Cysview (Hexaminolevulinate Hydrocholride) for Intravesical Solution

Description The NCI, Urologic Oncology Branch (UOB) plans to procure on a sole source basis with Photocure, (202 Carnegie Center - Suite 204, Princeton, NJ 08540-6239) to provide the optical imaging agent, Cysview (hexaminolevulinate HCl), which is the only FDA approved product for use with blue light cystoscopy. Cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnosis (PDD) system to perform cystoscopy with the blue light setting as an adjunct to the white light setting. Photocure is the only known source that provides the compatible reagents since Cysview for Intravesical Solution is a unique optical imaging agent. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 424210 and the business size standard is $14.0 Million. The Urologic Oncology Branch (UOB) conducts clinical and basic research designed to develop better methods for detection, prevention, and therapy of patients with genitourinary malignancies. Its primary focus is the study of the genes associated with initiation and progression of kidney, prostate, and bladder cancers. The use of the optical imaging agent Cysview (Hexaminolevulinate Hydrocholride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have lesion(s) on the basis of prior cystoscopy. Blue light cystoscopy is the most advanced method of diagnosing and detecting bladder tumors. It has been shown to enhance one's ability to identify bladder tumors over conventional white light cystoscopy. UOB needs to be able to offer blue light cystoscopy to better detect and treat bladder tumors for clinical trials and improve patient care. Blue light cystoscopy requires the optical imaging agent Cysview (Hexaminolevulinate Hydrocholride) for Intravesical Solution, sold through specialty pharmaceutical company Photocure, to carry out the photodynamic blue light cystoscopic examination of the bladder. The Urologic Oncology Branch (UOB) is interested in conducting clinical and basic research designed to develop better methods for detection, prevention, and therapy of patients with genitourinary malignancies. The primary focus is the study of the genes associated with initiation and progression of kidney, prostate, and bladder cancers. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Anticipated Period of performance shall be from September 26, 2014 through September 25, 2015. It has been determined there are no opportunities to acquire green products or services for this procurement. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST, on September 9, 2014. All responses and questions must be in writing and faxed to 240-276-5399 or emailed to Jonathan Rudd, Contracting Specialist via electronic mail at jonathan.rudd@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02RC44703-97 on all correspondence.