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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 03, 2014 FBO #4635
DOCUMENT

A -- CLIA LABORATORY HUMAN TISSUE ANALYSIS - ONCOGENETICS GENOMICS ONCOLOGY RESEARCH VIA TARGET DNA SEQUENCE AND FROM GERM-LINE, CARCINOMA SPECIMEN, RNA TRANSCRIPTOME SEQUENCING OR WHOLE EXOME - Attachment

Notice Date

8/1/2014
 

Notice Type

Attachment
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of Veterans Affairs;NETWORK CONTRACTING OFFICE NEW ENGLAND;CONTRACTING EAGLE SQ UNCAS BLDG FL 3;623 ATWELLS AVENUE;Providence RI 02909-2472
 

ZIP Code

02909-2472
 

Solicitation Number

VA24114R0712
 

Response Due

9/16/2014
 

Archive Date

11/15/2014
 

Point of Contact

John Young
 

E-Mail Address

9-4760
 

Small Business Set-Aside

Total Small Business
 

Description

This is a Small Business pre-solicitation notice. This acquisition is one hundred percent (100%) set-aside for Small Business (SB) CLIA certified enterprises within NAICS 541711 (500 employees). An enterprise that is not a small business under NAICS code 541711 (500 employees) should not submit a response to the Request for Proposals. (RFP) Contracting Office Address: John Young John.young2@va.gov Network Contracting Office (New England) Uncas Bldg FL 3 - Eagle Square 623 Atwells Avenue Providence, RI 02909-2472 Note this Pre-Solicitation notice follows a Request for Information (RFI VA241-14-I-0352) that was released on April 3, 2014. (www.fbo.gov) Background The Department of Veterans Affairs (MAVERIC) has a requirement for Oncogenetics Genomics Oncology Research and Treatment via targeted DNA sequencing for known mutations and inference against known laboratory reference or from patient germ-line or carcinoma specimen sequencing RNA-transcriptome or from whole exome.The Department of Veterans Affairs, Veterans Health Administration requests information from the research laboratory CLIA-certified profit and non-profit small businesses. This Sources Sought Synopsis is based upon RFI VA241-14-I-0352, April 3, 2014 and the responses for a 100% small business set-aside for CLIA-certified small business vendors for this NAICS (541711 - 500 employees). CLIA laboratories who do not certify to this NAICS in www.sam.gov Representations and Certifications should not respond to any solicitation. Interested small business vendors may review the previously posted RFI, the attached White Paper and should monitor this web site for posting of the Request for Proposals. Statement of Issue: Advances in the treatment and management of patients with cancer will arise from precise phenotyping and detailed molecular characterization of VA patients and their specimens. The growing capability for detailed genomic analysis of tumor tissue provides vast improvements over current clinical testing models that are rapidly becoming inadequate and outdated. The Veterans Integrated Service Network 1 (VISN 1) has undertaken a program to support the collection and enhanced analysis of clinical and specimen-derived data on all patients seen at VA network hospitals who have a cancer diagnosis. The VA seeks to engage the small business CLIA laboratory contractor community with robust, scalable, dynamic, secure, innovative solutions of analyzing samples obtained during regular clinical care - such as tissues from biopsy - using new genomic assay technology. The Department seeks the CLIA vendor community to provide emerging technologies to improve oncology care for all patients within the VA healthcare system. The Department recognizes that there is a lack of consensus regarding which method of tumor mutation analysis is most practical, informative and cost-effective. The Department is particularly interested in the following methods: 1. Targeted sequencing of DNA fragments known to harbor mutations in cancer specimens (commonly referred to as a mutation panel). The number of DNA segments sequenced varies by the laboratory and assay performed. Mutations in the DNA can either be inferred against a laboratory 'reference' sequence or can be determined by sequencing of patient germ-line DNA obtained from adjacent normal tissue or peripheral blood. 2. Sequencing of the whole exome of cancer specimens, with mutations identified by comparison against a laboratory 'reference' sequence or germ-line DNA as described above. 3. Sequencing of the cancer specimen RNA or 'transcriptome'. This strategy can be combined with either targeted or whole exome DNA sequencing. The VA seeks CLIA enterprises with existing ability to perform enhanced target based oncology testing for veteran patients, including receipt and cataloging of all histopathologic specimens, pathology review to confirm the presence of cancer and determine tissue quality for testing, and extraction of and quality assessment of DNA and possibly RNA, with present capacity to implement recommended testing approaches among target or whole exome sequencing and use either of a laboratory reference or germ-line DNA as the comparator for variant calling and also performing whole transcriptome sequencing of tumor samples. Products of the testing returned to the VA include all sequence data including raw test data (FAST-Q, BAM, read quality files and variant call files) and a report of important mutations and their significance to be returned to the medical record. Mutations found in the tumor sample will be annotated so that clinicians can gain an understanding of their meaning. The laboratory shall specify how this annotation will be performed and in particular, what knowledge base will be used to generate the annotations. Due to the rapid evolution of knowledge generation in this field, a VA vendor must be able to demonstrate how the vendor maintains an up-to-date knowledge base and must be able to update annotations of a patient report upon request. Due to innovations, improvements and rapidly declining costs or tumor analysis, it is expected that the preferred testing technology will change over time. The White Paper referenced comprises the VHA MAVERIC Laboratory's notional concept for the problem of analysis of large data sets across a diverse patient demographic and oncogenes The contract tasking and requirements proper are set forth in the solicitation and resulting contract and the amendments and modifications thereto. The Department of Veterans Affairs underscores its interest both in new entrants to federal contracting and in the small business (SB) community who may have interest and present, immediate capacity and solutions in genomics. Interested contractors and vendors should monitor this web site (FBO) and Forecast of Opportunities (FCO) for VA requirements. A five (5) year Indefinite-Delivery Indefinite Quantity Fim Fixed Price Multiple Award Contract will be awarded to the successful offeror(s) under the Simplified Acquisition Procedures of Subpart 13.5-Test Program for Certain Commercial Items. The Government reserves the right to make multiple awards. Service Disabled and Veteran-Owned Small Businesses (SDVOSB and VOSB) contracting with VA are to be registered and certified by the Center for Veteran Enterprise (CVE) in Vatic if seeking consideration under PL 109-461 (www.vetbiz.gov - Vendor Information Pages - VIP) All contractors are required to be registered in the System for Award Management (www.sam.gov). Consult your State Procurement Technical Assistance Center (PTAC) for technical assistance with these requirements. (http://www.dla.mil/db/procurem.htm). Link to the VA Forecast of Contracting Opportunities: http://www.vendorportal.ecms.va.gov/eVP/fco/FCO.aspx POTENTIAL OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE RFP AND ALL AMENDMENTS. ALL INQUIRIES AND QUESTIONS SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACTING OFFICER (john.young2@va.gov) NO PHONE CALLS, NO FACSIMILE TRANSMISSIONS.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PrVMAC650/PrVAMC650/VA24114R0712/listing.html)
 

Document(s)

Attachment
 

File Name: VA241-14-R-0712 VA241-14-R-0712_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1543663&FileName=VA241-14-R-0712-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1543663&FileName=VA241-14-R-0712-000.docx

 

File Name: VA241-14-R-0712 VISN 1 Precision Oncology Program White Paper.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1543664&FileName=VA241-14-R-0712-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1543664&FileName=VA241-14-R-0712-001.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03446934-W 20140803/140801235022-81ee7f6064f727dd1e00919fd6eb79b3 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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