SBIR-STTR Award

Mesodissection Device Phase II
Award last edited on: 7/24/13

Sponsored Program
SBIR
Awarding Agency
NIH : NIGMS
Total Award Amount
$810,513
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Nils B Adey

Company Information

AvanSci Bio LLC

1290 West 2320 South Suite D
Salt Lake City, UT 84119
   (801) 972-2377
   contact@avanscibio.com
   www.avanscibio.com
Location: Single
Congr. District: 04
County: Salt Lake

Phase I

Contract Number: 1R43GM100645-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2012
Phase I Amount
$213,000
Mesodissection Device Microscopic analysis of tissue mounted on glass slides is commonly used to study cancer, nonneoplastic entities such as heart disease and diabetes, and normal cell function. At a growing rate, researchers are utilizing various micro and macro tissue dissection techniques to recover specific areas of interest from a slide mounted tissue section for subsequent molecular testing including real time RTPCR, microarrays, sequencing, and mass spectrometry. The primary goal of the proposed Phase I project is to develop a manufacturing prototype of an inexpensive, manually controlled, dissection instrument for slide mounted tissue sections. This device will be based on an existing lab technology coinvented and exclusively licensed from the University of Utah's ARUP Laboratories. The subsequent commercial instrument would fill the need in the biological research market for a mesodissection (100,m resolution) instrument with the low cost, ease of use, and recovery efficiency of manual dissection techniques, but with far better precision. This device will include xy positioning, integrated optics, and multiple choices of specialized tissue removal and recovery tips. The manufacturing prototype will be tested for resolution, efficiency, and accuracy of tissue recovery. Resolution is defined as the difference in ,m between the circumference of the actual post dissection area and that of the originally indicated area for removal. Efficiency is defined as the percentage of tissue recovered from an indicated area measured by DNA quantification. Accuracy is defined as the percentage of desired DNA divided by the total DNA recovered and will be determined by DNA typing. Validation strategies are defined based on a model system of tissue type and slide type. By quantifying the resolution, efficiency and accuracy of DNA recovery in Phase I on prototype instruments we will demonstrate feasibility for Phase II development and commercialization.

Public Health Relevance:
Mesodissection Device The Mesodissection Device will provide a highly affordable system for dissection of tissue sections from glass slides. This device will provide 100m dissection resolution at an order of magnitude lower investment than that required for laser capture microdissection, enabling much broader researcher access to the new technology. The technology will promote productivity and quality of results for researchers working in the fields of histopathology and cancer diagnostics, non!cancer research including heart disease and diabetes, and areas outside of disease research including cell development and cellular function.

Public Health Relevance Statement:
Mesodissection Device The Mesodissection Device will provide a highly affordable system for dissection of tissue sections from glass slides. This device will provide 100m dissection resolution at an order of magnitude lower investment than that required for laser capture microdissection, enabling much broader researcher access to the new technology. The technology will promote productivity and quality of results for researchers working in the fields of histopathology and cancer diagnostics, non!cancer research including heart disease and diabetes, and areas outside of disease research including cell development and cellular function.

Project Terms:
anticancer research; Area; Aspirate substance; base; Biological Assay; Biological Models; biological research; Cancer Diagnostics; Cell physiology; Cells; Clinical Research; commercialization; cost; design; design and construction; Development; Devices; Diabetes Mellitus; digital; digital imaging; Discipline; Disease; Dissection; DNA; DNA Fingerprinting; Effectiveness; Elements; Excision; expectation; Feedback; Genomics; Glass; Goals; Heart Diseases; Height; Histocompatibility Testing; Histopathology; Image; improved; instrument; interest; Investments; Laboratories; laser capture microdissection; Licensing; Liquid substance; Malignant Neoplasms; Manuals; Marketing; Mass Spectrum Analysis; Measures; Mechanics; Methods; Microdissection; Microscopic; Molecular; Motor; Movement; new technology; Normal Cell; Nucleic Acids; Optics; Performance; Phase; Positioning Attribute; pressure; Procedures; Process; Productivity; prototype; Recovery; Relative (related person); Research; Research Personnel; Resolution; Reverse Transcriptase Polymerase Chain Reaction; sample fixation; Sampling; Selection Bias; Slide; Specificity; Speed (motion); Staging; System; Techniques; Technology; Testing; Thick; Time; Tissues; Universities; Utah; Vacuum; Validation; Work

Phase II

Contract Number: 2R44GM100645-02
Start Date: 3/1/12    Completed: 3/31/14
Phase II year
2013
Phase II Amount
$597,513
Microscopic analysis of tissue mounted on glass slides is commonly used to study cancer, non-neoplastic entities such as heart disease and diabetes, and normal cell function. Researchers utilize micro and macro tissue dissection techniques in order to recover specific areas of these tissue sections from the slides for subsequent molecular analysis including real time PCR, microarrays, sequencing, and mass spectrometry. When the area to be dissected is relatively large (a few mm), manual macrodissection is adequate. If single cell resolution is required, Laser Microdissection (LMD) is often employed. Both of these methods have their short comings, particularly when an intermediate level of resolution is needed (100¿m to 1 mm). The Phase II project continues the goal to develop the MESO system, which is an affordable, easy to use, tissue milling and fragment recovery technology for slide mounted tissue sections. AvanSci Bio has met the Specific Aims of the Phase I grant by developing the manufacturing prototype and successfully completing the planned performance evaluation experiments. However, challenging improvements in accuracy, resolution, and sample preparation methods are necessary to expand the usability of the MESO system. In addition, significantly more testing and validation are necessary to ensure the system performs reliably and up to expectations and to encourage adoption. The two Specific Aims of this Phase II include: 1) optimization of sample prep and milling conditions, beta site testing including performance evaluation and validation, and novel application development; and 2) design refinement primarily to the stage precision and blade pressure control, and improved hardness of xScisor blade and more refined fluid control. This new technology and product is expected to further research and clinical diagnostics by greatly reducing the cost and therefore broadening availability of high performance microdissection. We have demonstrated feasibility for Phase II development and commercialization. Our Phase III goal will be to ultimately manufacture and distribute the MESO System, including instrumentation, software, and consumables to clinicians and researchers doing slide mounted tissue dissection.

Public Health Relevance Statement:


Public Health Relevance:
The Mesodissection Device will provide a highly affordable system for dissection of tissue sections from glass slides. This device will provide 50-100¿m accuracy and resolution at more than an order of magnitude lower cost than that required for laser microdissection systems, enabling much broader researcher access to the new technology. The mesodissection technology will promote productivity and quality of results for researchers working in the fields of histopathology and cancer diagnostics, non-cancer research including heart disease and diabetes, and areas outside of disease research including cell development and cellular function.

Project Terms:
Adoption; American Association of Cancer Research; Area; Biochemical; Biological Assay; biological research; Cancer Diagnostics; Cell physiology; Cells; Clinical; Clinical Research; commercialization; Complex; Computer software; cost; design; Development; Devices; Diabetes Mellitus; Diagnostic; Disease; Dissection; Documentation; Ensure; Evaluation; expectation; Feedback; Frozen Sections; Funding; Future; Glass; Goals; Grant; Hardness; Heart Diseases; Histopathology; Immobilization; improved; instrument; instrumentation; interest; laser capture microdissection; Lasers; Liquid substance; Malignant Neoplasms; Manuals; Market Research; Marketing; Mass Spectrum Analysis; Measures; meetings; Methods; Microdissection; Microscopic; Molecular Analysis; molecular pathology; Movement; new technology; next generation sequencing; Normal Cell; novel; Peer Review; Performance; performance tests; Phase; posters; Preparation; pressure; Productivity; Progress Reports; Protein Analysis; prototype; public health relevance; Publications; Recovery; Research; Research Personnel; research study; Research Support; Resolution; Running; Sampling; Site; Slide; Small Business Innovation Research Grant; Staging; success; System; Techniques; Technology; Testing; Time; Tissues; usability; Validation; web site; Work