Under Richard Ding's direction, bioTheranostics focuses on biomarkers to aid in cancer treatment
Richard Ding
CEO
Professional
CEO of bioTheranostics since September 2008, when corporate investor bioMérieux established the company; prior to joining bioTheranostics, was Senior VP for Strategy and Business Development at bioMérieux; held various cross-functional positions at Eli Lilly and Company and Myriad Genetics
Education
MBA from the University of Utah; undergraduate and scientific training at Fudan University in China
Personal
I serve on the Board of Directors of ImaginAb, an in vivo imaging company, and CombiMatrix, a molecular diagnostic lab.
bioTheranostics discovers, develops, and commercializes diagnostic tests that support personalized treatment of patients with cancer. We have a unique expertise in extracting genomic information from scanty tissues and translating the breakthrough science into clinical success.Personalized medicine is multifaceted—we focus on integrating diagnostics with disease management, and try to be a partner to physicians, especially those dealing with the most difficult to diagnose and treat cancers such as metastatic cancer. We process a range of proprietary molecular diagnostic tests at our CLIA-certified lab in San Diego.
The company provides comprehensive solutions for metastatic cancer. Our molecular diagnostic tests are real-time PCR-based assays that are compatible with readily available formalin-fixed paraffin embedded needle core biopsies, excisional biopsies and/or surgical samples.
Our first test, the CancerTYPE ID® molecular cancer classifier, predicts the tumor type in patients with metastatic cancers of unknown or uncertain origin. Diagnostic certainty for tumor classification is essential for selection of site-specific chemotherapy, appropriate biomarker testing, and effectiveness of molecular targeted treatments. CancerTYPE ID has shown its value in accurately diagnosing metastatic tumors—by far the most difficult-to-diagnose cancers. A recently published prospective study demonstrated that using site-directed therapies based on CancerTYPE ID diagnosis resulted in a survival benefit, a holy grail in terms of clinical evidence for novel molecular diagnostics.
Our second product is our PRÉCIS® Precision Medicine biomarker profiles for non-small cell lung, colorectal, breast, GIST, melanoma, and gastric cancers. PRÉCIS includes response and resistance biomarkers to help oncologists predict treatment response and evaluate underlying disease pathways as they consider targeted therapies. These biomarkers are actionable and supported by strong clinical evidence. Precision medicine requires both accurate diagnosis of cancer of origin and precise information about tumor pathways. With our industry-leading molecular classifier CancerTYPE ID and comprehensive and actionable PRÉCIS tumor biomarkers, bioTheranostics is at the forefront of personalized medicine for metastatic cancers.
Our third product is our Breast Cancer IndexSM, which quantifies the risk of recurrence of estrogen-receptor positive, lymph-node negative breast cancer. In the United States, we have done a good job on surveillance, and 70% to 80% of breast cancer patients are diagnosed in the early stages—stages I and II. But for many patients and physicians, questions remain about treatment and the benefits of chemotherapy. Unlike first-generation biomarkers that predict the risk of early distant recurrence (1 to 5 years), Breast Cancer Index accurately predicts both early and late (5 to 10 years) distant recurrence and guides extended endocrine therapy in appropriate patient populations. A study demonstrating this superior performance was recently presented at the San Antonio Breast Cancer Symposium.
Breast cancer is not a five-year disease. Meta-analyses have shown that more than half of all breast cancer recurrence and deaths occur after five years for early-stage breast cancer treated with adjuvant tamoxifen. Breast Cancer Index represents a new generation of biomarkers that provide comprehensive information for disease management—it is the only test that allows the assessment of a breast cancer patient’s risk of both early and late distant recurrence.
Our products make an impact on patients every day. For example, we had a situation where a patient was essentially in hospice with a cancer of unknown primary. CancerTYPE ID identified its origin as germline cancer, a very treatable disease. With the right diagnosis and the right therapy, the patient recovered fully and has been living a healthy life.
R&D work will continue for bioTheranostics. One area of focus is to continue to improve the analytical performance; another area is to demonstrate clinical utility. We have completed clinical studies and published results to illustrate our tests’ superior performance over standards of care. We are finalizing health economics studies for CancerTYPE ID and Breast Cancer Index and working with payers to drive general adoption. What is very important is our partnership with all stakeholders—oncologists, pathologists, hospital labs, and others—to ensure that these innovations are available to all appropriate patients.
Recent studies have demonstrated the effectiveness of CancerTYPE ID. 2012 was a pivotal year for bioTheranostics in that we were able to complete and publish a number of key studies supporting the use of our molecular tests. A four-year prospective trial conducted at the Sarah Cannon Research Institute found that CancerTYPE ID successfully predicted the site of origin in patients with cancer of unknown primary (CUP), helping to direct site-specific therapy and improve survival. This was the first-ever prospective evaluation of molecular tumor profiling in the clinical management of CUP. It was published in October in the Journal of Clinical Oncology. A second study, published in the Journal of Molecular Diagnostics, showed that CancerTYPE ID is more accurate than the standard of care in diagnosing metastatic tumors. The study was conducted in collaboration with the City of Hope National Medical Center and found that in a difficult to diagnose, high-grade metastatic cancer cohort, CancerTYPE ID demonstrated a 10% absolute accuracy improvement over immunohistochemistry. These results support the use of CancerTYPE ID as a standardized diagnostic aid when the primary tumor site is uncertain. They also reflect our ongoing commitment to pursuing clinical studies to demonstrate the clinical validity and utility of our tests, which is a novel concept in the diagnostic community. I really think we have helped to reshape the landscape in this regard.
Directions the company is considering in core areas of expertise. As targeted therapies become more prevalent and personalized medicine more of a reality, we see great opportunity for bioTheranostics to stay at the cutting edge of this emerging field. While we continue to drive clinical adoption of our proprietary tests, we also embrace novel technologies, such as sequencing, to deliver lab results reliably and efficiently. Our primary focus continues to be biomarkers that have proven clinical utility and can impact the standard of care.
