The test, which detects antibodies to Ebola virus from whole-blood samples and cadaveric oral fluid, was also granted breakthrough device designation.
The agency plans to evaluate newer RDTs in the future, and it is collaborating to bring molecular testing nearer to patients.
The company developed the test with Boston University researchers as part of an effort to push its surface-enhanced Raman scattering tech for POC applications.
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.
Participants at the Next Generation Dx Summit last week noted that POC testing could prove vital in diagnosing and containing highly infectious diseases.
To combat the challenge of counterfeit diagnostic tests, IBM scientists have developed a method to embed security codes to authenticate diagnostic tests.
An OpenArray panel designed to simultaneously test for 17 viruses and 13 bacteria and protozoa was able to detect pathogens from human blood donor samples with an accuracy of about 95 percent.
The collaboration also includes the Viral Hemorrhagic Fever Consortium, a non-profit organization headed by Tulane University.
The Belgian MDx firm's sights are set on assays for cancer, infectious disease, and sepsis, as well as new iterations of its flagship Idylla platform.