Description
The Centers for Disease Control and Prevention intends to issue a sole source purchase order to Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN 46256-1025, to continue an ongoing project using linear array genotyping and detection kits in funded studies in human papillomavirus including the following: SUN (Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy), VSD (Vaccine Safety Datalink), EDRN (Early Detection Research Network), NHANES (National Health and Nutrition Examination Survey), a study of HPV in screening samples from two large HMOs, and the WHO Global Reference Laboratory serving as reference laboratory for the WHO HPV Labnet. Human papillomavirus (HPV) is the most commonly sexually transmitted infection, and, because of its etiologic role in cervical cancer, is a significant public health issue. HPV is not a single virus, but is a family of more than 100 closely related viruses. The types vary in their predilection for infection of mucosal or squamous surfaces. There are about 40 mucosal types, with 37 being most frequently detected in the genital tract. Of these types, 22 are called “high risk” based on their detection in cancer, and 15 are “low risk” because they are rarely found in malignancies. HPV cannot be cultured in conventional systems, so studies to understand the natural history and pathogenesis of HPV require molecular testing. In order to systematically study all 37 important types of HPV, consensus PCR methods with subsequent type-specific hybridization of the product are used. Consensus PCR uses a defined mixture of primers targeting the most conserved region of the HPV genome (L1). Type-specific detection is required to study the epidemiology, natural history and pathogenesis of the virus. In addition, since the approval of a vaccine against HPV 6, 11, 16 and 18, studies of the type distribution of HPV in lesions and in the general population are required to evaluate the impact of vaccination. A stable supply of commercially prepared and validated reagents is required to assure the sensitivity, specificity and reliability of HPV testing. The product required must be able to detect and type the 37 genital-tract HPV types and the same testing method must be used to assure that changes in type-distribution reflect changes in the population rather than changes in the method. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 6.302-1 and 6.302-2. Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.