Solei Systems Inc. (fka SOLI)

[daiello]

The Company initially chose to work with a lab that used an FDA approved SARS-COV-2 Coronavirus test that met the FDA Emergency Use Authorization criteria. That lab is Next Molecular Analytics, a 23-year-old laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). We relied upon the following communication from Next:

“We are pleased to announce NEXT is launching an FDA approved SARS-CoV-2 Coronavirus test for COVID-19 detection. This test meets the FDA Emergency Use Authorization (EUA) criteria as it consists of the CDC developed RT-PCR assay. This EUA allows the assay to be performed in CLIA high complexity laboratories, a classification that NEXT meets. NEXT has worked tirelessly over the past few weeks to obtain the assays and validate so that we may perform testing for those patients that physicians feel meet the requirements for testing.”

Also, Melissa Russell - Director of Clinical Business Operations said, “NEXT [Molecular] will be responsible for sending kits to patients overnight and for providing materials to overnight those samples back to our facility for testing.”