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A -- Diagnosis and Monitoring of Alzheimer Disease (AD) in vivo using near-infrared Spectroscopy - NIR for Diagnosis of AD - Sources Sought

Notice Date
Notice Type
Sources Sought
541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
Contracting Office
Department of Veterans Affairs;VAMC Providence;MAILD STOP 90C - EAGLE 3;830 Chalkstone Avenue;Providence RI 02908
ZIP Code
Solicitation Number
Response Due
Archive Date
Point of Contact
John Young
E-Mail Address
Small Business Set-Aside
541 -- Professional, Scientific, and Technical Services/541712 -- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) PSC: AN12 Biomedical Applied Research and Exploratory Development Sources Sought Synopsis Diagnosing and Monitoring Alzheimer Disease (AD) in vivo using near-infrared (NIR) spectroscopy Contracting Office Address: VAMC Providence, Mailstop 650/90C, 623 Atwells Avenue, Providence, RI 02909-2472 This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: the availability and present capability of qualified sources to fulfill the Government requirement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Background The molecular bases of Alzheimer disease and related neuordegenerative disorders are becoming better understood, but the means for definitive diagnosis and monitoring in vivo remain lacking. Near-infrared optical spectroscopy (NIR) offers a potential solution. Transmission and reflectance spectra of thin brain tissue slabs have been used to calculate wavelength-dependent absorption and reduced scattering coefficients from 470-1000 nm. The reduced scattering coefficients in the near-infrared clearly differentiated Alzheimer Disease from control specimens. Diffuse reflectance spectra of gross brain tissue in vitro have confirmed this observation. These results suggest a means for diagnosing and monitoring Alzheimer disease in vivo using near-infrared optical spectroscopy. Introduction Alzheimer disease (AD) is a progressive, terminal, neurodegenerative disorder. The largest risk factor for AD is advanced age, and the public health impact of AD and related disorders is increasing in proportion to the senior population served by US Department of Veterans Affairs (VA). Purpose and Objectives The VA seeks solutions for the early diagnosis of AD and other neurodegenerative disorders by using non-invasive NIR in vivo to characterize the light-scattering signatures of dense protein aggregates. Interested contractors should consult the following paper for additional purpose and objectives: Reference: E.B Hanlon, L. T. Perelman, E. I. Vitkin, F. A. Greco, A. C. McKee, N. W. Kowall, Optics Letters 33, 624 (March 15, 2008) (Scattering Differentiates Alzheimer disease in vitro). The VA will assess the responses to this Sources Sought notice to determine the present existing ability and capacity in the contractor community to execute the tasks described in the requirements. Requirements The contractor shall design, fabricate and test near-infrared (NIR) optical spectroscopy technology for the non-invasive detection, diagnostic evaluation and monitoring of neurological disorders such as Alzheimer disease and related neurodegenerative disorders (AD), including mild traumatic brain injury (mTBI). The design, fabrication and testing shall be carried out in collaboration with and according to specifications developed by the US Department of Veterans Affairs. The technology provided shall be comprised of three distinct but mutually integral modalities/tasks: (1) hardware, a complete NIR spectrometer system for non-invasively acquiring near-infrared optical spectroscopic measurements, such as absorbance, fluorescence, reflectance, etc. of the human brain in vivo in a clinical setting. The contractor shall provide a multi-channel near-infrared (NIR) optical spectrometer system, which is compact, portable and suitable for clinical or bedside operations. (2) software, source code and executable files for (a) automated spectroscopic data acquisition, monitoring and control and (b) diagnostic algorithms based on spectroscopic data analysis; (3) testing of integrated technology (hardware and software), for safety, performance and specification compliance. In collaboration with Bedford VAMC, the contractor shall conduct both laboratory testing in house and at the Bedford, Massachusetts VA Medical Center (Bedford VAMC) as well as clinical testing at Bedford VAMC and/or participating clinical sites. The contractor s engineering team shall meet regularly with the VA Contracting Officer Technical Representative (COTR). The contractor shall document results of test and calibration procedures for review and approval by the COTR. Anticipated Period of Performance The anticipated period of performance is approximately eighteen to twenty four months from time of contract award. Capability Statement/Information Sought Your capability Statements should clearly convey information regarding your present capabilities to perform the modalities/tasks (1) (3), including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. You should submit a capability statement (five page limitation, excluding resumes) describing your company's experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Additional Information (1)Contractors are requested to provide a rough order of magnitude (ROM) estimate of the direct labor hours for each modality/task (1) (3) and rough time-line with milestones. (2)You should indicate which tasks you have the present ability to perform in-house and which tasks or subtasks which can be performed by your subcontractors. Any portion of the work that would require a subcontractor to perform should be identified, and the capability and experience of the subcontractor must be described. (3)All or part of any solicitation/contract may be subject to Information Security requirements, including requirements for safeguarding patient sensitive information, securing and destruction of storage media containing patient health information (PHI) as well as requirements for a contractor suitability determination. Indicate your capacity/ability to comply with VA and VHA privacy/security requirements set out inter alia in VHA Handbook 1200.6 (4)Indicate any other value-added features which your enterprise could bring to the VA, e.g., conduct of phase I clinical trials, complex Monte Carlo simulations, SEI CMM rating, adaptation and engineering of Commercial of-the-shelf (COTS) NIR apparatus to animal or human research, system integration ability, etc. (5)Each response should include the following Business Information: a. DUNS number and CAGE code b. Company Name and company structure (Corporation, LLC, partnership, joint venture etc.) c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Business size (Less than or greater than 500 employees?) (NAICS 541712) f. Type of Company (i.e., small business (SB), 8(a), woman owned (WOSB), veteran owned small business (VOSB), SDVOSB, etc.) as validated by both On-line Representations and Certifications (ORCA) (https://orca.bpn.gov/) and Central Contractor Registration (CCR). Government contractors are required to be registered in the CCR, located at http://www.ccr.gov/ SDVOSB and VOSB contractors are reminded to self-register and stay current in VetBiz (http://www.vip.vetbiz.gov ) if seeking contracting opportunities with the VA under the set-aside provisions of PL 109-461. Consult your State Procurement Technical Assistance Center (PTAC) for technical assistance with these items (http://www.dla.mil/db/procurem.htm) g. Universities and 501(c)(3) corporations should establish or seek a Cooperative Technology Administration Agreement (CTAA) (http://www.navref.org/library/CTAA_Guidance_to_NPCs.htm if seeking contract research opportunities with the VA. Indicate if your CTAA is established or in process. DUE DATE Responses must be submitted no later than 4:00 PM, August 5, 2010. Capability statements will not be returned. These statements may be submitted by e-mail (preferred method) or by paper copy (submit two copies if using paper) to John Young, Contract Specialist at the address below. Electronic submissions should be submitted in PDF or MS Word format to: john.young2@va.gov. Paper copies may be sent to the address provided below. No copies will be returned. Disclaimer and Important Notes Information exchanged arising from this synopsis is market research information within the meaning of FAR 10.0 and 15.201. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: John.young2@va.gov VAMC Providence Mailstop 650/90C 623 Atwells Avenue 3rd Floor Providence, RI 02909-2472 401-459-4760 x 1588 Confidentiality No proprietary, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
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