The firm said that its multiplex point-of-care test uses 10 microliters of blood from a fingertip and provides quantitative results in about 15 minutes.
The funding will support development of a test for the Zika virus using Ontera's silicon nanopore-based molecular diagnostics platform.
The agency said that it is the first diagnostic test for detecting Zika virus immunoglobulin (IgM) antibodies that it has allowed to be marketed in the US.
The approval advances Chembio’s commercial agreement with Bio-Manguinhos to develop and supply rapid diagnostic tests for Zika, dengue, and chikungunya.
Group K said that the partners are developing a RT-LAMP system for use at the point of care in resource-limited areas where real-time RT-PCR is not available.
The company has initial financing of $35 million, and has licensed its foundational SHERLOCK and INSPECTR technologies from the Broad and Harvard, respectively.
The mass spec-based assay can detect viral proteins eight days after the onset of symptoms, compared to four to five days with PCR tests, its developers said.
The test is designed to identify and differentiate between Zika, dengue, and chikungunya in serum samples, even in the presence of more than one target.
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 test is designed to detect the presence or absence of the Zika virus in serum or plasma collected alongside urine from patients with suspected infection.