CE mark

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.

Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.

The China-based company said that it now has 11 products that have been CE marked, and has applied for additional CE certification for other tests.

The firm will manufacture its Logix Smart mycobacteria tuberculosis assay at its ISO-certified facility in Utah but will not seek FDA approval at this time, it said.

The multiplex real-time PCR assay enables the simultaneous detection of Trichomonas vaginalis or Mycoplasma genitalium in urine and vaginal samples.

BioGx now offers 11 CE-marked infectious disease tests that run on Becton Dickinson's BD Max platform.

IncellDx HPV OncoTect 3Dx system combines the quantification of oncogene mRNA overexpression, proliferation, and aneuploidy in one high-throughput assay, according to the firm.

The company submitted the platform and gastrointestinal panel to the US Food and Drug Administration for clearance earlier this year.

Amplidiag CarbaR+MCR detects the main carbapenemase-producing organisms and colistin resistance markers. Novidiag Bacterial GE+ identifies the most common enteric pathogens.