Regulatory Approvals

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 a Korean KFDA, Australian TGA and Thai FDA approval.

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.

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