Human Papillomavirus (HPV) testing in serum samples

1.0    DESCRIPTIONThe U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Infections and Immunoepidemiology Branch (IIB) plans to procure services, on a sole source basis, from the German Cancer Research Center, Deutsches Krebsforschungszentrum (DKFZ), Im Neuenheimer Feld 280, 69120 Heidelberg, Germany.The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1)(i); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 and the small business size standard is $16.5 million.It has been determined there are no opportunities to acquire green products or services for this procurement. 2.0    BACKGROUNDThe U.S.

Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Infections and Immunoepidemiology Branch (IIB) requires the testing of 1000 samples that were previously collected in the NCI’s ESCUDDO trial (Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ClinicalTrials.gov NCT03180034) for the detection of oncogenic HPV types using the multiplex pseudovirion neutralization (PBNA) assay.3.0    SCOPEThe Contractor shall provide all personnel, labor, facilities, materials and equipment necessary to perform the required tasks described in section 4 below. This purchase order includes services to test 1000 serum samples from stored serum samples from the ESCUDDO trial using the multiplex pseudovirion neutralization (PBNA) assay at the German Cancer Research Center (DKFZ). The Government will provide aliquots samples to the Contractor no later than 60 days after award. The Government shall be responsible for shipping samples to the Contractor and for any fees associated with shipment. The Government shall be responsible for the safety and security of the samples until successful delivery to the Contractor.Onsite services are not included in this order. Travel expenses are not authorized under this order. The Contractor shall not be reimbursed for any travel expenses or incidental expenses related to travel (e.g., parking fees).The multiplex serology assay should be identical to those performed previously (HHSN261201500002I, HHSN261201800782P), with any differences to the pipelines discussed and agreed to beforehand. The Contractor shall communicate with the study NCI scientific contact regarding any problems or difficulties arising with this work. Any deviation from the inputs determined by the Contractor and the Government as part of this task shall be discussed and agreed upon by NCI before the changes to the pipelines are applied. The Contractor shall confer as needed, by phone or email, with the study NCI scientific contact to discuss any technical issues with study tasks and any unexpected or urgent changes in study activities. Results will be provided in a file made available through encrypted email, or other agreed upon methods of data transfer.4.0    PURCHASE ORDER REQUIREMENTS4.1    TASKSThe Contractor shall perform the following tasks:4.1.1     RECEIVE THE SAMPLES SHIPMENT FROM NCIThe Contractor shall store the samples immediately upon arrival at the proper temperature (-20° Celsius) until the multiplex PBNA assay is conducted.4.1.2    PERFORM MULTIPLEX PSEUDOVIRION NEUTRALIZATION (PBNA) ASSAY FOR HPV DETERMINATIONConduct the multiplex PBNA assay in 1000 biospecimens. The Contractor shall ensure proper disposal of any residual samples.4.1.3    PROVIDE TEST RESULTS TO THE NCITest results shall be delivered to the NCI Technical point of contact (TPOC) via encrypted email.  The data files shall be provided as Excel files. No personally identifiable information shall be included.4.2    PROHIBITION AGAINST PERSONAL SERVICESThe Contractor shall not perform personal services under this contract. Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction. The Government shall not supervise or direct Contractor employees in the performance of their assignments.If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.The Contractor shall not perform any inherently governmental functions under this contract. No Contractor employee shall represent or give the appearance that he or she is a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government.The Contractor is responsible for ensuring that all employees assigned to this contract understand and are committed to following the requirements of the Contract.5.0    TYPE OF ORDERThis is a firm fixed price purchase order.6.0    NON-SEVERABLE SERVICESThe services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government.7.0    PERIOD OF PERFORMANCEThe period of performance shall be for twelve (12) months from the date of award.8.0    PLACE OF PERFORMANCEServices shall be performed at the Contractor’s facility.9.0    REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULEThe Contractor shall submit the test results in a Microsoft Excel-compatible file for review, comment, and approval by the NCI Technical Point of Contact (TPOC) fifteen (15) calendar before the final report is due. The result shall be reported for each HPV type and protein as either positive or negative. Quality control samples are included in the specimen number. Final copies of the approved draft(s) shall be delivered to the TPOC within five (5) business days after receipt of the Government’s comments.The TPOC for this order is:(TBD AT AWARD)All deliverables shall be provided in accordance with the following deliverables schedule:DELIVERABLE      Task 1:         DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTSDetection of oncogenic HPV types using the pseudovirion neutralization (SEAP) assay in 1000 specimens from ESCUDDO participants. Test results shall be delivered to the project officer via encrypted email.  The data files shall be provided as Excel files.DUE DATE30 calendar days after receipt of the order10.0    UNIQUE QUALIFICATIONS OF THE CONTRACTORThis requirement includes testing of 1000 stored serum samples from the ESCUDDO trial using the high-throughput pseudovirion neutralization (HT-PBNA) assay at the German Cancer Research Center, Deutsches Krebsforschungszentrum (DKFZ). DKFZ developed and validated the high throughput PBNA assay for the necessary HPV genotypes and proteins. In addition, DKFZ has tested samples from the same study under purchase orders HHSN261201700539P, and HHSN261201800782P.  It is critically important to use the same laboratory for the current requirement to ensure scientific comparability of the new results with the results from the studies previously conducted. Additionally, this assay has been extensively validated to ensure reliable results. The validation study demonstrated that HT-PBNA performed exceedingly well with respect to both reproducibility and agreement with simplex neutralization assays for HPV-16/18 and it is now the gold standard assay (Tsang S, et al. Vaccine 2020 Aug 27;38(38):5997-6006. doi: 10.1016/j.vaccine.2020.07.017. Epub 2020 Jul 24). Other laboratories cannot perform the same validated HT-PBNA assay and attempting to do so will result in delays as new assays will need to be developed and validated before any can be used as a new goal standard.To date, high-throughput detection of HPV capsid-specific antibodies has been possible only with the aid of surrogate detection assays such as ELISA (like the NCI’s Frederick National Laboratory multiplex ELISA) and competitive Luminex immunoassay (cLIA) using VLPs as antigen. DFKZ is the only lab that has developed a purely add-on system in which the serial dilution of serum samples is separated from the cell-based assay, providing a high degree of flexibility. The high-throughput assay demonstrates high robustness with little intra- and inter-assay day variability. The HT-PBNA has higher sensitivity compared to the manually performed assay using secreted alkaline phosphatase (SEAP) as reporter. In its current format, the neutralization titer of 110 serum samples for seven HPV types can be determined in a single run. The HT-PBNA allows the execution of large studies on vaccine- and naturally-induced immunity against HPV infections.NCI/IIB uses the HT-PBNA to compare results using other serological assays conducted at the NCI. By using the DFKZ’s goal standard assay, the reliability of other serological assays can be confirmed which will provide assurance that other studies using these assays obtain reliable results, which will be a direct benefit to the U.S. government and the public.11.0    SUBMISSION INSTRUCTIONSThis notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, 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.  All responses and questions must be sent via email to the Contract Specialist, Dana Summons, at dana.summons@nih.gov by no later than 3:00 PM EST on December 7, 2022 (12/7/2022). 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. In order to receive an award, Contractors must be registered and have valid certification through SAM.gov. Reference: 75N91023R00026 on all correspondence.