The global molecular diagnostics market was valued at $527 million USD in 2013 and is expected to reach 1.5 billion USD by 2018. Metabolomics is one of the newer sciences in molecular diagnostics, and has the ability to accurately identify pre-disease state, providing a revolutionary preventative tool.

As the second leading cause of cancer-related deaths in the United States, and the third most common cancer worldwide, colorectal cancer (CRC) is a major public health concern. There is an urgent need for a more patient-friendly, accurate and inexpensive population-based screening test for CRC. The relative survival rate for colorectal cancer when diagnosed at an early stage is about 90%, however only about 40% of colorectal cancers are found at that early stage.

While the traditional diagnostics market is well-established and the channels to market entry are dominated by a few global players, the MDx market is rapidly evolving offering opportunities for new entrants. As such, there has been an explosion of new entrants in the market place creating new revenue streams to compliment traditional diagnostics. A new value chain is emerging in the industry that both precedes traditional diagnostics, as well as play a role downstream in developing and fine-tuning therapies as they are delivered to patients (see below figure).

PolypDx™ is uniquely positioned as the only urine-based test that detects precancerous, adenomatous polyps for the prevention of colorectal cancer and population-based screening.