66--ALLEGRO AUTOMATED (FLUROSCENT MODE) SCANNER SYSTEM

In accordance with FAR 6.302-1, the Michael E. DeBakey VA Medical Center, Houston, TX, intends to negotiate on a sole source basis with BioView, a firm fixed price contract for a Automated Fluorescent Mode Scanner System. Vendors may identify their interest and capability to respond to the requirement; however, this notice of intent is not a request for competitive proposals. Responses must be received no later than 5 days from the date of this notice. Requirements include: The system should include an automated microscope with motorized 8-slide stage capable of fluorescent illumination, a 3-CCD color camera, and flat, high resolution display monitor, and a color printer. The system should also include an additional workstation for case review and analysis. Applications to be run on the system are for bladder cancer and breast cancer (Her2/neu), and prostate cancer, with possible additional applications in the future. The system should be able to scan voided-urine samples, cell suspensions and tissue. Regulatory Clearances: Instrument system requires FDA 510k clearance for the classification of cells based on their size, shape and color. The indications for use should be: 1) To detect cells in urine specimens stained by FISH for chromosomes 3,7,17 and 9p21 locus from subjects with transitional cell carcinoma of the bladder. 2) To 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.