Regulatory Approvals - Automated Imaging

BioView’s DUET imaging and analysis platform has received FDA clearance for several FISH applications for cancer detection and diagnosis and detection of genetic aberrations.
Bioview products have CE Mark, as well as the Chinese NMPA, Korean KFDA, Australian TGA and Thai FDA approval.

In the United States the Duet™ System is intended to:

01. Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension.

02. Detect amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).

03. Detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via FISH in urine specimens from subjects with transitional cell carcinoma of the bladder, probed by the Vysis Urovysion™ Bladder Cancer Kit.

04. Detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis® PathVysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.

05. Qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis® ALK Break Apart FISH Probe Kit.

In USA, All other products are for research purposes only, not intended for diagnostic or therapeutic use.

In the EU, The Duet™ System intended use under IVDR:

The Duet System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist in the detection, classification and counting of cells of interests based on color, intensity, size, pattern and shape.

It is the end user responsibility to validate the Duet system use in combination with commercial reagents and materials for a specific clinical application.

The Legacy Duet™ System under IVDD, can still be marketed in the EU until May/2026.

The Duet Legacy system intended use:

01. Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension.

02. Detect amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).

06. Karyotype with real-time microscope images from cultured and stained cell specimens in their metaphase, stained with G-banding technique.

The company is continually expanding its regulatory approval reach to additional countries.
For additional information please contact BioView.