CE mark

The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.

With CE-IVD marking, the melt curve analysis-based screening assay is available for sale in the EU and other areas that recognize the designation.

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 PCR assay is intended to help detect TB-causing bacteria and determine if it harbors mutations associated with isoniazid and rifampicin resistance.

The kit is designed to quantify HIV-1 RNA in blood samples and runs on Bioneer's PCR-based ExiStation automated molecular diagnostics system.

The firm's molecular assay directly detects varicella-zoster virus DNA from a patient's cerebrospinal fluid and provides results in about one hour.

The firm reported a 69 percent increase in product sales, driven by a 102 percent jump in cartridge sales and jump in research revenues.  

The QuantideX NGS DNA Hotspot 21 kit is designed for use on the Illumina MiSeq platform and screens for 21 common genomic variants across a variety of cancers.