The German biotech firm said its lateral flow blood test does not detect subclinical HPV infection but picks up on HPV-induced cancers and pre-cancers.
The advent of high-throughput antigen testing is especially timely as global regions are suffering second and third waves of infections during the coronavirus pandemic, Ortho said.
Following FDA's revocation of the firm's antibody-based test for the coronavirus in June, Chembio is seeking new EUAs for an antibody and antigen test for SARS-CoV-2.
The company plans to launch a test that leverages unfolded p53 as a biomarker for detection by mass spectrometry in a US-based CLIA-certified lab late next year.
The company said that at a time of unparalleled growth, it is building three new manufacturing lines and expanding resources for future assay development.
The group is developing a test that uses a spectroscopic technique called surface-enhanced Raman scattering to provide rapid results at the site of injury.
The company said it could produce 3 million antigen tests before the end of this year and between 15 million and 20 million tests per month starting next year.
