Clinical Genomics Announces Closing of $15 Million Series A Financing Round

Investment will support commercialization of company’s blood-based test 
for colorectal cancer recurrence

Appoints Dr. Paul Kelly to board of directors

EDISON, N.J., March 23, 2016 (GLOBE NEWSWIRE) — Clinical Genomics, a private company developing next-generation diagnostic tools for colorectal cancer, today announced it closed a $15 million Series A financing round. The funding will be used to advance commercialization of the Company’s two-gene blood test for post-surgical monitoring of colorectal cancer recurrence.

The financing is being led by OneVentures, a venture capital firm headquartered in Sydney, Australia that provides human and investment capital into high growth technology companies with a presence in Australia and the U.S.

“This financing, our first institutional capital raise, will provide critical resources to support the commercialization of our patent-pending, 2-gene, blood-based assay for colorectal cancer surveillance,” said Dr. Lawrence LaPointe, President and CEO of Clinical Genomics. “Clinical data show that our test is approximately 2.5 times more sensitive than the current guidelines-recommended standard periodic blood test, and we are optimistic that our liquid biopsy technology has the potential to address an unmet need in colorectal cancer recurrence monitoring.”

In connection with the financing, Dr. Paul Kelly, Partner and Managing Director of OneVentures, will join Clinical Genomics’ board of directors.

“Clinical Genomics has a proven track record in bringing novel clinical diagnostics to market and is uniquely positioned to transform the paradigm of colorectal cancer surveillance with its minimally invasive two-gene blood test,” noted Dr. Kelly. “Our investment in the company underscores our confidence in the senior leadership team and we look forward to working together to advance the company’s mission to develop clinically proven products that improve patient outcomes and save lives.”

Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths worldwide, accounting for more than 600,000 deaths each year. When diagnosed early, before cancer has spread, the relative five-year survival rate for CRC is 90 percent, but only about four out of 10 CRC cases are detected early. Among individuals undergoing surgical treatment for CRC, 30 to 40 percent of all cases recur, the majority of which present in the first two to three years following initial diagnosis and treatment. This early and concentrated pattern is relatively unusual among cancers, and offers the opportunity for structured surveillance to detect signs of recurrence.

One element of the standard of care for post-surgical monitoring for CRC recurrence, quarterly or semi-annual blood-based testing to measure carcinoembryonic antigen (CEA) levels, has poor sensitivity and specificity (statistical measures that indicate the definitive presence or absence of cancer). To address the need for more accurate oncology monitoring tools, Clinical Genomics has developed a new blood test to detect tumor-specific methylated DNA biomarkers that leak from active lesions into the circulatory system. Current data suggest that a genomic test specific for these biomarkers is more sensitive than CEA testing and highly specific.

About Clinical Genomics

Clinical Genomics is a privately held biotechnology company developing innovative products for colorectal cancer diagnosis. With a broad intellectual property portfolio consisting of more than 20 issued and pending patents, Clinical Genomics has developed a sensitive and specific blood test for colorectal cancer based on methylated DNA from two genes, BCAT1 and IKZF1, and plans to offer this 2-gene test for CRC recurrence monitoring in the U.S. beginning later in 2016. Clinical Genomics, via its wholly-owned subsidiary Enterix Inc., currently offers the user-friendly, patient-preferred colorectal cancer screening InSure® FIT™ assay, a fecal immunochemical test that detects blood in the stool. InSure is also marketed in Australia and other countries (as ColoVantage Home).

Clinical Genomics has offices and laboratories in Bridgewater and Edison, New Jersey and Sydney, Australia, and operates as an FDA-registered and TGA-licensed manufacturer and a NATA-accredited laboratory.

CONTACT: Media Contact:
Danielle Lewis
Lazar Partners for Clinical Genomics
(212) 843-0211 or (917) 907-4239