VirScan Analysis on Plasma samples

This is a combined synopsis/solicitation for commercial items prepared in accordance with the
format in FAR 12.6 as supplemented with additional information included in this notice. This
announcement constitutes the only solicitation and a separate written solicitation will not be
issued. This solicitation number is NICHD-20-248 and is issued as a Request for Quotation
(RFQ). The solicitation/contract will include all applicable provisions and clauses in effect
through Federal Acquisition Circular 2020-08. The North American Industry Classification
(NAICS) Code is 541990 and the business size standard is $16.5m. However, this solicitation is
not set aside for small business. This acquisition is being conducted using Simplified
Acquisition Procedures in accordance with FAR Part 13. Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD) intend to procure on a sole source
basis with CDI Laboratories @ Baltimore, MD services to process human patient plasma
sample using their proprietary VirScan Analysis procedure.
Background: In the Study 20-AA-N115 “COVID-19 Pandemic Impact on Alcohol (PIA) – A
Natural History Study” we are assessing the impact of the COVID-19 Pandemic on Alcohol use
in a deeply phenotyped sample of NIAAA patients. Phenotyping means collecting information
from the patient about their drinking history, physical characteristics, socially economic status,
etc. The Virscan assay will allow us to determine if a local subset of our sample of patients was
exposed to the Coronavirus causing the COVID-19 infection in the context of seropositivity for
other Type A and Type B coronaviruses, and >100 other viruses. It is already known that
heavier drinkers have different immune responses, such as ‘cytokine’ inflammatory signal
molecules. This viral history data will provide unique information how those who drink heavily
differ from the general population when analyzed with the phenotyping information.
The ANTYGEN VirScan service, developed by CDI from Dr. Elledge’s initial research and
creation, provides a unique way to assay a patient’s viral history by analyzing antiviral
antibodies to a phage library displaying peptides from 206 species and over 1000 strains of
viruses. Typically, such tests measure only one virus at a time. Using a synthetic
representation of all human viral peptides, this blood test identifies antibodies against all
known human viruses. No other known product can achieve this level of detection in a single
blood sample. To achieve the same amount of data, more patient sample would be required in
order to run multiple single-assay tests, which may exceed the volume of blood allowed to be
collected with IRB approval. Additional cost, time, and staff workload would be required if
results were collected by those other ‘traditional’ methods. In reagents alone, a PCR test can
cost thousands of dollars per molecule of study, which would limit our choice of targets
compared to the Virscan comprehensive assay. The Virscan technique was developed by Dr.
Steve Elledge’s Harvard laboratory. Dr. Elledge is on CDI’s scientific advisory panel and has
licensed CDI to market the commercial application of his research. Only CDI can provide this
service.
Service Provided:
CDI will accept human patient plasma samples from an IRB approved NIAAA clinical study.
They will process samples using their proprietary Virscan procedure which identifies every
virus annotated to have human tropism in the UniProt database. [https://cdi.bio/antygen-virscanphip-
seq-service/] This service includes: VirScan Analysis (>1000 individual strains across
206 unique viral species with known human tropism) of 240 serum samples, plus analysis of SARS-CoV-2 antibodies to S1 receptor binding spike & nucleocapsid proteins using CDI's SARS-CoV-2 Minichip. Combined assay (VirScan + SARS-CoV-2 minichip. Additionally, CDI will provide data for 20 serum samples on HuScan full human proteome assay for autoantibodies. Data will be sent to NIHs office for additional statistical analysis
The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under authority of the 41 U.S.C. 253(c) (1), FAR 6.302. Only one responsible source and no other supplies or services will satisfy agency requirements. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications – Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors – Commercial Items; FAR Clause 52.212-2, Evaluation – Commercial Items; FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items – Deviation for Simplified Acquisitions applies to this acquisition. NOTE TO CONTRACTOR: The contractor shall provide a completed copy of FAR 52.204-24, "Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment" with their quote in response to this solicitation. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.acquisition.gov/far/. Vendors capable of furnishing the government with the services and or items specified in this synopsis should submit a copy of their quotation/offer to the following email address: robinsti@mail.nih.gov Attn: Tina Robinson by the due date and time below. Offers must also be accompanied by descriptive literature, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements. Offeror must include the delivery date/timeframe with offer. Quotations will be due seven calendar days from the publication date of this synopsis before August 20, 2020 before 9:00 am EST. The quotation must reference “Solicitation number” NICHD-20-248 and “Solicitation number” NICHD-20-248 must be on/in subject line of email. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Any questions must be sent via email to robinsti@mail.nih.gov and must include Solicitation# NICHD-20-248 in the subject line of email.
Note: In order to receive an award, contractor must be registered as all awards and have valid certification in the System for Award Management (SAM) @ www.Sam.gov. Lack of valid registration in SAM will make an offeror ineligible for award.