High frequency ultrasound for evaluation of skin disease

HHS-NIH-NCI-SS-TSB-0907-025

Title: High frequency ultrasound for evaluation of skin disease
Type of Notice:

This is a Supply Sources Sought/Presolicitation 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 capability of all qualified sources for the Supply requirement.

Background:

At the National Cancer Institute, we have a comprehensive, multidisciplinary group that
evaluates subjects with chronic graft-versus-host disease (cGVHD). Part of that evaluation
includes skin examination by dermatologists to characterize disease involvement, monitor
improvement or progression in therapeutic trials, and provide recommendations for treatment of
the skin disease. One of the most challenging components of the evaluation is that of skin
fibrosis . Fibrosis, or sclerosis, of the skin can be superficial or deep. Especially when deep,
palpation is not able to adequately assess the depth or extent of fibrosis. Magnetic resonance
imaging has been tested as a way to assess, but the sensitivity for dermal thickness is low. High
frequency ultrasound has been tested and used, both in clinical and in research environments, to
assess the thickness of the skin.

Purpose and Objectives:

This project seeks to measure thickness of the dermis in patients with fibrotic conditions,
primarily sclerotic cGVHD, but also other skin diseases with increased thickness. Measurements
will be used for diagnostic and monitoring purposes for subjects enrolled on protocols at NIH.

Project Requirements: (Specifications)

CORTEX TECHNOLOGY

DermaScan® USB technical specs and features 2012.
(Features of particular importance in bold)

Hardware:
Fully integrated lunchbox-sized design
One main unit for all probe frequencies
Laptop controlled via USB connection
Optional cradle with probe holder
200 MHz 12 bit A/D conversion
High system bandwidth, up to 100 MHz
Near real-time scanning up to 8 frames/sec. (scan time 0.125 s)
Automatic cineloop function captures last 100 images
Split screen function, four simultaneous images
20 MHz B-scanning at 60 x 150 micron resolution, 13 mm penetration (standard)
20 MHz B-scanning at 60 x 260 micron resolution, 23 mm penetration (optional)
50 MHz B-scanning at 30 x 60 micron resolution, 3mm penetration (optional)
Swept gain, full operator adjustment of both profile and level, amplification up to 42 dB
Built-in Ethernet and USB I/O connectivity
Unlimited HDD storage capacity with ext. HDD
Full color scale editor
RF-signal (optional)
Upgradeable to 3D scanning and 3D visualization

Probes:
Closed water chamber (no spillage)
12.1 mm scanlength at 20 MHz (2D)
6 mm scanlength at 50 MHz (2D)
22.4 x 22.4 mm scan area at 20 MHz (3D)
Counterbalanced movement, no vibration
Probes are precision calibrated acc. to focal distance

Software:
WINDOWS 7 operating system
DSCANV3 application software w. full-featured data analysis (ADVANCED config.)
Direct printing to any WINDOWS supported printer
Automatic timestamping of recordings
Autostore function
Patient data file and scan position marker
A/B-mode scan representation in 2D
Image formats: TIFF, JPG, DSC (internal)
A, B, C mode, surface and volume reconstruction in 3D, instant 3D visualization (3D option)
Export of measurements to spreadsheets
Zoom in/out and scroll function on live and "frozen" images
Automatic save/retrieve of scan settings

Extensive Measurement functions (ADVANCED config. only):
A-scan horizontal - current and average distance (+/- 1%)
A-scan vertical - current and average distance (+/- 1%)
Arbitrary distance (+/- 1%)
B-scan edge detection
B-scan min, max, average distance (+/- 1%)
B-scan line length calculation (+/- 1%)
B-scan intensity segmentation and area calculation (+/- 1%)
Region Of Interest calculation - automatic or manual (+/- 1%)
Volume and surface area (3D)
(Specifications may change without further notice)

Period of Performance:
Delivery one calendar year after award.

Capability Statement/Information Sought:
We encourage all responsible sources, particularly small businesses, to submit a capability statement which will be considered by the agency. Organizations that submit capability statements in response to this notice will be evaluated against the following criteria:
1. Documented ability to meet all specification in the statement of work including the coupled fiber capability.

Interested qualified organizations should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concern's name, point of contact, address and DUNS number.

All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Kelly J. Fowler, Contract Specialist, at Kelly.fowler@nih.gov in MS Word or Adobe Portable Document Format (PDF), by September 12, 2016, 12:00PM, EDT. All responses must be received by the specified due date and time in order to be considered. No collect calls or facsimile transmissions will be accepted.

Disclaimer and Important Notes:

Cyberderm Inc. in Media Pennsylvania is the only responsible source and no other supplies will satisfy agency requirements. Cyberderm, Inc. is the only vendor that offers these specifications of the equipment required.

The proposed contract action is for supplies for which the Government intends to solicit and negotiate with only one source, Cyberderm, Inc. in Media, Pennsylvania, under the authority of FAR 6.302. Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive proposals. However, all proposals received will be considered by the Government. A determination by the Government not to continue with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition.
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 pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

No proprietary, classified, 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.