FDA approves blood test to screen for colon cancer
Guardant Health has received authorisation from the Food and Drug Administration to offer a blood test called Shield for the identification of colon cancer on Monday. The test is not designed to replace colonoscopies; however, the enthusiasm among doctors regarding the method is high as the low rate of second highest cancer death cause in the United States can be improved through the usage of this test.
Shield was previously used by doctors as a screening technique, and it cost $895 directly from the patient’s pocket. The involvement of the FDA greatly increases the likelihood of Medicare and other insurance companies covering the cost of the blood test because of higher availability for the patients.
Dr Arvind Dasari an associate professor in the department of gastrointestinal and medical oncology of the University of Texas MD Anderson Cancer Center said the approval is a welcome development.
However, he added that with this he noted that the following would take some time if there would be changes which would enable enhancement of screening and diminished mortality rate.
The estimated number of deaths due to the said disease this year alone is more or less over 53, 000, says the American Cancer Society.
A study carried out in March indicated that Shield was 83% effective in identifying the colorectal cancer. It operates on the basis of identifying the DNA that is shed by malignant tumors in the bloodstream.
It performs best in identifying more advanced cancer, because by that time the tumor sheds even more of that DNA. Shield detected only 13% of polyps earlier and in addition to this only detected large endoscopic villous adenomas.
It would have to be undertaken at least once every 3 years with the screening starting at age 45, the same as the age one begins to be recommended for colonoscopy.
That does not mean positive test equals diagnosis of the virus or its illness associate with it. Even if results are consistent with cancer, the patient would require colonoscopy, to enable doctors to see where tumor is and how spread.
As the discussions have showed, a positive Shield test has to be followed by a colonoscopy to ascertain that the ‘You’ person has an advanced lesion or colorectal cancer or, otherwise, that the results were false, said Robert Smith, the senior vice president of Early Cancer Detection Science at the American Cancer Society. This is the testimony of some participants: “A test like this is not complete if it’s positive and you have not had a colonoscopy. ”
This is the second CE-marked blood test for the early detection of colon cancer, the first being Epigenomics’ Epi proColon which received CE-mark in April 2016. Yet few people use it Smith said this is because accuracy is seen as an issue with the device. Another thing that MMS lacks is it is not funded by Medicare and other private insurances.
There has been a worrisome trend of colon cancer with cases that are emerging in those aged below 55 years with the rates of increase rising by 1% to 2% in the last one and half decade. Similarly, in the same period, both cases and deaths among the adult population of people between the ages of 60 and above have been falling as indicated by the American Cancer Society.
“What gets me especially though is that it can be prevented,”, a gastroenterologist Dr. William Grady who is based at Fred Hutchinson Cancer Center Seattle. The researcher also expressed enthusiasm noting that among the things that brings him joy is while performing colonoscopy he is able to remove polyps that if they are not removed turn into cancerous cells.
In fact, among all types of cancer, colorectal cancer is one of those that can be prevented with screening and the accuracy of colonoscopy can barely be paralleled. But screening rates are extraordinarily low. Approximately five out of six people eligible for a recommended screening have not had the test.
“The largest issues of colon cancer today are that there are segments of the population which are not getting screened at all. ” “Provided that it will make the number of the people to be screened to rise, then it will be very significant. ”
Speaking in the March study of the Shield test that he conducted, Grady admits that the least compliant as regards screening are the adults in their 40s and 50s.
‘These are people who are working, many of them have dependents, and I think there are various other life circumstances that will interfere with the ability to take care of themselves, he said.
colonoscopy is lengthy and people require a least one day off work since it consumes many hours. There is also an element of repletion and potentially of the slightly unpleasant, which is simply distasteful for many people. In the procedure a small camera is endoscopicly and surgically from the rectum to search for the cancers or future potential cancers.
That camera must have an open view of the colon. Thirty six hours prior to the colonoscopy, patients are required to consume a strong dose of laxatives. That is, they are relayant on the bathroom most of their times.
According to Electra Paskett, deputy director for population sciences and community outreach at the Ohio State University Comprehensive Cancer Center, there are individuals who prefer not to address issues concerning stool, and there are those who do not have a pleasant feeling with colonoscopy especially the preparation process. “For many a person, a blood test would be the most preferable mode. ”
Another option of screening for colon cancer entails tests that check the fecal occult blood that may indicate colon polyps or cancer. Some of the samples of the FIT-DNA tests include Cologuard which is very appropriate in diagnosing cancer though not very appropriate in diagnosing the early stages of cancer namely precancerous polyps.
John Gormly, 77, Newport Beach, California-based man, had never get through colonoscopy screening. The day his doctor presented him with the opportunity of the Shield blood test, he seized it.
“A day or so later, he called me and said ‘I don’t like the results at all,’ ‘I’m going to send you get a colonoscopy,’ Gormly said. ” “I only discovered I had stage 2 colon cancer. ” Fortunately, surgeons excised the tumor fully.
“Thank God I had taken that blood test,” Gormly said, when asked his feeling on the matter. “I never felt anything, never knew anything was wrong,” she said, adding that, “Short of that blood test, I don’t know how it would have turned out. ”