CLIA Waiver

There is a lot of misperceptions from people on HC and Twitter around the CLIA waiver approval time frames because they don't read everything and don't watch everything from the company. To ensure clarity on here:

LAST PATIENT: We need 120 bacterial positive patients to submit for CLIA waiver. On release of the quarterly report on the 21st July, the company had reached 105/120 patients. HOWEVER, in the webinar presentation, Doug (CEO of Lumos) advised holders who did sign in any pay attention, that the company was at 112/120.



Projected Timeline:

The time frame now means they are slightly overdue in release of the last patient.

This could be due to:
- Lack of bacterial positive patients
- Delayed release of final patient update (they could be compounding multiple updates here such as last patient and submission simultaneously). The last patient in doesn't really quantify a market sensitive announcement and it is already knowledge on the process they need to complete. It makes sense to bulk an announcement to the market.

The company also announced in said webinar that they intend to submit for CLIA waiver end of August/Early September. The time frame for FDA determination with NO requirement for additional clarity on submissionis 90-150 calendar days. It is important to understand this. This projects the time frame at:

90 days: November 2025

150 days: January 2026

It is also important to note that the waiver requires the test itself just needs to prove it can achieve the same results with trained v untrained users. Review the image below and tell me whether anyone with half a brain cell can use and read this test:



1. Push the test device into the tip of the finger. Automatic need pricks the finger and draws blood.
2. Place the collection tube into the blood to collect the full tube of blood.
3. Flick the buffer release down
4. Click the buffer control release - blood then flows onto the test strip.
5. 10-15 minutes, lines appear like a pregnancy test to determine bacterial or viral infection.


So, unless you are colourblind (which still wouldn't be an issue if you know where the required lines are on the test) you would have a simple result.

The test is already FDA approved meaning the test shows enough in prior trials to evidence its ability to provide a result. The current study is to prove two different users can use the test and produce the same outcome. The test will do what its intended to do. Its to prove the untrained user can follow the 5 steps.

In summary:

Lumos Diagnostics is nearing completion of its CLIA waiver patient requirement (112/120 as of the July 21 update) and plans to submit by late August or early September, with FDA review expected to take 90–150 days (November 2025–January 2026). The waiver simply confirms that untrained users can operate the already FDA-approved test and achieve the same results as trained user s. The later date of January would only be if additional information is required or insufficient information provided to determine a result.

The FDA will engage in a Substantive Interaction (SI) within 90 FDA review days. The SI may be an email or letter notifying the applicant that the CW has been Approved.

You can track this here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/results.cfm