Celerion has obtained the Clinical Laboratory Improvement Amendments certification for its state-of-the-art bioanalytical laboratory in Lincoln, NE.

The company’s CLIA-certified lab in Irvine, California, is licensed by the California Department of Public Health and will perform the test.

The test, intended for prescription use only, can be used in CLIA-waived point-of-care settings. The latest waiver is likely to significantly boost QuidelOrtho’s Point of Care business unit.

Evvy and MicroGenDX have partnered to relaunch the Evvy Vaginal Health Test as the world's first and only CLIA-validated mNGS vaginal microbiome test.

“Successful completion of the CLIA Lab Validation Study is another important step toward launching DetermaVu™,” said William Annett, President and Chief Executive Officer.

Whether you’re a physician, a member of a digital health organization, or a potential end-user, here are five things you should know about at-home diagnostic testing.