA Waiver to be able to do that based on complexity of the test.

They have a pathway identified with the FDA to obtain CLIA waiver which may involve some more tests. No time frame indicated on receiving this.

You can follow here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/results.cfm and see the waiver status. Until it is changed from moderate to waived (which an announcement likely before you see this change) we are restricted to 10,000 labs.

As mentioned in the last webinar, they are filling an average of 8 distributor orders a month and meeting capacity for their product at present.

My estimate is 50,000 tests per quarter based on the AT1 sales (refer to recent quarterly for AT1) to LDX and NG Biotech for the same pascal device: https://www.atomodiagnostics.com/technology/our-partners/

50,000 pascal units to Febridx tests based on 25 per box would be around 2000 tests a quarter. $450 a box would be $900,000 a quarter in revenue gross.