Exact Sciences, Mayo Clinic Researchers Identify Blood-Based DNA Biomarker Panel to Accurately Diagnose Hepatocellular Carcinoma

WASHINGTON, June 5, 2018 /PRNewswire/ -- Researchers at EXACT Sciences Corp. (Nasdaq: EXAS) and Mayo Clinic announced significant progress toward developing a panel of novel, blood-based, DNA biomarkers that could accurately detect hepatocellular carcinoma (HCC), the most common cancer that originates in the liver.1 The researchers detailed their findings during a presentation today at Digestive Disease Week, the world's largest gathering of gastroenterologists and scientists in the field.

The biomarker panel was shown to be 95 percent sensitive for detecting HCC across all stages. Sensitivity among patients with curable-stage disease was 91 percent. The panel has overall specificity of 93 percent, demonstrating its ability to discriminate between normal and diseased patients. Sensitivity and specificity are the most important statistical measures of a cancer detection test's performance.

"These results are further validation of our advanced DNA technology and our multi-biomarker approach for the detection of the deadliest forms of cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "We look forward to advancing this important research in early stage cancer with Mayo Clinic."

HCC accounts for nearly 90 percent of all liver cancers and is the fastest-growing cause of cancer-related death in the United States.1 Mayo Clinic experts predict that liver and bile duct cancers will be the third-leading cause of cancer deaths in the United States by 2030 due, in part, to the obesity epidemic.2,3

Individuals diagnosed with cirrhosis have the greatest risk of developing HCC, and it is recommended that they undergo ultrasound and blood monitoring every six to 12 months. The three-year survival rate for patients regularly surveilled is approximately 60 percent, compared to approximately 30 percent for those who don't undergo regular surveillance.4 When HCC is detected early and treated, patient survival rates improve significantly.1 Exact Sciences estimates that more than 3 million Americans are eligible for HCC surveillance.

"The potential of an accurate, non-invasive blood test that can identify early-stage disease is very exciting," said John Kisiel, M.D., the gastroenterologist and assistant professor of medicine at Mayo Clinic Medical School who led the study. "This could potentially transform the way patients are monitored and lead to the identification of many more curable-stage tumors than we typically see today."

Dr. Kisiel said the current options for monitoring at-risk patients are "sub-optimal."

"We estimate that fewer than half of at-risk patients are tested regularly, and some estimates suggest the monitoring rate is less than 20 percent in primary care settings, where most people get their care," Dr. Kisiel said.

Using DNA extracted from the blood samples of 244 people, including 95 diagnosed across all stages of HCC, 51 with cirrhosis, and 98 healthy volunteers, researchers tested the samples against 15 biomarkers to identify the combination of six biomarkers that yielded the most accurate detection of HCC.

"Now we must confirm the accuracy of the biomarkers we've studied for the detection of HCC," Dr. Kisiel said. "We are seeking to apply this DNA assay technology to all cancers, and these findings are an important step toward that goal."

Exact Sciences and Mayo Clinic have been collaborators since 2009. The collaboration previously yielded Cologuard, the stool-based, advanced-DNA screening test for colorectal cancer. The non-invasive test was approved by the U.S. Food and Drug Administration in 2014 and has been used by more than 1 million patients. Exact Sciences has identified biomarkers associated with 10 of the deadliest cancers and is advancing a pipeline of non-invasive diagnostic and screening tests based on those biomarkers.

The study results can be found at: https://www.sciencedirect.com/science/article/pii/S0016508518337041

About Hepatocellular Carcinoma (HCC)

Hepatocellular carcinoma (HCC) is the most commonly occurring form of liver cancer globally. More than half a million people are diagnosed with HCC each year.1 The primary risk factor for HCC is chronic liver disease, such as cirrhosis. It is recommended that people at high risk for HCC get screened every six to 12 months through a combination of ultrasound and alpha-fetoprotein (AFP) blood tests.1,4 -5 However, these current monitoring tests have limitations in accuracy and accessibility - liver ultrasound detects only 45 percent of early stage cancer.5 In the United States, nearly 42,000 people are diagnosed and more than 30,000 people die annually from liver cancer, which includes HCC and intrahepatic bile duct cancer.6

About Exact Sciences

Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.

1El-Serag HB & Davila JA. Surveillance for hepatocellular carcinoma: in whom and how? Ther Adv Gastroenterol (2011) 4(1): 5-10.
2 Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected Burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014;74(11): 2913-21.
3 Aleksandrova K, Stelmach-Mardas M, Schlesinger S. Obesity and liver cancer. Recent Results Cancer Res. 2016; 208: 177-198.
4 Kuo YH et al. Hepatocellular carcinoma surveillance and appropriate treatment options improve survival for patients with liver cirrhosis. Eur J Cancer (2010); 46(4): 744-51.
5 Tzartzeva K, Obi J, Rish NE, et al. Surveillance imaging and Alpha Fetoprotein for early detection of Hepatocellular Carcinoma in patients with cirrhosis: A meta-analysis. Gastro (2018); 154(6):1706-18.
6 American Cancer Society. Facts & Figures 2018. American Cancer Society. Atlanta, Ga. 2018.

Exact Sciences Corp
Contact: J.P. Fielder
+1 608-210-5220

Mayo Clinic
Contact: Joe Dangor
+1 507 266-0696


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