OraSure Antibody and Testkit SOW_Amendment 1.pdf

Biomedical Advanced Research and Development Authority (BARDA)

Division of Detection, Diagnostics, & Devices Infrastructure (DDDI)

Filovirus Point-of-Care (PoC) Diagnostic Tests

Statement of Work

BACKGROUND:

On April 23, 2022, the Ministry of Health in the Democratic Republic of the Congo declared an outbreak of Ebola virus disease (EVD) in Mbandaka health zone, Equateur Province. This is the 14th EVD outbreak in DRC and marks the third in a series of outbreaks in Equateur province since 2018.

OBJECTIVE:

The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and

Human Services (HHS) seeks to purchase diagnostic tests for Ebola virus. The test must be a point of care, handheld, lateral flow, rapid antigen test for Ebola virus that is either emergency use authorized or

510(k) cleared by the U.S. Food and Drug Administration. The test sample type must be oral fluid from cadavers. The test must be for use on individuals suspected to have recently died from the Ebola virus disease.

OraSure Technologies is uniquely qualified because their product is the only test that meets all the following salient characteristics:

• For point of care use

• Handheld

• Lateral flow, rapid antigen test for Ebola virus

• Either emergency use authorized, or Section 510(k) cleared by the U.S. Food and Drug

Administration (FDA)

• Samples oral fluid from cadavers

• For use on individuals or suspected to have recently died from the Ebola virus disease

• Nine (9) month shelf life from date of production

Alternative tests will not work because the Government will be unable to assess infection with the Ebola

Virus in individuals and cadavers. The inability to assess infections would jeopardize HHS’ public health mission in a way that would result in unacceptable risks to the health of the public.

SCOPE OF WORK:

Per FDA requirements, approved test kits can only be manufactured with the reagents used to obtain

FDA clearance. Additional polyclonal Goat Source Anti-Ebola (Zaire) VP40 Antibody is required before manufacturing of the required ebola test kits can commence.

Therefore, the contractor shall:

1. Purchase Goat Source Anti-Ebola (Zaire) VP40 Antibody on behalf of the Government. The

Government shall retain ownership of the reagent for the duration of the contract.

2. Maintain Goat Source Anti-Ebola (Zaire) VP40 Antibody at their facility for a period of no less than 60 months, is completely used, or it repeatedly fails quality studies in accordance with the contractor’s quality standard which includes storage at -50˚C in a freezer with electronic temperature and power monitoring.

3. Reserve polyclonal goat anti-VP40 antibody (Ebola virus Zaire) for the exclusive use of BARDA.

4. Obtain written permission from the Contracting Officer or Contracting Officer’s Representative prior to using the reagent to manufacture any lots, including testing lots.

5. Upon the exercise of the option, manufacture Ebola virus test kits and ship the kits to the delivery location specified in this document.

DELIVERABLES:

Deliverable Quantity UOM Due Date Delivery Location

Goat Source Anti-Ebola (Zaire) VP40 Antibody

100 MG 60 days After Receipt of Order (ARO)

220 E. 1st Street Bethlehem, PA 18015

Monthly Status Report

The contractor shall provide a written status report including the following elements:

• Amount of reagent used and remaining

• Any irregularities in reagent storage

• Number of inquiries received for the use of the reagent

• Status report and data from each study undertaken in root cause analysis

• Additional information as requested by the COR

12 MO By the 5th day of each month

Email to COR

Closeout Report:

Summary report of each study performed using the reagent, analyzed data and conclusions from each study, how much antibody remains in stock, and any irregularities in reagent storage conditions.

1 YR By the 5th day of the final month of the contract

Email to COR

OPTIONAL

Goat Source Anti-Ebola (Zaire) VP40 Antibody

Up to

MG 60 days After Receipt of Order (ARO)

220 E. 1st Street Bethlehem, PA 18015

Monthly Status Report

The contractor shall provide a written status report including the following elements:

• Amount of reagent used and remaining

• Any irregularities in reagent storage

• Number of inquiries received for the use of the reagent

• Status report and data from each study undertaken in root cause analysis

Additional information as requested by the COR

12 MO By the 5th day of each month

Email to COR

Closeout Report:

Summary report of each study performed using the reagent, analyzed data and conclusions from each study, how much antibody remains in stock, and any irregularities in reagent storage conditions.

1 YR By the 5th day of the final month of the contract

Email to COR

OraQuick Rapid Antigen Test* 8500 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Visual Reference Panel

100 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Rapid Antigen Oral Fluid Test Kit Controls

120 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Rapid Antigen Test* 8500 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Visual Reference Panel

100 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Rapid Antigen Oral Fluid Test Kit Controls

120 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Rapid Antigen Test* 8500 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Visual Reference Panel

100 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Rapid Antigen Oral Fluid Test Kit Controls

120 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Rapid Antigen Test* 8500 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Visual Reference Panel

100 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Rapid Antigen Oral Fluid Test Kit Controls

120 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Rapid Antigen Test* 8500 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Visual Reference Panel

100 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

OraQuick Ebola Rapid Antigen Oral Fluid Test Kit Controls

120 EA 90 days After Receipt of Order (ARO)

CDC, Special Pathogens Branch 1600 Clifton Road Atlanta, GA 30333

*Should Government-owned reagent be used to produce these test kits, the contractor’s price per kit shall be reduced by _% or $X.XX per test.