After we published our initial paper describing a diagnostic test for ALS, the Centers for Disease Control (CDC) agreed to send us 50 additional blood samples from patients diagnosed with ALS.
Comparing these to 50 blood samples from people who did not have ALS, we were extremely encouraged to find that five of the eight of our original microRNA sequences for ALS were verified. This gives us greater confidence in the sensitivity of our diagnostic assay.
To add to this, and importantly, the CDC blood samples were collected by physicians who did not have, as we did, -80°C freezers to protect the microRNA from degradation. Unlike our first 20 samples, these 50 were not collected following the stringent protocol we designed in our clinical trial.
This is important because it suggests the miRNA might be resistant to degradation, adding to the robustness and application of the assay.
The CDC has now sent us an additional 100 ALS blood samples which we will compare to 100 samples from people who have not been diagnosed with ALS.
This will confirm our ALS blood test if we get the same results.
Ultimately, we are hoping to attract the interest of a commercial diagnostic lab that has the resources to deliver this test into the hands of clinicians and patients who so desperately need a faster and more efficient way to diagnose ALS.