The University of Utah spinout said it will use the funding to enhance and expand its NGS-based Explify microbe identification platform and support its lab.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
The company is currently conducting clinical studies to validate AlloSure's technology — which underlies its kidney transplant test — in lung transplant patients.
The test showed 90 percent sensitivity and 75 percent specificity in a 250-patient blinded study, even without the addition of clinical risk information.
The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.
