MODIFICATION
Q -- Services to support the research entitled Circulating Tumor Cells (CTCs): A potential screening test for clinically undetectable breast carcinoma through the enumeration and phenotyping of CTCs
- Notice Date
- 8/23/2010
- Notice Type
- Modification/Amendment
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- RDECOM Contracting Center, Natick Base Ops (RDECOM-CC), Directorate of Contracting, Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- N0016810MP14003
- Response Due
- 8/26/2010
- Archive Date
- 10/25/2010
- Point of Contact
- Christine Sordillo, 508-233-4126
- E-Mail Address
-
RDECOM Contracting Center, Natick Base Ops (RDECOM-CC)
(christine.sordillo@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Solicitation Number: N0016810MP14003 Notice Type: Combined Synopsis/Solicitation Synopsis: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (i) INTRODUCTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 in combination with Subpart 13.5, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) SOLICITATION TYPE This solicitation, numbered N0016810MP14003, is issued as a Request for Proposal (RFP). (iii) CURRENTNESS The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-37. (iv) SET ASIDE None, this is an unrestricted acquisition. (v) REQUIRED ITEMS The government requires the following items: The mission of the National Naval Medical Center (NNMC) is to prepare to deploy in support of operational forces, to deliver quality health services, and to shape the future of military through education, training, and research. NNMC believes that its staff is its most important resource, its patients are its focus, and its success is judged by those it serves. In order to optimize the performance in support of accomplishing its mission, the NNMC Pathology Research Program requires services to support the research entitled Circulating Tumor Cells (CTCs): A potential screening test for clinically undetectable breast carcinoma through the enumeration and phenotyping of CTCs. The following procedures are required for this effort: 1.General CTC enumeration a.The blood samples should be procured in proper blood collection tubes and shipped at room temperature to contractors facility. b.The blood should be subjected to a common, red blood cell lysis step. c.The blood samples should be labeled with a magnetic reagent which only targets normal blood cells (CD45+) d.The blood sample should be passed through a very high field magnetic separator using a patented process. e.The cell exiting the magnetic sorter are highly enriched for unsual and rarely occurring cells, including CTC. 2.After performing the above mentioned enrichment processing, the enriched blood samples must be processed (if CTCs are identified) by making multiple aliquots; a) one aliquot for cell rupture and preserving for future molecular analysis, b) formalin fixing an aliquot of whole cells for future analysis, and c) making cytospins for ICC analysis. a.Contractor should apply staining protocols (four parameter) analysis of the cytospins of the cells for presence of: a) nuclei, b) cytokeratins, c) and d) markers of interest b.Contractor should analyze these stained cells with and/or: a) fluorescence microscopy, b) Confocal microscopy, or c) fluorescence and spectral deconvolution using Nuance technology. c.Results and all of the preserved aliquots should be returned back to NNMC for specimen banking. Period of Performance: Performance shall be for a period of up to three years. Security Clearance: Performance of this SOW does not require access and does not authorize access to classified information. NAICS Code: 622110 General Medical and Surgical Hospitals, $34.5M. Government Furnished Facilities & Government Furnished Information: Contractor employees will work off-site at the contractors facility. ADDITIONAL INFORMATION: According to market research, legacy expertise for CTC enumeration and processing has traditionally resided at Ohio State University. The following suggestions have been provided to help guide the offeror in constructing their proposal. Enrichment and detection of CTCs from peripheral blood of cancer patients The blood samples should be procured in Streck Cyto-Chex BCT tubes (Streck Inc., Cat# 213362) or Streck Cell-Free DNA BCT tubes (Streck Inc., Cat# 218961). The samples should be shipped at room temperature through express mail preferably. Once received, the samples at contractors facility, samples should be processed immediately according to the following protocol. Enrichment protocol: Each blood sample should be diluted with 1X red cell lysis buffer at a ratio of 1:25, incubated for 5 min at RT, spun at 350g for 5 min to pellet the PBLs. The cell pellet should be washed with buffer containing BSA and EDTA, resuspended in buffer and the PBL count estimated before immunomagnetic labeling. Based on the PBL count in the blood sample, anti-CD45 tetrameric antibody complex (TAC) will be added (0.5L per 106 cells) and the cells incubated at RT for 30 min with frequent vortexing. Without washing the cells, magnetic nanoparticles should be added to the cell suspension (1L per 106 cells) and incubated for 15 min at RT. The immumagnetically labeled cell suspension will subsequently be run through the deposition QMS (Quadrupole Magnetic Sorter) system and the enriched sample will be collected at the channel outlet. The enriched sample should be stored as a suspension in 10% neutral buffered formalin until IF staining. Detection protocol: Contractor should have protocols in place to stain for three different markers (transmembrane or cytoplasmic) in addition to nuclear staining using DAPI. The immunofluorescently labeled cells should be imaged using Olympus FluoView1000 spectral Viewer or Nuance Camera mounted on Nikon Eclipse 80i. The following is a protocol to stain for cytokeratins, vimentin, EGFR and DAPI. Aliquots of the stored samples are cytospun onto a microscopic slide at 1500 rpm for 5 min and air dried. After hydrating the samples in PBS for 5min, the cells should be permeabilized with 0.1% Triton X-100 in PBS for 15 min at RT and washed in PBS. The cells should then be blocked using 1% BSA in PBS or other specific blocking agent for 1 hr at RT. Following the blocking step, the cells should be incubated with mouse anti-vimentin (AbCam, Cat#ab20346, 1:200) and rabbit anti-EGFR (Abcam, Cat#ab2430, 1:200) for 1 hr at RT. After washing the slides in PBS (3x5min), the cells should be incubated with anti-mouse AlexaFluor 555 IgG (1:400) and anti-rabbit AlexaFluor 633 IgG (1:200) secondary antibodies for 1 hr at RT. The slides should be washed in PBS and then incubated with pan anti-cytokeratin antibody (Miltenyi Biotech, Cat#130-080-101, 1:10) for 30 min at 37 C. After washing the slides in PBS (3x5min), the slides should be blotted dry and mounted with DAPI containing mounting media (Vector Laboratories, Cat#H-1500). Other markers that we can look at are N-cadherin, CD44 and g-H2AX. Additionally, offerors can refer to the following publications for further clarification as the suggested best practice methods for the proposed CTC enumeration: -Yang, L., Lang, J.C., Balasubramanian, P., Jantan, K.R., Schuller, D., Agrawal, A., Zborowski, M., Chalmers, J.J. Optimization of an Enrichment process for Circulating tumor cells from the blood of Head and Neck Cancer patients through depletion of normal cells. Biotechnol. Bioeng. 102 (2):521-534. 2009. PMID: 18726961 -Balasubramanian, P., Yang, L., Lang, J.C., Jatana, K.R., Schuller, D., Agrawal, A., Zborowski, M., Chalmers, J.J. Confocal images of circulating tumor cells obtained using a methodology and technology that removes normal cells. Molecular Pharmaceutics 6(5):1402-1408, 2009. PMID: 19445481 (vii) PROPOSAL INSTRUCTIONS The provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and is incorporated by reference into this RFP. (viii) EVALUATION OF PROPOSALS The provision at 52.212-2, Evaluation -- Commercial Items, applies to this acquisition and is incorporated by reference into this RFP. Proposals will be evaluated on the following factors: Compliance with Government requirements, technical knowledge, past performance, and cost reasonableness. The factors are listed in descending order of importance, and the non-price factors, when combined, are significantly more important than price. The Government intends to use a trade off process to determine which quote offers the best value; therefore, Vendors are cautioned that a contract may not necessarily be made to the lowest priced quote. (x) REPS & CERTS Vendors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with their proposals. (xi) STANDARD TERMS & CONDITIONS The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and is incorporated by reference into this RFP. (xii) STANDARD TERMS & CONDITIONS The clause at 52.212-5 DEVIATION, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items DEVIATION, applies to this acquisition and is incorporated by reference into this solicitation. (xiii) ADDITIONAL TERMS & CONDITIONS The following FAR and DFARS clauses apply to this acquisition and are incorporated by reference: 52.203-3 Gratuities APR 1984 52.203-6 Alt I Restrictions On Subcontractor Sales To The Government (Sep 2006) -- Alternate I OCT 1995 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards JUL 2010 52.212-4 Contract Terms and Conditions--Commercial Items OCT 2008 52.212-5 Contract Terms And Conditions Required To Implement Statutes Or Executive Orders--Commercial Items (Dec 2008) (Deviation) 52.222-26 Equal Opportunity MAR 2007 52.222-35 Equal Opportunity For Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans SEP 2006 52.222-36 Affirmative Action For Workers With Disabilities JUN 1998 52.222-37 Employment Reports On Special Disabled Veterans, Veterans Of The Vietnam Era, and Other Eligible Veterans SEP 2006 52.222-39 Notification of Employee Rights Concerning Payment of Union Dues or Fees DEC 2004 52.222-50 Combating Trafficking in Persons AUG 2007 52.222-54 Employment Eligibility Verification SEP 200952.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.227-1 Authorization and Consent DEC 2007 52.227-2 Notice And Assistance Regarding Patent And Copyright Infringement DEC 2007 52.229-4 Federal, State, And Local Taxes (State and Local Adjustments) APR 2003 52.232-33 Payment by Electronic Funds Transfer--Central Contractor Registration OCT 2003 52.233-3 Protest After Award AUG 1996 52.242-13 Bankruptcy JUL 1995 52.247-34 F.O.B. Destination NOV 1991 52.253-1 Computer Generated Forms JAN 1991 252.203-7000 Requirements Relating to Compensation of Former DoD Officials JAN 2009 252.203-7002 Requirement to Inform Employees of Whistleblower Rights JAN 2009 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7004 Alt A Central Contractor Registration (52.204-7) Alternate A SEP 2007 252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Terrorist Country DEC 2006 252.212-7001 Contract Terms And Conditions Required To Implement Statutes Or Executive Orders Applicable To Defense Acquisitions Of Commercial Items (Jan 2009) (Deviation) 252.225-7001 Buy American Act And Balance Of Payments Program JAN 2009 252.225-7002 Qualifying Country Sources As Subcontractors APR 2003 252.225-7012 Preference For Certain Domestic Commodities DEC 2008 252.225-7013 Duty-Free Entry OCT 2006 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports MAR 2008 252.232-7010 Levies on Contract Payments DEC 2006 252.235-7002 Animal Welfare DEC 1991 252.235-7004 Protection of Human Subjects JUL 2009 252.239-7001 Information Assurance Contractor Training and Certification JAN 2008 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment MAR 1998 252.246-7000 Material Inspection And Receiving Report MAR 2008 52.252-2 Clauses Incorporated By Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): Http://farsite.hill.af.mil/farsite_alt.html (xiv) SUBMISSION OF PROPOSALS Proposals shall be submitted electronically to Christine Sordillo via christine.sordillo@us.army.mil. All proposals shall be submitted before 4pm Eastern time on 26 August 2010. **Proposals will only be accepted via electronic submission to the email address listed above. (xv) QUESTIONS Questions regarding this acquisition may contact the contract specialist, Christine Sordillo, at the above listed email address. Additional Info: US Army RDECOM CC Natick Contracting Division Contracting Office Address: RDECOM Contracting Center - Natick R&D (RDECOM-CC), ATTN: CCRD-NA-SY, Natick Contracting Division Building 1, Kansas Street, Natick, MA 01760-5011 Place of Performance: National Naval Medical Center 8901 Wisconsin Avenue, Bldg.1, Room 4397 Bethesda, Md 20889 US Point of Contact(s): Christine Sordillo, christine.sordillo@us.army.mil
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FBO.gov Permalink
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- Place of Performance
- Address: RDECOM Contracting Center, Natick Base Ops (RDECOM-CC) Directorate of Contracting, Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN02250985-W 20100825/100823235051-578bdd266280336d80660808b96a93fd (fbodaily.com)
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