GeneAssess’s cancer program is directed at developing and commercializing novel high-value diagnostic tests that ultimately could lead to better patient outcomes through appropriate triage, earlier diagnosis, and optimal therapeutic selection.

Technology Platform

GeneAssess, Inc. is dedicated to developing its breakthrough discovery of the FRY tumor suppressor gene into predictive biomarkers of epithelial cell derived tumors including those of the breast, prostate, ovary lung and brain. The company will develop three technology platforms:

  1. GeneAssess has developed proprietary antibodies to FRY protein and demonstrated that levels of the FRY protein expressed in human breast tumor cells, especially in the nucleus, are associated with tumor histopathology, grade cancer biomarker, hormonal status and clinical outcomes of breast cancer. Planned studies will validate FRY expression as a biomarker of tumor progression and outcomes in breast and other epithelial tumors (carcinomas). In addition to selling the antibody for research purposes, GeneAssess will develop FDA- approved, CLIA certified tests for use in diagnostic laboratories.
  2. A targeted Next Generation Sequencing platform to assess the frequency of FRY mutations in high risk cancer families and populations. Once FRY mutations are associated with increased cancer risk, GeneAssess will offer CLIA-certified gene sequencing for physicians requesting and their patients.
  3. Gene Asses will collaborate with researchers conducting therapeutic clinical trails to determine if tumors with low levels of FRY expression and/or function respond preferentially to specific therapeutic agents. A long term goal is to develop targeted therapies for FRY negative carcinomas.

Value Proposition

GeneAssess will develop unique, proprietary tests for cancer progression and genetic risk, initially for breast cancer. However, research indicates that FRY expression is associated with the progression and poor outcomes of many other cancers, indicating that the tests may be applicable to all major cancer types. FRY based tests could become part of the standard diagnostic battery for a majority of cancer patients. Thus, any mechanistically-based therapies developed to target FRY signaling pathways would also be applicable to a wide variety of carcinomas.

Unmet Market Need

Breast cancers are now routinely assessed for expression of the Estrogen Receptor (ER), Progesterone Receptor (PR) and the HER2 Receptor to predict outcomes and response to therapy. There are about ~230,000 new cases of breast cancer each year. FRY could be a biomarker for many other types of cancers, increasing the number of tumors to be screened to more than 1 million per year. In addition, the BRCA 1 and 2 tumor suppressor genes account for about half of all familial breast cancers, indicating that FRY could account for a significant fraction. Moreover, the effects of germline FRY mutations would not be limited to breast cancer, dramatically increasing the target population for screening. There is also a significant need for targeted molecular therapies that can be used against many tumor types.

Market Opportunity

  1. In addition to selected histological biomarkers (ER, PR, HER2, p53, etc) the current market for molecularly-based breast cancer diagnosis and prognosis are dominated by platforms based on DNA microarrays (MammaPrint™) and RT-CR (OncoType Dx™), which cost between $3,000 and $4,200 per patient. The latter has been applied to over 190,000 patients since 2004. GeneAssess believes that the central role of the FRY gene in epithelial cell differentiation will yield results comparable to those assaying multiple genes. Moreover, the FRY-based testing would not be limited to breast cancer.
  2. With respect to tumor suppressor gene sequencing, Myriad charges~$3,000 per patient to sequences the BRCA genes at a cost of $3,000 per patient ($360,000 year). FRY sequencing could exceed this level because it could be relevant to many cancer types.
  3. In the age of precision cancer therapy, drugs or biological targeting specific mechanisms will have a limited target population. The possibility that therapies targeting FRY signaling pathways could be used in a wide variety of cancers raises the possibility of a mechanistically-based drug that could become a ‘blockbuster’ in the pharmaceutical setting.

Marketing Strategy

GeneAssess will enter a three pronged strategy: 1) continue with internal development of products for research, and 2) simultaneously validate the assays for clinical use through collaborations with clinical collaborators to obtain FDA approval. Once assays are validated and approved, CLIA-certification will be sought for production of diagnostic kits and services. 3) GeneAssess collaborate with pharmaceutical partners to screen drug libraries for candidates that target FRY signaling pathways.

Proof of Principle Studies

Proof of concept studies have already been performed in rats, human breast cancer cells and tissue microarrays. The company will validate these findings in clinically annotated tumors and perform blinded studies to determine the positive predictive value of each test.

Patent State

GeneAssess platforms are protected a broad patent in prosecution in the United States and international markets that include composition of matter for FRY related reagents required for development of tests and services.

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