LabCorp annonce le lancement du test Epi proColon® pour le dépistage du cancer colorectal (2024)

First FDA-Approved Blood-Based Colorectal Cancer Test Offers Alternative for Patients Non-Compliant with Existing Screening Options

BURLINGTON, N.C.--(BUSINESS WIRE)--May 9, 2016-- Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced the launch of Epi proColon®, a blood-based test for colorectal cancer screening that was approved on April 13, 2016 for clinical use by the U.S. Food and Drug Administration (FDA). Epi proColon® is the first FDA-approved DNA based blood test for colorectal cancer. The test was developed by Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) and is available under a joint commercialization agreement with Polymedco, Inc. in North America. LabCorp, the world’s leading healthcare diagnostics company, is the first laboratory in the U.S. to offer this FDA-approved, blood-based colorectal cancer screening test.

“Colorectal cancer is one of the most curable diseases when detected in its early stages and treated surgically,” said Dr. Mark Brecher, chief medical officer for LabCorp Diagnostics. “Many people are not properly screened because they are reluctant to collect a stool sample or undergo a colonoscopy. Tested from a simple blood draw,Epi proColon® is a convenient, accurate alternative for those patients who should be screened for colorectal cancer. LabCorp is committed to delivering world-class diagnostics, and Epi proColon® will contribute to our mission to improve health and improve lives."

The Epi proColon® test detects Epigenomics proprietary Septin9 DNA methylation biomarker for colorectal cancer in cell-free DNA circulating in blood, which has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of colorectal cancer. The test is available immediately from LabCorp. Epi proColon® is an important addition to LabCorp’s leading menu of integrated testing that includes comprehensive colorectal cancer offerings.

According to the American Cancer Society, there are projected to be over 134 000 new diagnoses of colorectal cancer, and almost 50 000 deaths from colorectal cancer in the U.S. in 2016. Approximately 23 million people in the U.S. are identified as at-risk for colorectal cancer or meet guidelines to be screened for this cancer remain unscreened. Currently, approved screening options including stool testing and colonoscopy are often viewed as inconvenient, uncomfortable or unpleasant, and about 35% of eligible U.S. patients refuse to undergo them. For these people and their physicians, a convenient blood test that only requires a blood draw provides a powerful screening option designed to improve participation in screening and can support earlier cancer detection, resulting in improved outcomes. For patients who may be reluctant to complete stool testing or colonoscopy, Epi proColon® provides an alternative that can change the way care is provided and may encourage more patients to obtain recommended screenings.

Epi proColon® is a registered trademark of Epigenomics AG.

About LabCorp®

Laboratory Corporation of America® Holdings, an S&P 500 company, is the world's leading healthcare diagnostics company, providing comprehensive clinical laboratory services through LabCorp Diagnostics, and end-to-end drug development support through Covance Drug Development. LabCorp is a pioneer in commercializing new diagnostic technologies and is improving people's health by delivering the combination of world-class diagnostics, drug development services and technology-enabled solutions. With net revenue in excess of 8,5 $ billion in 2015 and more than 50 000 employees in approximately 60 countries, LabCorp offers innovative solutions to healthcare stakeholders. LabCorp clients include physicians, patients and consumers, biopharmaceutical companies, government agencies, managed care organizations, hospitals, and clinical labs. To learn more about Covance Drug Development, visit www.covance.com. To learn more about LabCorp and LabCorp Diagnostics, visit www.labcorp.com.

About Polymedco

Since 1980, Polymedco has evolved into a leading manufacturer, marketer, and distributor in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits that are specialized in hematology and cancer screening. The Company is a world leader in non-invasive colorectal cancer screening technology.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The Company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics' lead product, Epi proColon®, is a blood-based screening test for the early detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries. For more information, visit www.epigenomics.com.

LabCorp Legal Disclaimer

This press release contains forward-looking statements including with respect to estimated 2016 guidance and the impact of various factors on operating results. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace, adverse actions of governmental and other third-party payers and the results from the Company’s acquisition of Covance. Actual results could differ materially from those suggested by these forward-looking statements. Further information on potential factors that could affect LabCorp’s operating and financial results is included in the Company’s Form 10-K for the year ended December 31, 2015, and subsequent Forms 10-Q, including in each case under the heading risk factors, and in the Company’s other filings with the SEC, as well as in the risk factors included in Covance’s filings with the SEC. The information in this press release should be read in conjunction with a review of the Company’s filings with the SEC including the information in the Company’s Form 10-K for the year ended December 31, 2015, and subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Epigenomics Legal Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

LabCorp annonce le lancement du test Epi proColon® pour le dépistage du cancer colorectal (1)

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Source: Laboratory Corporation of America(R) Holdings

Laboratory Corporation of America® Holdings
Paul Surdez (investors), +1 336-436-5076 [emailprotected]
or
Pattie Kushner (media), +1 336-436-8263, [emailprotected]
www.labcorp.com

LabCorp annonce le lancement du test Epi proColon® pour le dépistage du cancer colorectal (2024)

FAQs

What lab results indicate colon cancer? ›

The most common tumor marker for colorectal cancer is the carcinoembryonic antigen (CEA). Blood tests for this tumor marker can sometimes suggest someone might have colorectal cancer, but they can't be used alone to screen for or diagnose cancer.

What lab marker is colon cancer? ›

Tumor marker tests are used to check for two substances in the blood that colorectal cancer may produce: carcinoembryonic antigen (CEA) and CA 19-9. The tests may help determine an appropriate course of treatment and, sometimes, whether the disease is likely to recur.

Does colon cancer show up in urine test? ›

Researchers have also identified small molecules, called metabolites, in urine that may signal the presence of colorectal polyps and tumors (27, 28).

What is the blood test for bowel cancer tumor marker? ›

CEA blood test

The most common tumour marker for bowel cancer is called carcinoembryonic antigen (CEA). If the results of the blood test show that you have a high CEA level, your doctor may organise more tests. This is because other factors, such as smoking or pregnancy, may also increase the level of CEA.

Can your blood work be normal and still have cancer? ›

For many tests, it is possible to have normal results even if you have cancer. And it is possible to have test results outside the normal range even if you are healthy. These are some of the reasons why lab tests alone can't say for sure if you have cancer or any other disease.

Can stool tests detect colon cancer? ›

Stool DNA testing is used to screen for colon cancer in people with no symptoms. It also screens for growths of cells, called polyps, that could one day become cancer. The stool DNA test looks for DNA changes and small amounts of blood shed into the stool. These might come from colon cancer or colon polyps.

What are the three markers for breast cancer? ›

In breast cancer, testing for three biomarkers is routinely done on every tumor: estrogen receptor status, progesterone receptor status, and HER2 status. The results of these tests will be in your pathology report. There are two hormone receptors that every breast cancer will be tested for.

Where is colon cancer pain felt? ›

Many cases of colon cancer have no symptoms. If there are symptoms, the following may indicate colon cancer: Abdominal pain and tenderness in the lower abdomen.

Do you pee a lot with colon cancer? ›

Major changes in bodily functions can indicate colon cancer, prostate cancer or bladder cancer, among other cancers. Important signs to be aware of include persistent constipation or diarrhea; black or red blood in your stool; black, tarry stools; more frequent urination; and blood in your urine.

What is the new test for colon cancer? ›

Details from the colorectal cancer blood test study

The shield test detects colorectal cancer signals in blood DNA shed by tumors, something called circulating tumor DNA (ctDNA). That measurement is also used in liquid biopsy tests used in monitoring for cancer recurrence in people who have already had cancer.

What do cancer stools look like? ›

Pencil-thin stool is unusually long and thin, which can indicate there is a narrowing of the colon due to a cancerous tumor. Flat stool. Abnormally flattened or ribbon-like feces characterize flat stool. Tumors that change the shape of the colon or rectum can create this type of stool.

What cancers cause high calprotectin? ›

Calprotectin has also been found to be elevated in patients with colorectal cancer. In 814 patients at high risk for colorectal cancer, undergoing colonoscopy, faecal calprotectin was found to have a sensitivity for cancer of 74% and for adenoma of 43%.

How much do you bleed with colon cancer? ›

Most colon cancers bleed, usually slowly. The stool may be streaked or mixed with blood, but often the blood cannot be seen.

Is white blood cell count high with colon cancer? ›

There was no significant association between WBC and the risk of rectal cancer. Our findings demonstrate that an elevated WBC is associated with an increase in both the mor- tality and incidence rates of colon cancer. These results support our hypothesis that inflammation increases the risk of colon cancer.

What CBC blood test indicate cancer? ›

A CBC can detect some blood or immune system cancers like leukemia and lymphoma. But it can't detect solid organ cancers like lung, breast or colon cancers. It can tell your provider how your body responds to treatment and whether the cancer has spread to your bone marrow. Tumor marker blood tests.

What is the primary test for colon cancer? ›

Colonoscopy. Colonoscopy is a procedure to look inside the rectum and colon for polyps, abnormal areas, or cancer. A colonoscope is inserted through the rectum into the colon. A colonoscope is a thin, tube-like instrument with a light and a lens for viewing.

Is CA 125 elevated in colon cancer? ›

Cancer antigen-125 (CA-125) was initially believed to be a specific biomarker for ovarian cancer, but recently it has been found in sera of patients with gastric, colorectal, and pancreatic adenocarcinomas. The level of CA-125 is raised in greater proportion of CRC cases (13).

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