[ascct] SBIR opportunity

  • From: Kristie Sullivan <KSullivan@xxxxxxxx>
  • To: "ascct@xxxxxxxxxxxxx" <ascct@xxxxxxxxxxxxx>
  • Date: Sat, 19 May 2012 00:39:30 -0400

Members:

Please see below for a DOD funding opportunity. The National Academies report 
Toxicity Testing in the 21st Century: A Vision and Strategy suggested that the 
development of biomarkers, in order to monitor population exposures and 
discover toxicity pathways, is an important piece of moving to a new testing 
paradigm. This I thought the opportunity relevant.

_______________________________

Minimally Invasive, Self-Collection of Large Volume Biospecimens

More information about the solicitation can be found at 
http://www.dodsbir.net/Topics/Default.asp and searching for Topic SB122-003 
(the text is also pasted below).



SB122-003 TITLE: Minimally Invasive, Self-Collection of Large Volume 
Biospecimens

TECHNOLOGY AREAS: Biomedical

OBJECTIVE: Develop advanced technologies that can be self-operated by a patient 
or a minimally trained operator to collect large volumes/weights of a 
biospecimen for clinical use, such as diagnostic and remote clinical trials, or 
for research applications such as biomarker discovery/validation.

The majority of diagnostic tests and research assays require blood biospecimens 
that are traditionally collected using phlebotomy techniques performed by 
trained personnel. In limited resource areas, such as DoD deployment locations, 
remote or impoverished geographic areas, or emergency response locations, 
absence of blood sample collection by a trained phlebotomist can be a 
significant limitation to clinical care. Lancet or finger stick blood 
collection methods are one solution to minimize the need for these resources 
but suffer from low biofluid volumes that statistically may not contain the 
biomarker(s) of interest at the concentrations necessary for detection or 
clinical correlation. See reference #1 for examples of proteins in blood. 
Solutions are sought that enable the simple self-collection of sufficient 
biospecimen volumes or weights for the detection of low abundance diagnostic 
biomarkers. All biospecimens are of interest and include blood, sweat, tears, 
etc. Technologies developed should be minimally invasive, simple to operate, 
and allow for remote self-collection of a sufficient sample volume (e.g. >100 
microliters for blood) or weight, to allow for detection of a low-abundance 
panel of biomarkers at a reference laboratory or point-of-care setting. 
Potential users include minimally trained individuals and medics in settings 
where phlebotomy is not available.

If the technology is successfully developed, the capability to statistically 
capture low abundance biomarkers by increasing the amount of biospecimen 
collected in low resourced settings is anticipated to widely improve clinical 
care and biomedical research by enabling remote clinical trials, distributed 
remote access diagnostics, public health surveillance and biomarker research.

DESCRIPTION: There is the need for technologies capable of collecting patient 
biospecimens at sufficient volumes or weights, in a manner that allows for 
statistically relevant clinical guidance after the sample has been processed 
and analyzed. At the same time, enabling the capability to self-collect a 
biospecimen could provide a means to more confidently diagnose or track disease 
at its earliest stages, provide an ability to better expand clinical trials 
into remote settings, and increase the diversity of population cohorts needed 
for biomarker research. For example, blood biospecimens are the biofluid of 
choice for most diagnostic applications but require trained phlebotomists to 
collect and process. Simultaneously, there has been a push towards the 
miniaturization of detection technologies (eg. “lab-on-a-chip” and “nano-bio” 
technologies), but there has been a disconnect between sample acquisition and 
downstream analysis in a manner that allows for the detection of low abundance 
analytes.

Aggressive low volume scaling through finger-stick or lancet components affords 
clear advantages for sample preparation, reagent usage, thermal load, 
manipulation, and reaction kinetics, but there is nevertheless the challenge of 
dealing with “the law of small numbers”, or Poisson’s Distribution, which 
indicates that for small biospecimen volumes there may be no targets available 
for amplification or detection. In other words, diagnostic instruments may be 
developed that are small, portable, and require only a few drops of blood, but 
if the target analyte is not present in the small volume, the test could be 
susceptible to false negatives or not provide sufficient statistical confidence 
to provide clinical guidance.

Additionally, biospecimens other than blood, such as sweat, interstitial 
fluids, or tears may have the potential to be a powerful natural repository of 
clinically relevant biomarkers but there lack the technologies for 
self-collection and concentration. Technologies that offer the simplicity of a 
finger stick device (as an example) with the capability to collect larger 
biospecimen volumes or weights would overcome a diagnostic hurdle that limits 
widespread diagnostic testing outside of traditional clinical settings such as 
a clinic or hospital. Therefore, proposals are sought that address large volume 
(eg. >100 microliters for blood) or weight biospecimen collection via a device 
that is simple to operate and minimally invasive. The design should consider 
minimally trained individuals and medics as potential users. Proposers are 
encouraged to consider methods and technologies compatible with clinical 
workflows, good laboratory practices (GLP), and good manufacturing practice 
(GMP) procedures.

PHASE I: Demonstrate feasibility of methods or technologies for large volume or 
weight collection. Proposers must address both the volume/weight of biospecimen 
collected, as well as address how device operation is conducted under 
conditions of minimal invasiveness and ease-of-use. Proposers should aim to 
collect as large a volume or weight as possible (eg. at least 100 microliters 
for blood) while retaining the capability for operation by a minimally trained 
user.

Collection devices may be designed to hold the collected biospecimen within the 
device or to dispense the biospecimen into an instrument or alternate storage 
device. Proposers should demonstrate initial designs and collection 
volumes/weights, and project Phase II collection volume/weight capabilities.

Proposals that demonstrate universal compatibility for downstream analysis 
under a wide dynamic range of analytes are preferred. Of interest are 
quantitative metrics measured with a variety of protein, nucleic acid, 
metabolic and/or other analytes relevant to human biology. Phase I efforts 
should justify the applicability to settings such as home use, and 
consideration of FDA regulations is encouraged.

PHASE II: Phase II efforts should quantify collected biospecimen volume/weight 
and address reproducibility of the collection volume/weight with different 
prototypes under similar and different conditions. Detection of a panel of 
well-characterized, low abundance biomarkers should be demonstrated from 
collected samples using standard laboratory practices. Of interest are 
quantitative metrics measured with a variety of protein, nucleic acid, 
metabolite and/or other analytes relevant to human biology.

Phase II efforts should evaluate the device effectiveness and reproducibility 
when operated by untrained users. Additional interests include demonstrations 
that the proposed technology is developed to include 
standardization/normalization of the biospecimen to reference analyte 
concentrations across collections, with sensitivities that can address sample 
variability.

Manufacturing designs and costs should be considered for all components of the 
device. Compatibility of the collection device with downstream biospecimen 
storage devices and/or analysis technologies should be considered. Device 
potential for FDA clearance as a blood collection device for home use or 
physician office settings should be described.

PHASE III: The technology to be developed should enable blood collection 
outside of a major clinical facility and therefore could have significant 
impact on the clinical diagnostic market. There is a significant commercial 
market for medical diagnostics and home-use physician-office based diagnostic 
testing is a growing element of this market. The developed technology would 
potentially allow collection of sufficient sample in such settings, as well as 
enable clinically valid diagnostic testing and biomarker research. Potential 
commercial partnerships/customers include major diagnostics companies and life 
sciences research technology companies.

The technology to be developed is critical for DoD, as many medics have minimal 
training. Development of a FDA-approved collection device could enable use of 
newly developed diagnostic tests in remote/deployment settings as well as 
expand the military capabilities to perform more effective clinical trials of 
new therapeutics and diagnostics in remote settings or expand capabilities to 
detect and track emerging disease. Potential transition customers include 
Center for Disease Control and Prevention, Air Force Surgeon General, Military 
Health System - Defense Medical Research and Development Program (MHS DMRDP), 
Military Infectious Diseases Research Program (MIDRP), and the commercial 
sector.

REFERENCES:

1. Anderson N.L., Anderson N.G., Mol Cell Proteomics, 2003,2,50.

2. CLIA:http://wwwn.cdc.gov/clia/regs/toc.aspx

3. A. Manz, N. Graber, and H.M. Widmer, Miniaturized Total Chemical Analysis 
Systems: A Novel Concept for Chemical Sensing, Sensors and Actuators, 1990, B1, 
(1 – 6), 244 – 248

4. Kurt E. Petersen, William A. McMillan, Gregory T. A. Kovacs, M. Allen 
Northrup, Lee A. Christel and Farzad Pourahmadi, “Toward Next Generation 
Clinical Diagnostic Instruments: Scaling and New Processing Paradigms,” 
Biomedical Microdevices, 1998, Vol 1 (1), 71-79.

5. Raymond Mariella Jr., “Sample preparation: the weak link in 
microfluidics-based biodetection,” Biomed Microdevices, 2008, Vol 10, 777–784.


KEYWORDS: biospecimen collection, diagnostics, self-collection, self-sampling, 
remote access, clinical trials, biomedical research, biomarkers

TPOC: Dr. Daniel Wattendorf
Phone: (703) 526-4085<tel:(703)%20526-4085>
Fax: (703) 807-1742<tel:(703)%20807-1742>
Email: daniel.wattendorf@xxxxxxxxx<mailto:daniel.wattendorf@xxxxxxxxx>

2nd TPOC: Dr. Joanne Andreadis
Phone:
Fax:
Email: jsa9@xxxxxxx<mailto:jsa9@xxxxxxx>


SB122-003 TITLE: Minimally Invasive, Self-Collection of Large Volume 
Biospecimens

TECHNOLOGY AREAS: Biomedical

OBJECTIVE: Develop advanced technologies that can be self-operated by a patient 
or a minimally trained operator to collect large volumes/weights of a 
biospecimen for clinical use, such as diagnostic and remote clinical trials, or 
for research applications such as biomarker discovery/validation.

The majority of diagnostic tests and research assays require blood biospecimens 
that are traditionally collected using phlebotomy techniques performed by 
trained personnel. In limited resource areas, such as DoD deployment locations, 
remote or impoverished geographic areas, or emergency response locations, 
absence of blood sample collection by a trained phlebotomist can be a 
significant limitation to clinical care. Lancet or finger stick blood 
collection methods are one solution to minimize the need for these resources 
but suffer from low biofluid volumes that statistically may not contain the 
biomarker(s) of interest at the concentrations necessary for detection or 
clinical correlation. See reference #1 for examples of proteins in blood. 
Solutions are sought that enable the simple self-collection of sufficient 
biospecimen volumes or weights for the detection of low abundance diagnostic 
biomarkers. All biospecimens are of interest and include blood, sweat, tears, 
etc. Technologies developed should be minimally invasive, simple to operate, 
and allow for remote self-collection of a sufficient sample volume (e.g. >100 
microliters for blood) or weight, to allow for detection of a low-abundance 
panel of biomarkers at a reference laboratory or point-of-care setting. 
Potential users include minimally trained individuals and medics in settings 
where phlebotomy is not available.

If the technology is successfully developed, the capability to statistically 
capture low abundance biomarkers by increasing the amount of biospecimen 
collected in low resourced settings is anticipated to widely improve clinical 
care and biomedical research by enabling remote clinical trials, distributed 
remote access diagnostics, public health surveillance and biomarker research.

DESCRIPTION: There is the need for technologies capable of collecting patient 
biospecimens at sufficient volumes or weights, in a manner that allows for 
statistically relevant clinical guidance after the sample has been processed 
and analyzed. At the same time, enabling the capability to self-collect a 
biospecimen could provide a means to more confidently diagnose or track disease 
at its earliest stages, provide an ability to better expand clinical trials 
into remote settings, and increase the diversity of population cohorts needed 
for biomarker research. For example, blood biospecimens are the biofluid of 
choice for most diagnostic applications but require trained phlebotomists to 
collect and process. Simultaneously, there has been a push towards the 
miniaturization of detection technologies (eg. “lab-on-a-chip” and “nano-bio” 
technologies), but there has been a disconnect between sample acquisition and 
downstream analysis in a manner that allows for the detection of low abundance 
analytes.

Aggressive low volume scaling through finger-stick or lancet components affords 
clear advantages for sample preparation, reagent usage, thermal load, 
manipulation, and reaction kinetics, but there is nevertheless the challenge of 
dealing with “the law of small numbers”, or Poisson’s Distribution, which 
indicates that for small biospecimen volumes there may be no targets available 
for amplification or detection. In other words, diagnostic instruments may be 
developed that are small, portable, and require only a few drops of blood, but 
if the target analyte is not present in the small volume, the test could be 
susceptible to false negatives or not provide sufficient statistical confidence 
to provide clinical guidance.

Additionally, biospecimens other than blood, such as sweat, interstitial 
fluids, or tears may have the potential to be a powerful natural repository of 
clinically relevant biomarkers but there lack the technologies for 
self-collection and concentration. Technologies that offer the simplicity of a 
finger stick device (as an example) with the capability to collect larger 
biospecimen volumes or weights would overcome a diagnostic hurdle that limits 
widespread diagnostic testing outside of traditional clinical settings such as 
a clinic or hospital. Therefore, proposals are sought that address large volume 
(eg. >100 microliters for blood) or weight biospecimen collection via a device 
that is simple to operate and minimally invasive. The design should consider 
minimally trained individuals and medics as potential users. Proposers are 
encouraged to consider methods and technologies compatible with clinical 
workflows, good laboratory practices (GLP), and good manufacturing practice 
(GMP) procedures.

PHASE I: Demonstrate feasibility of methods or technologies for large volume or 
weight collection. Proposers must address both the volume/weight of biospecimen 
collected, as well as address how device operation is conducted under 
conditions of minimal invasiveness and ease-of-use. Proposers should aim to 
collect as large a volume or weight as possible (eg. at least 100 microliters 
for blood) while retaining the capability for operation by a minimally trained 
user.

Collection devices may be designed to hold the collected biospecimen within the 
device or to dispense the biospecimen into an instrument or alternate storage 
device. Proposers should demonstrate initial designs and collection 
volumes/weights, and project Phase II collection volume/weight capabilities.

Proposals that demonstrate universal compatibility for downstream analysis 
under a wide dynamic range of analytes are preferred. Of interest are 
quantitative metrics measured with a variety of protein, nucleic acid, 
metabolic and/or other analytes relevant to human biology. Phase I efforts 
should justify the applicability to settings such as home use, and 
consideration of FDA regulations is encouraged.

PHASE II: Phase II efforts should quantify collected biospecimen volume/weight 
and address reproducibility of the collection volume/weight with different 
prototypes under similar and different conditions. Detection of a panel of 
well-characterized, low abundance biomarkers should be demonstrated from 
collected samples using standard laboratory practices. Of interest are 
quantitative metrics measured with a variety of protein, nucleic acid, 
metabolite and/or other analytes relevant to human biology.

Phase II efforts should evaluate the device effectiveness and reproducibility 
when operated by untrained users. Additional interests include demonstrations 
that the proposed technology is developed to include 
standardization/normalization of the biospecimen to reference analyte 
concentrations across collections, with sensitivities that can address sample 
variability.

Manufacturing designs and costs should be considered for all components of the 
device. Compatibility of the collection device with downstream biospecimen 
storage devices and/or analysis technologies should be considered. Device 
potential for FDA clearance as a blood collection device for home use or 
physician office settings should be described.

PHASE III: The technology to be developed should enable blood collection 
outside of a major clinical facility and therefore could have significant 
impact on the clinical diagnostic market. There is a significant commercial 
market for medical diagnostics and home-use physician-office based diagnostic 
testing is a growing element of this market. The developed technology would 
potentially allow collection of sufficient sample in such settings, as well as 
enable clinically valid diagnostic testing and biomarker research. Potential 
commercial partnerships/customers include major diagnostics companies and life 
sciences research technology companies.

The technology to be developed is critical for DoD, as many medics have minimal 
training. Development of a FDA-approved collection device could enable use of 
newly developed diagnostic tests in remote/deployment settings as well as 
expand the military capabilities to perform more effective clinical trials of 
new therapeutics and diagnostics in remote settings or expand capabilities to 
detect and track emerging disease. Potential transition customers include 
Center for Disease Control and Prevention, Air Force Surgeon General, Military 
Health System - Defense Medical Research and Development Program (MHS DMRDP), 
Military Infectious Diseases Research Program (MIDRP), and the commercial 
sector.

REFERENCES:

1. Anderson N.L., Anderson N.G., Mol Cell Proteomics, 2003,2,50.

2. CLIA:http://wwwn.cdc.gov/clia/regs/toc.aspx

3. A. Manz, N. Graber, and H.M. Widmer, Miniaturized Total Chemical Analysis 
Systems: A Novel Concept for Chemical Sensing, Sensors and Actuators, 1990, B1, 
(1 – 6), 244 – 248

4. Kurt E. Petersen, William A. McMillan, Gregory T. A. Kovacs, M. Allen 
Northrup, Lee A. Christel and Farzad Pourahmadi, “Toward Next Generation 
Clinical Diagnostic Instruments: Scaling and New Processing Paradigms,” 
Biomedical Microdevices, 1998, Vol 1 (1), 71-79.

5. Raymond Mariella Jr., “Sample preparation: the weak link in 
microfluidics-based biodetection,” Biomed Microdevices, 2008, Vol 10, 777–784.


KEYWORDS: biospecimen collection, diagnostics, self-collection, self-sampling, 
remote access, clinical trials, biomedical research, biomarkers

TPOC: Dr. Daniel Wattendorf
Phone: (703) 526-4085<tel:(703)%20526-4085>
Fax: (703) 807-1742<tel:(703)%20807-1742>
Email: daniel.wattendorf@xxxxxxxxx<mailto:daniel.wattendorf@xxxxxxxxx>

2nd TPOC: Dr. Joanne Andreadis
Phone:
Fax:
Email: jsa9@xxxxxxx<mailto:jsa9@xxxxxxx>

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  • » [ascct] SBIR opportunity - Kristie Sullivan