The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
The company received support from a Johns Hopkins University center focused on point-of-care device development for sexually transmitted infections.
The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.
The firm is developing a multipanel test and an antibiotic resistance panel to augment its recently CE marked chlamydia and gonorrhea assay.
The firm said that its point-of-care test delivers laboratory-quality results in about 30 minutes and could be used in the home and other settings.
Developers of POC STI platforms and assays said that the tests provide convenience, privacy, and quick results in an area of testing in need of these benefits.
The nucleic acid diagnostic platform they are developing doesn't require expensive optics, and it could be available as a manufacturing prototype in about a year.
The agreements involve the commercialization of the NeuMoDx 288 and 96 platforms for fully integrated, sample-to-answer, PCR-based molecular diagnostic testing.
The funding will go toward expanding the firm's product line and increasing access to its testing services. MyLab Box has raised $2.1 million in total.
The Ann Arbor, Michigan-based firm will compete with a few well-established players offering systems that can run in vitro diagnostic tests as well as lab-developed tests.