The National Cancer Institute (NCI), Division of Cancer Treatment
and Diagnosis (DCTD), Cancer Diagnosis Program plans to procure on a sole
source basis with Kaiser Permanente, Washington University School of Medicine,
Fox Chase Cancer Center, and the University of Miami for Specimen Preparation
for Construction of
Well-Annotated Progression and Prognostic Tissue Microarrays (TMAs) for Invasive Breast Carcinoma for Use in
Breast Cancer Research.

The services herein are being procured in accordance with
the simplified acquisition procedures authorized by FAR Part 13.106-1 (b) (1).
The North American Industry Classification System Code is 541712 the business
size standard is $7 M.

The Cancer Diagnosis Program (CDP) has overall
responsibility for planning, evaluation and coordination of NCI research and
biospecimen resources related to cancer diagnostics. The Cooperative Breast Cancer Tissue Resource
(CBCTR) was started in 1993 to provide breast cancer tissue specimens and
accompanied long-term clinical follow up data to the breast cancer research
community. It represents a model
specimen biorepository which successfully supports a large variety of
studies by a growing number of breast
cancer investigators and is uniquely positioned to impact breast cancer research
as well as the diagnosis, treatment and survival of thousands of breast cancer
patients.

The period of performance for this procurement will
be 12 months from date of award.

Contractor
Requirements:

The contractors must have access to a large number of well
annotated invasive breast carcinoma pathology cases from a representative
patient population from diverse geographic areas with 5-10 years of clinical
follow data are needed for designing prognostic and progression TMAs with built
in statistical significance. Clinical
and outcome data fields associated with each case (patient) include:
histological diagnosis, demographic data, extent of disease, treatment,
follow-up, recurrence, survival and vital status.

Each TMA requires several hundred breast cancer cases. Board
certified pathologists need to select pathology blocks, cut slides from the
blocks, perform QA/QC and identify of diagnostic areas of interest on the
slides for coring and construction of the TMAs. QA/QC needs to be also
performed to correlate statistical and clinical data used in the TMAs.

Tissue specimens with
well documented clinical follow up are required for the development and
validation of diagnostic assays before they can be evaluated for their clinical
utility in prospective clinical trials. The CBCTR is a collection of over 9,000 cases of archival breast cancer
tissue with clinical and outcome data which is housed in four institutions:
Washington University, St. Louis, MO; Fox Chase Cancer Center,
Philadelphia, PA; University
of Miami, FL and Kaiser
Permanente, Portland, OR. It provides a critical and comprehensive
collection of breast cancer tissue specimens and tissue miscoarrays (TMAs) for
many academic and industry breast cancer researchers who are developing and
validating biomarkers for prognosis and classification of breast cancer. No other readily available resource exists in
the US
that can provide access to such large numbers of specimens with high quality
patient and outcome data developed using standardized data elements. Clinical
and outcome data associated with each case (patient) include: histological
diagnosis, demographic data, extent of disease, treatment, follow-up,
recurrence, survival and vital status. Non-involved adjacent breast tissue is available for many of the
cases.

This is not a request for competitive quotation.
However, if any interested party believes it can meet the above requirement, it
may submit a statement of capabilities. The statement of capabilities and any
other information furnished must be in writing and must contain material in
sufficient detail to allow the researcher to determine if the party can meet
this requirement. One (1) original and one (1) copy of the capability statement
must be received in the contracting office by 1:00 p.m. ET on September 22,
2008. All questions must be in writing and can be faxed to 301-402-4513 or sent
via email to Melissa Marino: marinome@mail.nih.gov It is the vendor’s responsibility to ensure questions have been received. 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. No collect calls will
be accepted. In order to receive an award, contractor must have valid, updated
registration and certification in the Central Contractor Registration (CCR) and
the Online Representations and Certifications Application (ORCA). Please
reference NCI-80226-MM on all correspondence.