Agena has an ongoing partnership with Guangzhou-based DaRui to develop MassArray-based diagnostics for cancer and inherited diseases for the Chinese market.
The a single-tube, multiplex real-time PCR-based MeltPro High Risk HPV test identifies 14 high-risk genotypes of human papillomavirus and was previously CE marked.
The firm said that the assay uses vaginal or rectal swabs to identify Group B Streptococcus DNA in about an hour. It has filed for 510(k) clearance with the US FDA.
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.
The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The PCR assay is intended to help detect TB-causing bacteria and determine if it harbors mutations associated with isoniazid and rifampicin resistance.
The agency issued draft guidance on minimal residual disease as a biomarker and finalized another guidance on developing drugs with pan-cancer indications.
The BioCode GPP tests for 17 of the most common bacteria, viruses, and parasites that cause infectious diarrhea, and runs on the BioCode MDx-3000 system.
