The test detects early and late stages of Borrelia burgdorferi infection directly from patient plasma or serum within 10 minutes.
The CDC received clearance for a number of influenza panels and kits. Agilent's assay for postnatal CNV detection, and Abbott's hematocrit test were also cleared.
Under the terms of the agreement, Innatoss becomes the exclusive provider of Ceres' Nanotrap Lyme Antigen Test in a variety of EU companies.
Researchers used mass spectrometry to identify unique biochemical markers that differentiate Lyme disease from southern tick-associated rash Illness.
The diagnostic firm plans to sell the shares to BTIG. It also has granted the investment bank the option to purchase up to an additional 375,000 shares.
Market growth is providing opportunities for emerging diagnostic companies and a range of options for clinicians, included PCR and protein tests.
The firm remains on track to file for FDA clearance of its T2Bacteria panel, which its CEO called a "game changer" by mid-2017.
Crowdfunding will help move the targeted sequencing-based test through the development process in hopes of commercializing it.
The company said its product revenues rose during the fourth quarter thanks to an increase in T2Candida panel sales due to increased patient testing.
The funds, which the company said are part of a larger $9 million Series A round, will support the development of its test for early diagnosis of Lyme disease.