Australian cancer-testing biotech secures AUD$33 million in new funding

Home grown success story drives the commercialisation of Colvera™, a liquid biopsy test for colorectal cancer (CRC) recurrence, and the focus of growing clinical evidence to support its use as the first widely adopted blood test for screening for colorectal cancer

Liquid biopsy tests identify DNA of tumor cancer cells in circulating blood.

New investors such as Moelis Australia Asset Management and Regal joined existing Clinical Genomics shareholders Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services and Sydney based Australian venture capital firm OneVentures in the new round of funding.

The company had raised more than AU$50M over the past two years with the majority of that coming from Australian investors.

Clinical Genomics has been helping to save lives through early detection of CRC for decades, pioneering the fecal immunochemical test (FIT). Clinical Genomics has continued to lead this field with the recent launch of the FDA-cleared InSure® ONE™ with collaborator Quest Diagnostics (NYSE: DGX), the world’s largest provider of diagnostic testing services. Quest provides access to InSure ONE to its physicians and patients in the United States.

In 2017, the U.S. Multi-Society Task Force on Colorectal Cancer concluded that “annual FIT is more effective and less costly than FIT-fecal DNA every 3 years so that the FIT-fecal DNA test is unlikely to replace FIT in large organized screening programs.” In the same year, a clinical study demonstrated that InSure FIT is statistically significantly more sensitive than certain other market leading tests for precancerous lesions.1

The profits from recent acceleration in growth for InSure will be combined with proceeds from this financing to build on Clinical Genomics’ leadership position in the estimated $1 billion colorectal cancer monitoring market, and the $10 billion market for blood-based colorectal cancer screening test.

“Strategic, selective investment in innovators such as Clinical Genomics is part of Quest’s accelerate growth strategy, particularly for advanced services such as genetics and oncology,” said Kristie M. Dolan, General Manager, Oncology, Quest Diagnostics. “Quest and Clinical Genomics have a track record of bringing advanced diagnostic service capabilities in colorectal cancer to physicians and patients. We believe Colvera, like InsureOne, has potential to enhance the early detection of colorectal cancer, serving a major clinical need that could improve patient outcomes.”

Clinical Genomics CEO Dr. Lawrence LaPointe says he has been greatly encouraged by the response so far from clinicians and people affected by colorectal cancer. “The reception we’ve had from clinicians and patients suggest terrific potential as we invest the capital raised to demonstrate the clinical and economic benefit of using liquid biopsy tests such as Colvera for both colorectal cancer monitoring and screening. Our team is driven by the opportunity to use our tests to save lives from this deadly disease worldwide.”

OneVentures played a key role in the financing by increasing their position in Clinical Genomics and enabling many of their limited partners to invest further. OneVentures Managing Partner and Clinical Genomics Director Paul Kelly MD said, “The company is poised to achieve some very significant milestones over the next couple years that should further drive revenue and value growth.”

Moelis Australia Advisory served as financial advisor.

Colvera, a blood test for CRC that was developed in collaboration with CSIRO and Flinders University, has been launched as a CLIA-developed lab service via the company’s CAP-accredited Bridgewater, NJ laboratory. The lab has secured licensing to provide testing services for patients in 48 US states. This test is being used to identify and to help treat recurrent CRC cases by improving on current guidelines based on carcinoembryonic antigen (CEA). Colvera may enable earlier detection of recurrent cancer than other methods, and has been shown to detect more than twice as many recurrent cancers as CEA2. Early detection and treatment increases the prospect of favorable outcomes.

About Clinical Genomics Clinical Genomics is dedicated to improving patient outcomes through early detection of colorectal cancer. Clinical Genomics products span the full spectrum of colorectal cancer testing, including InSure® FIT™, a fecal immunochemical test for screening in healthy adults, InSure® ONE™, a one sample FIT used to detect lower GI bleeding, and COLVERA™, a proprietary liquid biopsy blood test identifying circulating tumor DNA for detection of residual disease and early detection of recurrence in post-treatment patients. Clinical Genomics is committed to developing and delivering solutions that provide physicians and their patients with information to help guide earlier and better treatment decisions in cancer care management. Clinical Genomics continues to apply its proprietary innovation in molecular pathology to commercialize other diagnostic tools in other cancer types.

About OneVentures OneVentures is one of Australia’s leading venture capital firms, with over $320M in funds under management. But we do more than invest. We take companies to that all important next stage, by actively shaping their future. We apply our years of international experience, operational and executional expertise to accelerate the growth of our portfolio companies.

A global growth focus drives our investment selection with our current portfolio including companies with truly innovative products tackling multi-billion-dollar problems, from needle-free vaccinations to virtual communications to adaptive e-learning.

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[1] Shapiro JA, et al. A Comparison of Fecal Immunochemical and High-Sensitivity Guaiac Tests for Colorectal Cancer Screening. The American College of Gastroenterology 2017. doi: 10.1038/ajg.2017.285.

[2] Young GP, et al. A cross- sectional study comparing a blood test for methylated BCAT1 and IKZF1 tumor-derived DNA with CEA for detection of recurrent colorectal cancer. Cancer Medicine. 2016. doi: 10.1002/cam4.868.

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