Predictive Biosciences' vision is to become the leading provider of noninvasive diagnostics for the precise clinical management of cancer, initially focusing on cancer survivors.

Predictive Biosciences is a molecular diagnostics company headquartered in Lexington, MA. Launched in 2006 with a $10 million Series A financing, the company was jointly founded by leading healthcare investors, experienced entrepreneurs, and internationally-renowned scientists in the areas of tumor growth, tumor angiogenesis, and cancer markers. Predictive Biosciences possesses an extensive IP portfolio – including 18 issued and pending US patents – and deep in-house expertise in proteomics, diagnostics, oncology, and tumor biomarkers.

Leveraging its portfolio of patented biomarkers and clinical algorithms, Predictive Biosciences is pioneering novel diagnostic assays for informed cancer management™. Predictive seeks to significantly improve care and reduce healthcare costs for cancer patients by personalizing diagnostic workups and clinical interventions. The company's products will be Intervention Diagnostics™ -- using proprietary clinical algorithms to deliver results with exceptionally high negative predictive value (NPV) and positive predictive value (PPV). These assays will detect urinary biomarkers fundamentally associated with the physiological changes resulting from cancer development and progression.

The Opportunity – Cancer Management

Cancer is the second-leading cause of death in the United States – resulting in more than 500,000 deaths per year. The annual economic cost of cancer in the U.S. is over $200 billion, with nearly $80 billion spent on direct medical care. With improved therapeutics, an aging population, and earlier detection, cancer is becoming a manageable, chronic disease, with high costs associated with costly, invasive diagnostic methods for surveillance of high-risk populations or cancer survivors. In the U.S. today, there are over 13 million cancer survivors, representing 3.5% of the general population, requiring ongoing cancer surveillance. Predictive is initially focused on the growing cancer survivor population and the large number of symptomatic individuals undergoing clinical workups for cancer.

Today's approaches to screening, diagnosing, and monitoring cancer remain plagued by the inconsistency and lack of sensitivity, specificity, and more importantly, predictive value of diagnostic tests such as blood-based marker assays and mammographies. On the other hand, gold-standard methods such as biopsies, cystoscopies, and colonoscopies are uncomfortable, inconvenient, expensive, and may have associated morbidity. These invasive procedures are often performed unnecessarily.

There exists a tremendous need for highly accurate, convenient diagnostics to provide physicians with actionable information for personalized diagnostic follow-up and treatment plans – avoiding expensive, invasive procedures and increasing patient compliance and comfort. Predictive Biosciences is focused on this need by developing molecular diagnostic tests that complement the physician’s armamentarium of diagnostic tools, resulting in more effective utilization of gold-standard diagnostics and reduced costs of patient surveillance.

The Predictive Biosciences Solution – Intervention Diagnostics™

Predictive Biosciences’ non-invasive, urine-based diagnostic assays will employ patented clinical algorithms (i.e., ClDD, or Clinical Intervention Determining Diagnostic™) enabling physicians to reliably determine the presence or absence of cancer, so that additional follow-up may be accelerated (if cancer is detected) or avoided (if a patient is cancer-free). These Intervention Diagnostics™ Assays include:

• Triage Monitoring Assay™, enabling physicians to delay costly and/or invasive diagnostic procedures (i.e., cystoscopy, biopsy, colonoscopy) based on extremely high confidence in a negative result with high NPV, identifying a patient as cancer-free
• Interval Monitoring Assay™, for surveillance and early detection of cancer between standard follow-ups, where a positive result (with high PPV) would accelerate diagnostic procedures and/or treatment, and
• Stratification Assay™, which supports a physician’s decision to manage a symptomatic patient with: (a) no further follow-up, (b) standard follow-up exam, or (c) intensive diagnostic methodologies

Predictive Biosciences’ biomarkers are applicable across multiple types of epithelial cancer, and the company is initially focusing on diagnostic applications in bladder, breast, and colorectal cancer, which together comprise 5+ million cancer survivors.

Urinary Matrix Metalloproteinases (MMPs) and A Disintegrin And Metalloproteinases (ADAMs) as Cancer Biomarkers

Predictive Biosciences’ first tests – for cost-effective monitoring and personalized management of bladder cancer survivors – are based on the detection of proprietary urinary biomarkers, including matrix metalloproteinases (MMPs) and a disintegrin and metalloproteinases (ADAMs). MMPs are a family of zinc-dependent endopeptidases that have been shown to be key regulators of tumor growth and metastasis formation. They are important mediators of cancer progression through the degradation of the extracellular matrix (ECM) and subsequent invasion of cancer cells, leading to metastasis. More recently, ADAMs have also been shown to contribute to extracellular matrix degradation.

In 1998, Dr. Marsha Moses, one of Predictive Biosciences’ scientific co-founders, first demonstrated an increased incidence of MMPs in the urine of cancer patients, and further studies have associated urinary MMPs and ADAM12 with breast cancer. More recently, several publications have confirmed the elevation of MMP-2, MMP-9, and ADAM12 in the urine of bladder cancer patients, advancing the utility of these biomarkers as clinical tests to monitor for bladder cancer recurrence and disease-free status.