Saladax is asking the FDA review the kit for the total measurement of risperidone in patients to monitor drug levels order to aid in managing patient adherence.
According to the company, the designation will help speed potential FDA approval of the test, which uses Ceres' Nanotrap technology to diagnose Lyme disease.
It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.
The Early Sepsis Indicator is intended to provide clinicians information about sepsis and the risk of developing sepsis in patients in acute care settings.
The company intends to use the funds to support submission of its NGS assay to the FDA, adoption of its testing by more health systems, and continued R&D.
Service revenues were down 8 percent year over year, product revenues grew 26 percent, and revenues from the transfer of intellectual property inched up less than 1 percent.
The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.
The company has also developed two liquid biopsy cancer test, Liquid GPS Core for DNA and Liquid GPS Expression for RNA.
Among the diagnostic firms presenting at the conference on Tuesday were lab giant LabCorp, diversified medical products firm Hologic, and MDx startups, such as Adaptive Biotechnologies.
The company said that if it receives 510(k) clearance it will file a CLIA waiver, which would allow the test to be used at the point of care.