Exact Sciences Cologuard® test gets label expansion approval from FDA
Category: #health  By Pankaj Singh  Date: 2019-09-24
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Exact Sciences Cologuard® test gets label expansion approval from FDA

Colorectal cancer cases are increasingly growing across the world, however it is one of those cancers which can be treated if diagnosed at early stages. Various pharmaceutical and medical firms in the world are continuously working to find effective treatments and spread more awareness on colorectal cancer. 

Exact Sciences Corp., an American molecular diagnostics firm with a primary focus on early colorectal cancer detection and prevention, reportedly announced that Cologuard, its noninvasive colorectal cancer screening test gained the approval for label expansion from the U.S. Food and Drug Administration (FDA).

The Cologuard can now be used by a younger demographic; people with ages ranging from 45 to 49 years.

Kevin Conroy, CEO of Exact Sciences stated that it is good news for Americans aged between 45 to 49 years since the approval has extended the screening age five years earlier than before. Conroy further added that approximately 20 million Americans that need to screen themselves for colon cancer. 

Colorectal cancer is said to be the most preventable but least prevented type of cancer. Colorectal cancer is second most deadly form of cancer in the United States. General screening is critical since colorectal cancer can be better treated if detected in early stages.

Backed by robust science and strong clinical research in partnership with Mayo Clinic, Cologuard is a stool DNA-based colorectal cancer screening test conducted in individuals with average-risk. Cologuard utilizes a biomarker panel that analyzes stool sample of a person for 10 DNA markers, and blood in the stool is analyzed for hemoglobin.

In an effort to battle the gap of colorectal cancer screening, the company has built a one-of-a-kind, user-navigation system which can be used across the nation that offers 24/7 phone as well as online support to deliver help to people with the process of returning and collecting their samples. This method integrates several industry best practices to facilitate a vital tool in the combined efforts to boost colorectal cancer screening.

Exact Sciences is aimed to operate across health care delivery system in order to ensure that those who are seeking an at-home, noninvasive screening test get access to all of the options and is actively collaborating with payer partners to extend coverage in order to include this important screening population.

Source credit: https://www.foxbusiness.com/business-leaders/fda-approves-at-home



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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