The
National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics
(DCEG), Genetic Epidemiology Branch (GEB) plans
to procure on a sole source basis services in support of Human Papilomavirus
prevalence in Lung Cancer Tumors from Johns Hopkins University, Departments of
Oncology & Epidemiology; 1650 Orleans Street, CRB G91 Baltimore, MD 21231.

This acquisition will be processed in accordance with
simplified acquisition procedures as stated in FAR Part 13.106-1 (b)(1). The
North American Industry Classification System code is 541712 the business size
standard is $7 million.

The purpose of this contract is to determine the prevalence
and functionality of HPV in lung cancer fixed tissue specimens. This data will
aid the The Genetic Epidemiology Branch (GEB) in
the execution of a case series study of lung cancer in EAGLE. Understanding if
HPV plays a role in lung cancer could have important public health
implications.

The Genetic Epidemiology Branch
(GEB) conducts intramural research in the areas of genetics (human and
infectious) and cancer, as well as cancer and prevention. The GEB ,DCEG, NCI is currently examining the
hypothesis that human papillomavirus (HPV) is involved in lung cancer. To
estimate the prevalence of HPV infections in lung cancer cases from GEB’s Environmental
And Genetic Lung cancer Etiology (EAGLE) study, the contractor shall provide
services for measurement of HPV DNA in paraffin-embedded tissue. The DNA
detection methods must be sensitive and specific for the detection of a broad
range of HPV types, and in particular for HPV16, which causes most
HPV-associated cancers, and in situ hybridization must be used to confirm the
presence of the virus in the tumor cells as only this approach provides localizing
spatial information that may support etiologic involvement of HPV. Information
on HPV integration and HPV oncogene expression shall also be provided as an
indication of the functionality of any HPV detected.

The period of performance shall be one year from date of
award.

The vendor shall:

1. Test 450
paraffin-embedded lung tumor tissues for a range of carcinogenic and
non-carcinogenic HPV types using PCR with PGMY primers.

2. Test 450
paraffin-embedded lung tumor tissues for HPV16 using PCR with type-specific
primers for the E6 region.

3. Confirm the presence
of HPV in any PCR-positive samples (based on studies performed under No. 1 and
No.2) using in situ hybridization (ISH) and evaluate HPV integration based on
the ISH staining pattern.

4. Test for HPV oncogene
expression, as measured by p16-overexpression, in all HPV DNA-positive cases
(defined by positivity in No. 1 and No. 2) and an age-smoking-gender matched
set of HPV-negative cases.

5. Provide regular updates
at EAGLE meetings, data for manuscripts, talks, and discussions with the EAGLE
collaborators.

Services shall be
provided by Johns
Hopkins University
departments of Oncology and Epidemiology and the laboratory of Dr. Maura
Gillison. Dr. Gillison was trained in the laboratory that developed the
PGMY09/11 system, a sensitive and specific method to detect a wide range of HPV
types. This system is preferable to other PCR assays because it has increased
ability to detect specific HPV types, particularly when multiple infections are
present, in comparison to other HPV DNA detection methods. The laboratory has experience
with lung cancer, as well as cervical and other non-cervical HPV-associated
cancers. The work has established Dr. Gillison’s credibility in HPV detection
among the HPV experts. Credibility is essential to the success of this project
given that many HPV experts simply do not believe study results that have
reported high HPV prevalences in lung tumors.

Johns Hopkins
Laboratory has the necessary equipment to perform all of the assays required: PCR
tests for both a broad range of HPV types using PGMY primers and for HPV16 E6 DNA, which is a key step given concerns that disruptions or deletions in the L1 region may
lead to false-negative results from L1-based primers; in situ
hybridization, and p16-over expression. The JH Laboratory allows completion of
all testing in a single, established, credible laboratory. It is critical to
contract with one laboratory in order to maximize efficiency, avoid potential
errors involved in splitting/combining data and specimens, establish
consistent, uniform quality control for all assays, and make the best use of
the strictly limited number and irreplaceable nature of the available tissue
specimens, as well as to minimize the potential for contamination.

The Johns Hopkins
Laboratory is the only known laboratory that can verify PGMY and E6 PCR-positive assays with in situ
hybridization and has also had experience in processing and testing paraffin-embedded
head and neck specimens for HPV. The HPV DNA purification method is critical
for HPV detection in head and neck specimens, and may influence HPV detection in lung
cancer specimens as well.

This is not a solicitation for competitive quotations. However, if any interested party believes
they can meet the above requirement, they may submit a statement of
capabilities. All information furnished shall be in writing and
must contain sufficient detail to allow the NCI to determine if it can meet the
above unique specifications described herein. An original and one copy of
the capability statement must be received in the NCI contracting office by 11:00
AM ET on August 29, 2008. All questions must be in writing and can
be faxed (301) 402-4513 or emailed to Karri Mares, Contract Specialist at maresk@mail.nih.gov. A determination by the Government not to
compete this proposed contract 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
have valid registration and certification in the Central Contractor
Registration (CCR) www.ccr.gov and the Online
Representations and Certifications Applications (ORCA),
http://orca.bpn.gov. No collect calls will be
accepted. Please reference NCI-80188-KM on all
correspondence.