The company also estimated full-year 2017 revenues to be between $23.7 million and $24.0 million, and announced a $15.8 million contract in Ethiopia.
The company's HIV testing revenues were up 24 percent year over year, while HCV testing revenues plummeted 68 percent.
The companies plan to market an HIV rapid test using a single drop of blood that leverages Atomo's lateral-flow platform and Access Bio's rapid test.
With WHO prequalification, global health organizations can consider the Aptima HIV-1 Quant Dx for public-sector procurement in resource-limited countries.
The agency updated its guidance for samples tested using nucleic acid testing, saying the technology has improved detection for the viruses.
The firm has completed a US clinical trial for a test that detects antibodies to HIV types 1 and 2 and Treponema pallidum, the causative agent for syphilis.
Ortho said that its infectious disease menu has been expanded by clearance of the Vitros HIV test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen.
The approval by WHO's Expert Review Panel for Diagnostics makes the test eligible for procurement by organizations that can access Global Fund and Unitaid resources.
Bio-Manguinhos is responsible for the development and production of vaccines, reagents, and biopharmaceuticals for public health use in Brazil.
The sequencing-based panel runs on the firm's Sentosa workflow and detects genomic mutations in the HIV virus.