Collaborations

In addition to collaborations focused on HPV-associated cancers, CGI has established strong research collaborations with key thought leaders in oncology and major cancer centers within the U.S. and abroad. These collaborations enable us to develop and validate proprietary tests in a clinical setting with the gained access to robust patient data. CGI’s abundant knowledge in oncology and vast testing capabilities allows for these proprietary tests to be tailored to the collaborators’ needs and specifications. Below is a summary of our active key collaborations.

Cleveland Clinic

CGI entered into a collaborative research agreement and non-exclusive license arrangement with Cleveland Clinic to start development around a renal cell carcinoma diagnostic focused on validating genomic biomarkers from DNA. CGI received numerous clinical specimens from the Cleveland Clinic and associated clinical and laboratory data was used for the validation of CGI’s proprietary microarray, UroGenRA™–Kidney. Samples were analyzed in CGI’s clinical laboratory and resulting data will be published jointly.

Dana Farber Cancer Institute

A research collaboration with the Dana Farber Cancer Institute was initiated in 2013. CGI provided the collaborating doctor with genomic regions to be used to classify a robust number of specimens for outcome in chronic lymphocytic leukemia (CLL). The regions provided by CGI were determined using CGI’s MatBA®-CLL array. The collaborating doctor’s data and CGI’s data were combined for the clinical validation of a CLL outcome scheme.

Georgia Health Sciences University

CGI entered into a research collaboration agreement for the development of molecular testing to facilitate diagnosis, prognosis and management of DLBCL patients. The specimens provided by the investigators will be used for ABC-GCB subtype classification by immunohistochemistry to identify and further validate genomic biomarkers for DLBCL using CGI’s proprietary MatBA®-DLBCL array. CGI also entered into a biological material transfer agreement for the validation of CGI’s proprietary FHACT™ probe in the diagnosis and disease management of head and neck cancers.

Hackensack University Medical Center

CGI entered into a biological material transfer agreement with the John Theurer Cancer Center at the Hackensack University Medical Center. The John Theurer Cancer Center provides CGI with specimens for chronic lymphocytic leukemia (CLL) testing. CGI analyzes these specimens with its proprietary MatBA® -CLL array-CGH assay. Results from this study will be prepared for joint publication.

Kamineni Hospital

This focus of this collaboration is to evaluate FHACT™, CGI’s proprietary FISH-based HPV-Associated Cancer Test, as a screening tool for the identification of pre-cancerous and cancerous cervical cells. CGI provides the FHACT™ DNA-FISH probe to the collaborating doctor’s laboratory where the assay is performed on Pap smears obtained during routine health visits. The data from this collaboration is analyzed jointly and publications will be jointly produced.

Mayo Clinic

CGI and Mayo Clinic launched a joint venture, OncoSpire Genomics. The objectives of this venture are to try to discover and validate biomarkers in specific hematologic and urogenital disorders utilizing next-generation sequencing with a possible expansion into other solid tumors, such as esophageal, head and neck, breast and lung cancers. Additionally, the joint venture entity would engage in biomarker discovery utilizing Mayo’s next-generation sequencing facility and the development of commercial products in the form of diagnostic products and services, as well as early stage therapeutic markers.

Memorial Sloan-Kettering Cancer Center

Multiple research collaborations have been formed with MSKCC with focuses in kidney cancer, chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL).

MSKCC provided CGI with a multitude of lymphoma specimens of varying histologies with known clinical outcomes for the and clinical validations of MatBA® for CLL, DLBCL, MCL and FL. CGI also received cores of FFPE tumor material spear-heading and providing justification for the use of this tissue type in array-CGH.

A biological material transfer agreement allowed the evaluation the first application of CGI’s proprietary array-CGH product line, UroGenRA™, in the diagnosis and subtyping of renal mass aspirates/core biopsies. The specimens were also used to compare UroGenRA™ with routine pathology testing.

National Cancer Institute

The collaboration with NCI was formed to interrogate the potential role of identification of host genomic abnormalities by FISH (Fluorescence in situ hybridization) as a screening tool for the detection of HPV-associated pre-cancerous cells and cancerous cells. NCI provided liquid biopsy specimens for analysis by FHACT™, CGI’s proprietary FISH-based HPV-Associated Cancer Test. The NCI also provided anal liquid biopsy specimens that will be used for the evaluation of FHACT™ in anal cancer.

North Shore-Long Island Jewish Health System

Leading clinicians and scientists from North Shore LIJ have provided a significant quantity of clinical specimens in a study of chronic lymphocytic leukemia (CLL) that were used for the clinical validation of CGI’s proprietary microarray, MatBA® -CLL. CGI analyzed these samples in-house and published the resulting data jointly. CGI will use the same samples for additional collaborative studies involving the search for additional molecular biomarkers of CLL.

Stanford University

Stanford University recently granted CGI a worldwide, non-exclusive license under U.S. Patent No. 7,622,253 and U.S. Patent No. 7,332,280 directed to a method and an assay for the classification of diffuse large B-cell lymphoma (DLBCL) patients based on risk stratification and a predictive model for patient survival. The licensed technology analyzes the expression of six genes by a real-time PCR methodology in conjunction with an algorithm. The test is being commercialized by CGI Laboratories as SETRAâ„¢, Six gene Expression Treatment Response Assay.

University of Iowa Cancer Center

CGI entered into a material transfer agreement with the University of Iowa Research Foundation, whereby CGI received specimens useful to studies evaluating the FHACT™ assay in cervical liquid biopsy specimens. Study data is analyzed jointly. CGI also entered into a biological transfer agreement with the University of Iowa for the development and validation of molecular tests, such as MatBA®-DLBCL, to improve the diagnosis, prognosis and management of diffuse large B-cell lymphoma (DLBCL).

Dana Farber Cancer Institute

A research collaboration with the Dana Farber Cancer Institute was initiated in 2013. CGI provided the collaborating doctor with genomic regions to be used to classify a robust number of specimens for outcome in chronic lymphocytic leukemia (CLL). The regions provided by CGI were determined using CGI’s MatBA®-CLL array. The collaborating doctor’s data and CGI’s data were combined for the clinical validation of a CLL outcome scheme.

Hackensack University Medical Center

CGI entered into a biological material transfer agreement with the John Theurer Cancer Center at the Hackensack University Medical Center. The John Theurer Cancer Center provides CGI with specimens for chronic lymphocytic leukemia (CLL) testing. CGI analyzes these specimens with its proprietary MatBA® -CLL array-CGH assay. Results from this study will be prepared for joint publication.

North Shore-Long Island Jewish Health System

Leading clinicians and scientists from North Shore LIJ have provided a significant quantity of clinical specimens in a study of chronic lymphocytic leukemia (CLL) that were used for the clinical validation of CGI’s proprietary microarray, MatBA® -CLL. CGI analyzed these samples in-house and published the resulting data jointly. CGI will use the same samples for additional collaborative studies involving the search for additional molecular biomarkers of CLL.

Georgia Health Sciences University

CGI entered into a research collaboration agreement for the development of molecular testing to facilitate diagnosis, prognosis and management of DLBCL patients. The specimens provided by the investigators will be used for ABC-GCB subtype classification by immunohistochemistry to identify and further validate genomic biomarkers for DLBCL using CGI’s proprietary MatBA®-DLBCL array. CGI also entered into a biological material transfer agreement for the validation of CGI’s proprietary FHACT™ probe in the diagnosis and disease management of head and neck cancers.

Stanford University

Stanford University recently granted CGI a worldwide, non-exclusive license under U.S. Patent No. 7,622,253 and U.S. Patent No. 7,332,280 directed to a method and an assay for the classification of diffuse large B-cell lymphoma (DLBCL) patients based on risk stratification and a predictive model for patient survival. The licensed technology analyzes the expression of six genes by a real-time PCR methodology in conjunction with an algorithm. The test is being commercialized by CGI Laboratories as SETRAâ„¢, Six gene Expression Treatment Response Assay.

University of Iowa Cancer Center

CGI entered into a material transfer agreement with the University of Iowa Research Foundation, whereby CGI received specimens useful to studies evaluating the FHACT™ assay in cervical liquid biopsy specimens. Study data is analyzed jointly. CGI also entered into a biological transfer agreement with the University of Iowa for the development and validation of molecular tests, such as MatBA®-DLBCL, to improve the diagnosis, prognosis and management of diffuse large B-cell lymphoma (DLBCL).

Memorial Sloan-Kettering Cancer Center

Multiple research collaborations have been formed with MSKCC with focuses in kidney cancer, chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL).

MSKCC provided CGI with a multitude of lymphoma specimens of varying histologies with known clinical outcomes for the and clinical validations of MatBA® for CLL, DLBCL, MCL and FL. CGI also received cores of FFPE tumor material spear-heading and providing justification for the use of this tissue type in array-CGH.

A biological material transfer agreement allowed the evaluation the first application of CGI’s proprietary array-CGH product line, UroGenRA™, in the diagnosis and subtyping of renal mass aspirates/core biopsies. The specimens were also used to compare UroGenRA™ with routine pathology testing.

Georgia Health Sciences University

CGI entered into a research collaboration agreement for the development of molecular testing to facilitate diagnosis, prognosis and management of DLBCL patients. The specimens provided by the investigators will be used for ABC-GCB subtype classification by immunohistochemistry to identify and further validate genomic biomarkers for DLBCL using CGI’s proprietary MatBA®-DLBCL array. CGI also entered into a biological material transfer agreement for the validation of CGI’s proprietary FHACT™ probe in the diagnosis and disease management of head and neck cancers.

Kamineni Hospital

This focus of this collaboration is to evaluate FHACT™, CGI’s proprietary FISH-based HPV-Associated Cancer Test, as a screening tool for the identification of pre-cancerous and cancerous cervical cells. CGI provides the FHACT™ DNA-FISH probe to the collaborating doctor’s laboratory where the assay is performed on Pap smears obtained during routine health visits. The data from this collaboration is analyzed jointly and publications will be jointly produced.

National Cancer Institute

The collaboration with NCI was formed to interrogate the potential role of identification of host genomic abnormalities by FISH (Fluorescence in situ hybridization) as a screening tool for the detection of HPV-associated pre-cancerous cells and cancerous cells. NCI provided liquid biopsy specimens for analysis by FHACT™, CGI’s proprietary FISH-based HPV-Associated Cancer Test. The NCI also provided anal liquid biopsy specimens that will be used for the evaluation of FHACT™ in anal cancer.

University of Iowa Cancer Center

CGI entered into a material transfer agreement with the University of Iowa Research Foundation, whereby CGI received specimens useful to studies evaluating the FHACT™ assay in cervical liquid biopsy specimens. Study data is analyzed jointly. CGI also entered into a biological transfer agreement with the University of Iowa for the development and validation of molecular tests, such as MatBA®-DLBCL, to improve the diagnosis, prognosis and management of diffuse large B-cell lymphoma (DLBCL).

Cleveland Clinic

CGI entered into a collaborative research agreement and non-exclusive license arrangement with Cleveland Clinic to start development around a renal cell carcinoma diagnostic focused on validating genomic biomarkers from DNA. CGI received numerous clinical specimens from the Cleveland Clinic and associated clinical and laboratory data was used for the validation of CGI’s proprietary microarray, UroGenRA™–Kidney. Samples were analyzed in CGI’s clinical laboratory and resulting data will be published jointly.

Memorial Sloan-Kettering Cancer Center

Multiple research collaborations have been formed with MSKCC with focuses in kidney cancer, chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL).

MSKCC provided CGI with a multitude of lymphoma specimens of varying histologies with known clinical outcomes for the and clinical validations of MatBA® for CLL, DLBCL, MCL and FL. CGI also received cores of FFPE tumor material spear-heading and providing justification for the use of this tissue type in array-CGH.

A biological material transfer agreement allowed the evaluation the first application of CGI’s proprietary array-CGH product line, UroGenRA™, in the diagnosis and subtyping of renal mass aspirates/core biopsies. The specimens were also used to compare UroGenRA™ with routine pathology testing.

Memorial Sloan-Kettering Cancer Center

Multiple research collaborations have been formed with MSKCC with focuses in kidney cancer, chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL).

MSKCC provided CGI with a multitude of lymphoma specimens of varying histologies with known clinical outcomes for the and clinical validations of MatBA® for CLL, DLBCL, MCL and FL. CGI also received cores of FFPE tumor material spear-heading and providing justification for the use of this tissue type in array-CGH.

A biological material transfer agreement allowed the evaluation the first application of CGI’s proprietary array-CGH product line, UroGenRA™, in the diagnosis and subtyping of renal mass aspirates/core biopsies. The specimens were also used to compare UroGenRA™ with routine pathology testing.

Mayo Clinic

CGI and Mayo Clinic launched a joint venture, OncoSpire Genomics. The objectives of this venture are to try to discover and validate biomarkers in specific hematologic and urogenital disorders utilizing next-generation sequencing with a possible expansion into other solid tumors, such as esophageal, head and neck, breast and lung cancers. Additionally, the joint venture entity would engage in biomarker discovery utilizing Mayo’s next-generation sequencing facility and the development of commercial products in the form of diagnostic products and services, as well as early stage therapeutic markers.