[November 10, 2015]

Proprietary Finger-Stick Cancer Monitoring Technology Launches Circulogene Theranostics into Liquid Biopsy Market

Circulogene Theranostics has announced the commercial launch of its cell-free DNA (cfDNA) liquid biopsy products for the fast, accurate and personalized testing of 10 tumor types, including breast, lung and colon cancer. Circulogene becomes the first and only biotechnology company able to enrich circulating cfDNA from a single blood drop for patient-specific monitoring of cancer.

Cell-free DNA comes from tumor cells that break open and release small pieces of DNA into the bloodstream.

"As soon as a patient receives a positive diagnosis of cancer from his or her physician, our test provides a rapid and cost effective tool to aid the physician in planning, implementing and monitoring the treatment process," said Circulogene CEO Mike Mullen. "Research has shown cancers change rapidly and shed tumor DNA into circulating blood. Our technology detects and monitors tumor changes in a very specific and sensitive way. This allows us to report to physicians in just days to aid them in selecting the right therapy for the right patient at the right time."

The result is potentially the most precise, rapid and cost-effective monitoring and targeted treatment of cancer possible. Newly published clinical research demonstrates the company's proprietary method can collect more than 100 times more cfDNA with just 1/10 of the blood (as little as 20 microliters) compared to the current industry standard for non-invasive liquid biopsy testing. Circulogene's proprietary technology is capable of detecting nearly 3000 cancer mutations on 50 well-established cancer-associated genes for its 10 cancer profiles.

Non-invasive liquid biopsies represent a major advance over traditional surgical tumor biopsies, which are costly, time consuming and only sample a small porion of tumor tissue, leading to a high failure rate. However, current industry-standard liquid biopsy methods require large sample amounts and could miss critical tumor information that can significantly change a patient's treatment and prognosis.

"Our science team is pioneering the next generation of liquid biopsy cancer management: tumor monitoring from droplet volumes of blood. No one else is doing that," said Circulogene Chief Scientific Officer Chen-Hsiung Yeh. "Our proprietary DNA enrichment method results in near-full recovery of cfDNA with just 20 to 50 microliters of blood. No venipuncture is required, and when combined with next-generation genomic sequencing, we have an unprecedented laboratory diagnostic test platform for improving cancer management."

In addition to providing the most accurate, actionable information, the company's proprietary cfDNA enrichment method delivers highly cost-effective genetic results from a single drop of various body fluids, including blood, in as little as seven days instead of weeks or months. With this major technological advance, Mullen shares the industry's belief that tumor genome sequencing of circulating cfDNA to manage cancer treatment can potentially become an important component of the standard of care.

"We've assembled a highly experienced and credentialed diagnostic team around a much-needed technology," said Mullen. "Similar to how diabetics monitor glucose levels, our test can accurately identify established genetic tumor mutations, drug resistance and remission in diagnosed cancer patients using a simple finger stick and drops of blood. This allows oncologists to use current FDA-approved and NCCN/ASCO-endorsed treatment options to respond to these changes at a fraction of the cost of standard liquid biopsy testing."

Circulogene will initially provide testing for the following cancers: breast, colorectal, lung, gastric, gastrointestinal stromal (GIST), hematological, melanoma, ovarian, pancreatic and thyroid. The company is currently partnering with researchers across the country to conduct further clinical trials at leading biotechnology research universities and exploring partnership opportunities.

Circulogene is Clinical Laboratory Improvement Amendments (CLIA) certified, and it plans to expand research initiatives to independently demonstrate greatly increased sensitivity and specificity compared to current methods. For more information, visit our website, connect with us on LinkedIn, email us at [email protected] or call 205-278-1600. Clinicians interested in ordering the test may visit the Contact page on Circulogene's website.

About Circulogene Theranostics

Headquartered in Birmingham, Ala., Circulogene Theranostics is an innovative molecular diagnostics company founded and operated by a team of experienced industry executives and skilled molecular diagnostics scientists. Applying its proprietary laboratory developed test for cfDNA liquid biopsies, Circulogene has developed the first droplet-volume, next-generation sequencing (NGS) method to provide full genomic load analysis, enabling more accurate data to help clinicians and their patients. For more information, visit www.circulogene.com or call 205-278-1600.

View source version on businesswire.com: http://www.businesswire.com/news/home/20151110006389/en/

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