65--Intent to Sole Source to Roche Diagnostics Corporation Automated Molecular HPV Testing Closes 09/12/2019 2:00 PM EST

Notice of Intent to Sole Source The VA Pittsburgh Healthcare System, University Drive Campus, University Drive Pittsburgh, Pennsylvania has a requirement for Automated Molecular HPV Testing. These reagents/supplies will be used by the medical center on the Roche Cobas 4800 instrument to perform automated Human Papilloma Virus (HPV) testing. The VA has only located one vendor capable of providing the requested items and intends to issue a sole source contract to Roche Diagnostics Corporation. This notice is being posted so that any unknown vendors who are capable of providing these items may come forward and express their interest and capability in providing Automated Molecular HPV Testing to the VA. If your company/organization is capable of providing the required items, provide your entity s capability statement to Amanda Williams, Contracting Specialist by 2:00 p.m. EST Thursday, September 12, 2019 via email to

href="mailto:Amanda.Williams4@va.gov">Amanda.Williams4@va.gov. In addition to your capability statement also provide any applicable distribution agreements regarding Automated Molecular HPV Testing, the size, and socioeconomic status of your company, and any other information pertinent to this requirement. Reference Procurement ID number 36C24419Q1153 in the subject of the email. ***This is not a request for quote, no quotes should be sent in response to this notice. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling, and convincing evidence that competition will be advantageous to the Government. Information received will be considered solely for determining whether to conduct a competitive procurement. Statement of Need/Work: STATEMENT OF WORK HPV SCREENING AND GENOTYPING Background. Cervical cancer, formerly one of the most frequent causes of cancer death in women, currently ranks 14th in the United States. Screening with high-quality cytology or Papanicolaou (Pap) testing, has significantly reduced the mortality rate of women with squamous cell cervical cancer. The reduced mortality rate is impacted by detection and treatment of cancer at earlier stages. In 2012, approximately 12,000 women are estimated to have invasive cervical cancer and about 4,000 women are predicted to die. High-risk genotypes of the human papillomavirus (HPV) virus have been identified as necessary for development of cervical cancer. Persistent cervical infections with HPV genotypes 16 and 18 have been connected to cervical cancer and precancer cervical intraephthelial neoplasia (CIN) grade 3 (CIN3). HPV positivity has been identified in nearly all cases of cervical cancer. HPV16 is the most carcinogenic genotype causing approximately 55% to 60% of cervical cancer followed by HPV type 18 which causes 10% to 15% of cervical cancer cases. The American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP) updated screening guidelines for prevention and early detection of cervical cancer. The updated guidelines include the addition of HPV testing as part of the cervical cancer screening process. HPV testing by molecular methods offers a more sensitive option for identifying high risk individuals who need to be followed by cytology. The detection of the carcinogenic HPV types by molecular methods precedes dysplasia identifies women who need regular follow-up, those who need less frequent follow-up, and those who do not need follow-up. HPV positivity allows an increased rate of early cancer detection and less frequent testing in HPV negative individuals. Molecular HPV screening can replace Pap except on those women who have positive results. Scope. The contract will include all costs associated with performing automated molecular HPV testing. For the use of purchased reagents and disposables the contractor provides all required hardware to perform the necessary methodologies. Salient Characteristics This contract is required to provide pricing for all necessary consumables required to perform fully automated FDA cleared molecular HPV screening, 16s and 18s genotyping, and quality control materials. The selected methodology will include that only one sample is required per run. The contract will include pricing for any disposables, maintenance items, etc. to properly maintain and operate the analyzer on a daily basis. These items will be permitted to be ordered as needed. The selected vendor for HPV methodology will include a patented enzyme, Amperase, that eliminates contaminating amplicons that are often a major source of clinical molecular testing. This enzyme is unique and a significant advantage over other competing methodologies. The selected vendor will be required to be FDA approved for primary screening of individuals age 25 years and older. Task 1 Technical and Field Service The contract will include provisions for both Field and Technical Service. The contract will state that Field service will be performed Mon-Fri (8:30 A.M. to 5:30 P.M., EST) and that all issues will be resolved within a 24-hour time frame from the time service is required. Technical support is available Mon-Fri (8:30 A.M. to 5:30 P.M., EST). Task 2 Kit Configurations To maximize sample processing efficiency, it is required that the vendor provide the ability for the ordering institution to obtain kit configurations that include 240 tests/kit. Deliverables: The following routine consumables are ordered as needed. HPV Amplification/Detection Kit 05235880190 16 HPV Controls Kit 05235855190 16 System Sample Preparation Kit 0523578219 16 System Liquid Cytology Preparation Kit 05235812190 16 System Wash Buffer Kit 05235863190 16 CO-RE Tips, 1,000 Âμl 04639642001 10 System Extraction Plate 05232716001 4 Reagent Reservoir, 50 mL 05232732001 4 Reagent Reservoir, 200 mL 05232759001 2 Sarstedt Tubes 063950023001 8 Sarstedt Caps 06395015001 1 Performance Monitoring It will be the responsibility of the VA Medical center to monitor all performance issues with the vendor. Timely delivery of supplies, prompt and professional technical service, and 24 hour field service, Mon-Fri, will be evaluated and compared to the terms of the contract. Security Requirements In accordance with VA policy, contractors storage, generation, transmission or exchanging of VA sensitive information requires appropriate security controls to be in place. This is an acquisition or purchase of commodities, goods (e.g. equipment or software), and technical/field service support to maintain the analyzers. VA sensitive information will be involved in the course of these procedures (see Appendix A). Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). No GFE or GFI will be needed in any capacity. Other Pertinent Information or Special Considerations. The methodology selected will require only 2 controls per run. The method will not have any cross reactivity with low risk HPV types. The methodology will have the ability to directly report the identity of both 16/18 genotypes. The analyzer will provide automated extraction The analyzer will provide automated testing. The methodology selected will only require a 1ml sample volume. The chosen methodology will not have Grey Zone repeat testing. The selected method will not require bleaching or alcohol. The method will include Amperase to prevent the possibility of cross contamination. The method will contain an internal control for each sample. The method selected will not require reflex testing. The vendor chosen will offer all the above special considerations. A methodology that includes all of the special considerations will provide State of the Art for our veterans and reduce time to result significantly. a. Identification of Possible Follow-on Work. Not Applicable b. Identification of Potential Conflicts of Interest (COI). Not applicable. c. Identification of Non-Disclosure Requirements. This is an acquisition or purchase of commodities, goods (e.g. equipment or software), and technical/field service support to maintain the analyzers. VA sensitive information will be involved in the course of these procedures. d. Packaging, Packing and Shipping Instructions. There is no special packaging and shipping instructions required. All items are shipped as per the vendor s specifications to ensure quality of products and goods. e. Inspection and Acceptance Criteria. All received products and goods are examined for quality and acceptability without exception. Acceptable products are signed for by the laboratory. Risk Control No additional risk will be undertaken by the laboratory as compared to any other vendor or method. Place of Performance. The equipment and supplies will be located in room 2NW104 (Molecular laboratory). No contractor travel expenses are included in this contract. Period of Performance This contract will be valid for a 1-year time period. In addition, the contract should contain four additional option years. The base period of this contract should reflect 10-01-19 through 9-30-20 Delivery Schedule. All required items will be ordered as needed directly by the lab and delivered within one (1) week. All vendor shipped items will be delivered in a vendor determined format. All items will be delivered to the dock area of: VA Pittsburgh Healthcare System University Drive Pittsburgh, PA 15240