SBIR-STTR Award

Commercialization of Magneto-Nanosensor Immunoassay Platform for Cancer Diagnosis
Award last edited on: 4/15/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$2,921,869
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Luis Carbonell

Company Information

MagArray Inc

521 Cottonwood Drive Suite 121
Sunnyvale, CA 95035
   (408) 599-1018
   N/A
   www.magarray.com
Location: Single
Congr. District: 17
County: Santa Clara

Phase I

Contract Number: N/A
Start Date: 6/1/2013    Completed: 5/31/2016
Phase I year
2012
Phase I Amount
$100,000
This project seeks to optimize a promising magneto-nanosensor technology for use in cancer diagnosis. By adapting a common technology from the computer disk drive industry, this simple device enables researchers to simultaneously detect multiple proteins, or biomarkers, at ultra low concentrations in biological fluids. The abundance and change over time of several of these biomarkers, when taken together, can be a powerful diagnostic tool. At this time, the tools required to measure these biomarkers, such as mass spectrometry or ELISA immunoassays, are slow, expensive, difficult to use, and often not very reproducible. In addition, many interesting biomarkers are present at such low concentrations that they simply cannot be detected with any but the most sophisticated and involved methods. The technology under development combines the advantages of high sensitivity, ease of use, rapid quantification, and low cost. These drastic improvements are possible in part due to the use of extremely sensitive giant magnetoresistive (GMR) sensors, and also because there are no natural magnetic signal sources in a blood sample, which results in a very low background signal. Additionally, these sensors have been modified to detect only those magnetic nanoparticle labels which are actually bound to the sensors - unbound labels floating nearby are almost completely ignored. That means that, unlike most other assay technologies, it is not necessary to remove the excess labels to determine the result. This allows the assay to be partially or completely wash-free, which again greatly increases the sensitivity and ease of use. Furthermore, no laser or complex optics are required because the signal is a simple change in electrical resistance of the sensor. This means that the ancillary instrumentation can be very simple and cost-efficient. With an initial focus on lung cancer, where there are no effective methods for early detection of the disease, researchers are attempting to validate a panel of six biomarkers that have been associated with asymptomatic lung cancer. The long term goal is to have a diagnostic test that allows doctors to diagnose patients when they are still in Stage I and face survival rates of 70-80%, as opposed today's situation where most patients don't get diagnosed until they reach Stage IIIB or IV and face less than a 10% chance of survival.

Public Health Relevance Statement:


Public Health Relevance:
PROJECT NARRATIVE Researchers are using a promising magneto-nanosensor technology to develop a novel diagnostic test for early detection of lung cancer. This simple blood test would greatly improve patient survival by making it possible to diagnose lung cancer in its early stages when it has a much better chance of being successfully treated.

Project Terms:
Address; Adjuvant; Agreement; Annexins; Area Under Curve; Autoantibodies; base; Binding (Molecular Function); Biological; Biological Assay; Biological Markers; Blood specimen; Blood Tests; cancer diagnosis; Cancer Patient; Clinical; Collaborations; commercialization; Complex; Computers; cost; design; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Disease; Disulfides; Doctor of Philosophy; Dose; Early Diagnosis; Electrical Resistance; Engineering; Enzyme-Linked Immunosorbent Assay; Epidermal Growth Factor Receptor; Epididymis; Evaluation; Face; Feedback; Fred Hutchinson Cancer Research Center; Future; Goals; Hospitals; Howard Temin Award; Human; Immunoassay; improved; indexing; Industry; instrument; instrumentation; interest; Label; Lasers; Liquid substance; Magnetism; Malignant neoplasm of lung; Malignant neoplasm of ovary; Malignant Neoplasms; Market Research; Marketing; Mass Spectrum Analysis; Measures; meetings; Methods; Modeling; Monitoring for Recurrence; nanoparticle; nanosensors; novel diagnostics; Optics; Patients; Performance; Phase; Physicians; Principal Investigator; programs; Progressive Disease; Proteins; public health relevance; Reader; Receiver Operating Characteristics; Regulatory Pathway; Reporting; Research Personnel; Sampling; screening; Screening for Lung Cancer; Screening procedure; sensor; Serum; Signal Transduction; Small Business Innovation Research Grant; Solid; Source; Staging; Summary Reports; Survival Rate; System; Technology; Testing; Time; tool; Translations; Validation; verification and validation; Work; X-Ray Computed Tomography; YWHAQ gene

Phase II

Contract Number: 2R44CA165296-02
Start Date: 6/25/2007    Completed: 6/30/2016
Phase II year
2013
(last award dollars: 2015)
Phase II Amount
$2,821,869

This project seeks to optimize a promising magneto-nanosensor technology for use in cancer diagnosis. By adapting a common technology from the computer disk drive industry, this simple device enables researchers to simultaneously detect multiple proteins, or biomarkers, at ultra low concentrations in biological fluids. The abundance and change over time of several of these biomarkers, when taken together, can be a powerful diagnostic tool. At this time, the tools required to measure these biomarkers, such as mass spectrometry or ELISA immunoassays, are slow, expensive, difficult to use, and often not very reproducible. In addition, many interesting biomarkers are present at such low concentrations that they simply cannot be detected with any but the most sophisticated and involved methods. The technology under development combines the advantages of high sensitivity, ease of use, rapid quantification, and low cost. These drastic improvements are possible in part due to the use of extremely sensitive giant magnetoresistive (GMR) sensors, and also because there are no natural magnetic signal sources in a blood sample, which results in a very low background signal. Additionally, these sensors have been modified to detect only those magnetic nanoparticle labels which are actually bound to the sensors - unbound labels floating nearby are almost completely ignored. That means that, unlike most other assay technologies, it is not necessary to remove the excess labels to determine the result. This allows the assay to be partially or completely wash-free, which again greatly increases the sensitivity and ease of use. Furthermore, no laser or complex optics are required because the signal is a simple change in electrical resistance of the sensor. This means that the ancillary instrumentation can be very simple and cost-efficient. With an initial focus on lung cancer, where there are no effective methods for early detection of the disease, researchers are attempting to validate a panel of six biomarkers that have been associated with asymptomatic lung cancer. The long term goal is to have a diagnostic test that allows doctors to diagnose patients when they are still in Stage I and face survival rates of 70-80%, as opposed today's situation where most patients don't get diagnosed until they reach Stage IIIB or IV and face less than a 10% chance of survival.

Public Health Relevance Statement:


Public Health Relevance:
PROJECT NARRATIVE Researchers are using a promising magneto-nanosensor technology to develop a novel diagnostic test for early detection of lung cancer. This simple blood test would greatly improve patient survival by making it possible to diagnose lung cancer in its early stages when it has a much better chance of being successfully treated.

Project Terms:
Address; Adjuvant; Agreement; Annexins; Area Under Curve; Autoantibodies; base; Binding (Molecular Function); Biological; Biological Assay; Biological Markers; Blood specimen; Blood Tests; cancer diagnosis; Cancer Patient; Clinical; Collaborations; commercialization; Complex; Computers; cost; design; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Disease; Disulfides; Doctor of Philosophy; Dose; Early Diagnosis; Electrical Resistance; Engineering; Enzyme-Linked Immunosorbent Assay; Epidermal Growth Factor Receptor; Epididymis; Evaluation; Face; Feedback; Fred Hutchinson Cancer Research Center; Future; Goals; Hospitals; Howard Temin Award; Human; Immunoassay; improved; indexing; Industry; instrument; instrumentation; interest; Label; Lasers; Liquid substance; Magnetism; Malignant neoplasm of lung; Malignant neoplasm of ovary; Malignant Neoplasms; Market Research; Marketing; Mass Spectrum Analysis; Measures; meetings; Methods; Modeling; Monitoring for Recurrence; nanoparticle; nanosensors; novel diagnostics; Optics; Patients; Performance; Phase; Physicians; Principal Investigator; programs; Progressive Disease; Proteins; public health relevance; Reader; Receiver Operating Characteristics; Regulatory Pathway; Reporting; Research Personnel; Sampling; screening; Screening for Lung Cancer; Screening procedure; sensor; Serum; Signal Transduction; Small Business Innovation Research Grant; Solid; Source; Staging; Summary Reports; Survival Rate; System; Technology; Testing; Time; tool; Translations; Validation; verification and validation; Work; X-Ray Computed Tomography; YWHAQ gene