According to the company, the designation will help speed potential FDA approval of the test, which uses Ceres' Nanotrap technology to diagnose Lyme disease.
The test is intended for use as the initial screen in the two-step testing process recommended by the CDC for detecting antibodies against B. burgdorferi.
The new funds, which the company said it will use to develop its Nanotrap Lyme Antigen Test, bring its Series A Round proceeds to a total of $8.5 million.
The workflow — which involves two immunoassays instead of the standard immunoassay followed by a Western blot — was tested using the agency's Lyme Serum Repository.
The firm said that sales growth was impacted by immigration headwinds, severe winter weather in the US, and unfavorable order timing in Asia.
The company claims its test can detect the Lyme-linked chemokine CXCL13 in human cerebrospinal fluid within 20 minutes.
The test was previously cleared to run on the Sofia platform and can rapidly differentiate human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens.
Prompted by an FDA letter requesting additional clinical testing, the firm expects to shut down its development of a babesia blood-donor screening assay.
A broad team of researchers has developed a microarray that looks for 171,000 different peptide fragments to differentiate among tick-borne diseases.
Luminex was bullish about its molecular diagnostics business, Natera outlined its work with pharmaceutical firms, and Oxford discussed its plans in TB and tick-borne diseases.