Company
Portfolio Data
Back to Company Search20 20 Genesystems Inc
UEI: N/A
Number of Employees: 20
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
SBIR/STTR Involvement
Year of first award: 2003
14
Phase I Awards
3
Phase II Awards
21.43%
Conversion Rate
$1,908,291
Phase I Dollars
$4,149,581
Phase II Dollars
$6,057,872
Total Awarded
Awards
IGF::OT::IGF RandD- MEDICAL: BIOMEDICAL (BASIC RESEARCH)
Amount: $749,959 Topic: NCI
Not Available
Tagged as:
SBIR
Phase II
2014
HHS
NIH
PredicTOR: predicting patient response to mTOR pathway inhibitors prior to treatm
Amount: $2,750,000 Topic: NCI
DESCRIPTION (provided by applicant): The promise of personalized medicine relies on the development of diagnostic tests to categorize patients within small cohorts who will benefit from specific treatments. 20/20 GeneSystems, Inc. (20/20) is a small business concern focused on the development of diagnostics for personalized medicine. Towards this end, 20/20 has developed, with the support of the NCI's SBIR program, an improved approach to immunohistochemistry ( Layered-IHC also referred to as Layered Expression Scanning (LES)) that permits 10 or more biomarkers to be measured simultaneously from a single section of biopsied tissue while maintaining morphology. No other marketed technology has this dual capability. This SBIR Phase II Bridge Award proposal aims to develop, clinically validate and commercialize a series of companion diagnostic tests for cancer therapeutic agents, the efficacy of which may be influenced by the activity levels of proteins in the mTOR pathway (including PI3-K, Akt, and mTOR). The mTOR pathway is an important pathway in tumorigenesis and currently the target of several drugs on the market for kidney cancer (TORISEL(R) and AFINITOR(R)) as well as over a dozen compounds in Phase I-III trials for multiple tumor types. It has been demonstrated that a more complete characterization of the mTOR pathway is required to best determine the appropriateness of a specific therapy and as such measurement of a panel of multiple biomarkers will be required. Thus 20/20's L-IHC system is a most appropriate system for the development of mTOR companion diagnostics. This SBIR Phase II Bridge Award proposal seeks to develop what is likely the first mTOR companion diagnostic, PredicTOR , and clinical validation of this test in two or three cancer types, specifically kidney cancer, breast cancer and lung cancer. This work will be done in consultation with the FDA and will include the necessary protocols and procedures to obtain regulatory acquiescence or approval of the products as laboratory developed tests (LDTs). To increase the likelihood of successful and timely commercialization, applicant plans to match the requested 2.75 million in government funding (over 3 years) with at least 3.75 million in private sector investment. This private investment will come from one or more strategic partners ( 2 million) and individual investors ( 1.75 million). 20/20 has a proven track record in procuring both equity investors and corporate partnerships and has already successfully commercialized innovative products developed with federal funding. Commercialization of these products is expected by the conclusion of the funding period. PUBLIC HEALTH RELEVANCE: This SBIR Phase II Bridge Award proposal seeks to develop what is likely the first mTOR companion diagnostic, PredicTOR , and clinical validation of this test in two or three cancer types. This work will utilize 20/20 GeneSystems, Inc. proprietary L-IHC t=technology and will be done in consultation with the FDA and will include the necessary protocols and procedures to obtain regulatory acquiescence or approval of the products as laboratory developed tests (LDTs).
Tagged as:
SBIR
Phase II
2010
HHS
NIH
A COMPANION DIAGNOSTIC FOR PROGNOSIS OF KIDNEY CANCER
Amount: $199,597 Topic: NCI
This contract was awarded by the National Cancer Institute's Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Program under the funding opportunity "Contract Topic: 277 Companion Diagnostics: Predictive and Prognostic Tests Enabling Personalized Medicine in Cancer Therapy."
Tagged as:
SBIR
Phase I
2010
HHS
NIH
Autoantibody Profiling for Serological Detection of Head and Neck Cancer
Amount: $217,801
DESCRIPTION (provided by applicant): SBIR grant support is being sought by 20/20 GeneSystems, Inc. (20/20), a small biotech company, to help us advance what we believe will become the first blood test to be routinely employed to aid in the early detection of head and neck cancer. Despite recent advances in both diagnostic and therapeutic modalities, long-term prognosis for patients affected by advanced stage head and neck squamous cell carcinoma (HNSCC) remains dismal with 5-year survival less than 40%. This grim prognosis is in distinct contrast to the more than 80% chance of cure for those patients who present with early stage cancer. Unfortunately, more than two-third of patients with HNSCC are diagnosed only after the disease is advanced. Failure to diagnose this cancer early is mainly attributed to the unavailability of a screening test for high risk patients as well as frequent misdiagnosis of early stage cancer by primary physicians. An autoantibody immunoassay for head and neck squamous cell carcinoma (HNSCC) is expected to become a novel non-invasive tool for early diagnosis. Our long term strategy, which would become the subject of a Phase II SBIR grant application should Phase I work be successful, is to develop a tobacco user's chip to screen for both HNSCC and lung cancer in one blood sample, because current and former smokers are at high risk for both diseases. The serological test should have a significant impact on the quality of medical care for persons at risk, particularly for over 20% of the US population who are users of tobacco and/or alcohol products. PUBLIC HEALTH RELEVANCE: A blood test for early detection of head and neck cancer could provide a cost-effective screening approach when applied to presently known high risk groups, who are: users of tobacco and/or alcohol, the immune-compromised, and those with premalignant lesions. It would enable a viable strategy for reducing the severe mortality rate of this disease.
Tagged as:
SBIR
Phase I
2009
HHS
NIH
Profiling Autoantibodies in Non-small Cell Lung Cancer with Fusion Protein-Peptid
Amount: $183,927
DESCRIPTION (provided by applicant): Approximately 135,000 new cases of non-small cell lung cancer (NSCLC) are diagnosed each year in the USA, yet only 20%-25% of those patients will be diagnosed at a sufficiently early stage to be cured by surgical or other procedures. When used in concert with radiographic imaging, a sensitive and specific blood test for NSCLC could be a clinically valuable and cost-effective tool for early diagnosis. The immune system responds to tumor-associated proteins by secreting autoantibodies long before metastasis occurs. Autoantibody profiling for this important group of circulating tumor markers in peripheral blood has lead us to the identification of appropriate target peptides. Using a T7 phage display library derived from the cDNA of a NSCLC line, we have developed a panel of eight peptides which were formatted as a protein microarray for use in a simple capture immunoassay (Zhong et al. 2006, J. Thoracic Oncol. 1(6), 513). When probed with a blood sample, the array can identify the presence of tumor-associated antibodies in NSCLC but not in normals with both sensitivity and a specificity exceeding 90% at early and later stages of the disease. As used to measure tumor-associated antibodies in serum from a cohort of cancer patients and risk- matched controls, this test affords predictive accuracy that exceeds that of currently available circulating NSCLC- associated protein markers. The overall purpose of this application is to achieve three aims: 1) subclone the DNA sequences encoding the eight peptides identified in our initial discovery effort into two fusion-expression vectors, 2) prepare microarrays of the fusion peptides described in aim 1 and demonstrate that they enable measurement of autoantibody profiles that can distinguish cancer from normal blood samples with unprecedented sensitivity and specificity. 3) Finally, we will acquire a cohort of 30 NSCLC and 30 at risk controls and validate the above peptides as bona fide lung cancer biomarkers using protein microarrays. Microarrays of the purified peptides will be used for rigorous optimization and standardization of all technical and clinical performance measures for the multi-target immunoassay. Our initial clinical application will be early detection of lung cancer, although multiple applications in lung cancer management are rational. Our data shows feasibility and proof of concept that supports the rationale for further development and testing of this approach. A subsequent Phase II application will lead to use of an appropriate platform for definitive marker validation trials for application to clinical screening of NSCLC. Thus the primary goal of this application is to develop a novel blood test for NSCLC that can be rapidly translated into clinical practice. PUBLIC HEALTH RELEVANCE: A blood test for early detection of lung cancer could provide a cost-effective screening approach, and in concert with CT scanning would enable a viable strategy for reducing the severe mortality rate of this disease.
Tagged as:
SBIR
Phase I
2009
HHS
NIH
Profiling ER, PR, EGFR and HER2 in Breast Cancer Using Multiplex Tissue Immusta
Amount: $649,622
DESCRIPTION (provided by applicant): We propose to develop a novel method and kit for profiling the expression and activation of signal transduction proteins in breast tumors. The goal is to create new companion diagnostics to better select patients like ly to respond to targeted therapies, including Herceptin. and novel tyrosine kinase inhibitors. 20/20 will utilize its proprietary Layered Expression Scanning (LES) technology. Transfer of antibody probes from a single tissue section to numerous bioaffinit y membranes permits multiple target antigens (up to 50 if needed) to be assessed in a quantitative manner while preserving the local spatial orientation of the targets relative to the tissue section. During Phase II, we will demonstrate its tissue applicat ions with human breast tissue sections from clinical trials in breast cancer patients treated with growth factor and Akt inhibitors. Biomarker quantification will be standardized and calibrated to clearly demonstrate a clinical benefit in comparison with s ubjective visual estimation. The product would have utility in both a research and clinical laboratory setting. Importantly, the system is open-ended to the addition of new prognostic markers and drug targets into the assay panel. There are several anticip ated advantages of the layered membrane platform over current histopathology tools such as immunohistochemistry (IHC). These include conservation of tissue (such as for core needle biopsies) and the ability to simultaneously profile multiple signaling prot eins in both normal and phosphorylated form, in a single tissue section. PUBLIC HEALTH RELEVANCE:Our options for breast cancer diagnosis and treatment will be increasingly taking advantage of information obtained from tumor profiling assays, which will ind icate customized therapies for each form of the disease. The novel diagnostic techniques to be researched will allow for microscopic profiling of tiny amounts of tissue for numerous cancer-causing molecules. There will be applications in pre-clinical studi es and drug trials, which will aim to invent novel treatment strategies using combinations of drugs that block growth factor' molecules.
Tagged as:
SBIR
Phase II
2008
HHS
NIH
Peptide Array for Profiling of Autoantibodies in Non-small Cell Lung Cancer
Amount: $165,288
DESCRIPTION (provided by applicant): Approximately 135,000 new cases of non-small cell lung cancer (NSCLC) are diagnosed each year in the USA, yet only 20%-25% of those patients will be diagnosed at a sufficiently early stage to be cured by surgical or other procedures. When used in concert with radiographic imaging, a sensitive and specific blood test for NSCLC could be a clinically valuable and cost-effective tool for early diagnosis. The immune system responds to tumor-associated protein by secreting autoantibodies long before metastasis occurs. Autoantibody profiling for this important group of circulating tumor markers in peripheral blood has lead us to the identification of appropriate target peptides. We have developed a panel of 21 short peptides which were formatted as a protein microarray for use in a simple capture immunoassay. When probed with a blood sample the array can identify the presence of tumor-associated antibodies in NSCLC but not in normals with both sensitivity and a specificity exceeding 90% at early and later stages of the disease. As used to measure tumor-associated antibodies in serum from a cohort of cancer patients and risk-matched controls, this test affords predictive accuracy that exceeds that of currently available circulating NSCLC- associated protein markers. The overall purpose of this application is to prepare microarrays of a panel of peptide targets and to demonstrate that they enable measurement of autoantibody profiles that can distinguish cancer from normal blood samples with unprecedented sensitivity and specificity. Microarrays of the purified peptides will be used for rigorous optimization and standardization of all technical and clinical performance measures for the multi-target immunoassay. Our initial clinical application will be early detection of lung cancer, although multiple applications in lung cancer management are rational. Our data shows feasibility and proof of concept that supports the rationale for further development and testing of this approach. A subsequent Phase II application will lead to use of an appropriate platform for definitive marker validation trials for application to clinical screening of NSCLC. Thus the primary goal of this application is to develop a novel blood test for NSCLC that can be rapidly translated into clinical practice. A blood test for early detection of lung cancer could provide a cost-effective screening approach, and in concert with CT scanning would enable a viable strategy for reducing the severe mortality rate of this disease.
Tagged as:
SBIR
Phase I
2007
HHS
NIH
Profiling EGFR and Her2 in Breast Cancer using Multiplex Tissue Immunostaining
Amount: $117,930
DESCRIPTION (provided by applicant): We propose to develop a novel method and kit for profiling the expression and activation of signal transduction proteins in breast tumors. The goal is to create new "companion" diagnostics to better select patients likely to respond to targeted therapies, including Herceptin(r) and novel tyrosine kinase inhibitors. 20/20 will utilize its proprietary layered peptide array (LPA) technology. Transfer of antibody probes from a single tissue section to numerous bioaffinity membranes permits multiple target antigens (up to 50 if needed) to be assessed in a quantitative manner while preserving the local spatial orientation of the targets relative to the tissue section. The immediate goals are to develop a panel of 7 assays (comprising antigen-coated membranes and relevant antibodies), and to demonstrate their use for profiling AKT signaling in cultured breast cancer cells and archival tissues. During Phase II, we will demonstrate its tissue applications with animal models, and with human breast tissue sections from clinical trials in breast cancer patients treated with growth factor and Akt inhibitors. The product would have utility in both a research and clinical laboratory setting. Importantly, the system is open-ended to the addition of new prognostic markers and drug targets into the assay panel. There are several anticipated advantages of the layered membrane platform over current histopathology tools such as immunohistochemistry (IHC). These include conservation of tissue (such as for core needle biopsies) and the ability to simultaneously profile multiple signaling proteins in both normal and phosphorylated form. Our options for breast cancer diagnosis and treatment will increasingly take advantage of information obtained from tumor profiling assays, which will indicate customized therapies for each form of the disease. The novel diagnostic techniques to be researched will allow for microscopic profiling of tiny amounts of tissue for numerous cancer-causing molecules. There will be applications in pre-clinical studies and drug trials, which will aim to invent novel treatment strategies using combinations of drugs that block 'growth factor' molecules.
Tagged as:
SBIR
Phase I
2007
HHS
NIH
Auto-antibody profiling of non-small cell lung cancer
Amount: $177,279
DESCRIPTION (provided by applicant): Tumor markers, measured in peripheral blood, could assist in diagnosis and management of non-small cell lung cancer (NSCLC) and potentially improve historically dismal outcomes. Circulating antibodies, generated to a wide range of tumor-associated proteins, can be translated into a valuable blood test for lung cancer. Preliminary data supports this hypothesis. We have successfully used phage-display, biopan enrichment techniques and high throughput fluorescent array screening to identify multiple known and unknown tumor-associated proteins specifically recognized by circulating tumor-associated antibodies NSCLC patients but not in normals. A panel of phage-expressed proteins arrayed on a glass slide microarray used to measure tumor-associated antibodies in serum from a cohort of cancer patients and risk-matched controls affords predictive accuracy that exceeds that of currently available circulating NSCLC-associated protein markers. Although fluorescent microarray system is an ideal tool for identifying proteins recognized by tumor-associated antibodies, it is not a commercial-ready platform. The intent of this application is to incorporate these markers into a layered protein array (LPA), a 96-well ELISA type platform that has been developed for clinical diagnostics. The high-throughput format of the LPA allows measurement of multiple antibody markers simultaneously will be central to the application is a perfect complement to biomarker identification. The LPA will be initially constructed and tested using a panel of proteins that have already been identified. Our initial application will be early detection of lung cancer, although multiple applications in lung cancer management are rational. Data shows feasibility and proof of concept that supports the rationale for further development and testing of this approach. Subsequent .Phase II application will evaluate an assay developed in this Phase I project for application to screening of NSCLC. Thus the primary goal of this application is to develop a novel blood test for NSCLC that can be rapidly translated into clinical practice. Success in this project will herald similar development in other malignant diseases. Relevance to Public Health. A blood test for lung cancer could improve the capability and cost- effectiveness of early detection as a viable strategy for reducing mortality from this disease. Relevance to Public Health. A blood test for lung cancer could improve the capability and cost-effectiveness of early detection as a viable strategy for reducing mortality from this disease.
Tagged as:
STTR
Phase I
2006
HHS
NIH
Auto-antibody profiling of non-small cell lung cancer
Amount: $177,279
DESCRIPTION (provided by applicant): Tumor markers, measured in peripheral blood, could assist in diagnosis and management of non-small cell lung cancer (NSCLC) and potentially improve historically dismal outcomes. Circulating antibodies, generated to a wide range of tumor-associated proteins, can be translated into a valuable blood test for lung cancer. Preliminary data supports this hypothesis. We have successfully used phage-display, biopan enrichment techniques and high throughput fluorescent array screening to identify multiple known and unknown tumor-associated proteins specifically recognized by circulating tumor-associated antibodies NSCLC patients but not in normals. A panel of phage-expressed proteins arrayed on a glass slide microarray used to measure tumor-associated antibodies in serum from a cohort of cancer patients and risk-matched controls affords predictive accuracy that exceeds that of currently available circulating NSCLC-associated protein markers. Although fluorescent microarray system is an ideal tool for identifying proteins recognized by tumor-associated antibodies, it is not a commercial-ready platform. The intent of this application is to incorporate these markers into a layered protein array (LPA), a 96-well ELISA type platform that has been developed for clinical diagnostics. The high-throughput format of the LPA allows measurement of multiple antibody markers simultaneously will be central to the application is a perfect complement to biomarker identification. The LPA will be initially constructed and tested using a panel of proteins that have already been identified. Our initial application will be early detection of lung cancer, although multiple applications in lung cancer management are rational. Data shows feasibility and proof of concept that supports the rationale for further development and testing of this approach. Subsequent .Phase II application will evaluate an assay developed in this Phase I project for application to screening of NSCLC. Thus the primary goal of this application is to develop a novel blood test for NSCLC that can be rapidly translated into clinical practice. Success in this project will herald similar development in other malignant diseases. Relevance to Public Health. A blood test for lung cancer could improve the capability and cost- effectiveness of early detection as a viable strategy for reducing mortality from this disease. Relevance to Public Health. A blood test for lung cancer could improve the capability and cost-effectiveness of early detection as a viable strategy for reducing mortality from this disease.
Tagged as:
SBIR
Phase I
2006
HHS
NIH