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Task Force Grants Broad Support For Colorectal Cancer Screening Tools

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Task Force Grants Broad Support For Colorectal Cancer Screening Tools

By David Filmore
Around The Industry

June 16 2016 6:00 PM

Executive Summary

The US Preventive Services Task Force said colorectal cancer screening is effective for those aged 50 to 75. It recognizes the potential for a range of methods, from standard colonoscopy to CT colonography, to blood and fecal DNA testing, to be used to increase screening rates. The recommendations could help drive coverage and adoption for several firms’ products.

The federal task force that serves as the primary arbiter of what screening tests should be performed by providers and covered by insurers gave a broad-based thumbs-up to various modes of colorectal screening.

The US Preventive Services Task Force on June 16 granted its strongest “A”-rated recommendation to routine colorectal cancer screening for everyone aged 50 to 75, remaining essentially neutral on the type of test used to perform the screening. While USPSTF’s prior 2008 policy specifically recommended colonoscopy, fecal immunochemical tests, fecal occult blood tests (FOBTs) and flexible sigmoidoscopy (combined with FOBTs), the new policy has a broader reach.

“Instead of emphasizing specific screening approaches, the USPSTF has instead chosen to highlight that there is convincing evidence that colorectal cancer screening substantially reduces deaths from the disease among adults aged 50 to 75 years, and that not enough adults in the United States are using this effective preventive intervention,” the task force said in its recommendations, posted on its website and in the Journal of the American Medical Association.

The USPSTF says it “acknowledges that there is no ‘one-size-fits-all’ approach to colorectal cancer screening, and seeks to provide clinicians and patients with the best possible evidence about the various screening methods.”

This approach could be a boon for several colorectal-cancer screening alternatives, including new fecal and blood DNA tests, and computed tomography (CT) colonography.

In particular, the USPSTF recommendations mention each of these options, including DNA-based fecal testing, offered by Exact Sciences Corp.‘s Cologuard and FDA-approved in 2014, and the first blood-based test approved for colorectal cancer screening, Epigenomics AG‘s Epi proColon SEPT9 DNA assay, approved earlier this year. (See “Epigenomics’ Epi proColon Blood Test Finally Makes The Grade With FDA” — “The Gray Sheet,” Apr. 13, 2016.)

Under federal regulation, private payers participating in insurance exchanges are required to cover services rated as “A” and “B” by USPSTF without cost-sharing. Medicare is not required to cover these services, but if decides to do so, it must cover “A”- or “B”-rated services without co-pays.

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USPSTF: No ‘One-Size-Fits-All’ Approach

The task force does not suggest all the screening methods are equal. It specifically details the benefits and harms of each, for instance, noting that evidence for CT colonography is limited to studies of its “test characteristics,” and that it comes with risks of over-diagnosis.

“The USPSTF acknowledges that there is no ‘one-size-fits-all’ approach to colorectal cancer screening and seeks to provide clinicians and patients with the best possible evidence about the various screening methods to enable informed, individual decision-making,” the recommendation states.

While the USPSTF recommendation does not guarantee Medicare coverage, it could make it more likely that CMS will reconsider its coverage policies for various colorectal cancer screening tests. The Medical Imaging & Technology Alliance says that is exactly what it would like to see happen.

For example, CT colonography potentially offers a less-invasive alternative to standard colonoscopy, but has struggled under a national Medicare non-coverage policy established in 2009. (See “Medicare Denies Coverage Of CT Colonography For Cancer Screening” — “The Gray Sheet,” May 18, 2009.)

“We hope this will encourage the Centers for Medicare & Medicaid Services to provide national coverage of CT colonography, granting more beneficiaries access to early detection and lifesaving treatment, and saving millions of lives,” said Patrick Hope, MITA’s executive director.

Epi proColon is also not yet covered by Medicare. The test, which was approved by FDA in the middle of USPSTF’s review, just qualified for inclusion in the recommendation report, according to USPSTF. “A single test characteristic study met the inclusion criteria for the systematic evidence review supporting this recommendation statement; it found the SEPT9 DNA test to have low sensitivity (48%) for detecting colorectal cancer.“

The firm says it expects the inclusion of the test in the report to expand adoption and coverage for the assay.

Epigenomics says the new recommendations recognize “the potential role of our novel blood-based test in colorectal cancer screening, especially in driving patient compliance in individuals who are reluctant to collect stool samples or undergo colonoscopy.”

“We continue to work multiple paths for CMS coverage,” Noel Doheny, CEO of Epigenomics’ US subsidiary, told The Gray Sheet.

Cologuard, meanwhile, is already covered by Medicare. But Exact Sciences CEO Kevin Conroy says the company is “pleased with the clarity of these recommendations and expect they will expand and promote utilization of Cologuard as an innovative colon cancer screening option.”

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Task force removes all ambiguity, doubt from final CRC guidelines

MedicalDeviceDailyTHURSDAY, JUNE 16, 2016                                                                        VOLUME 20, NO. 116

CRC SCREENING NOT ‘EXACT SCIENCE’

Task force removes all ambiguity, doubt from final CRC guidelines

By Amanda Pedersen, Senior Staff Writer

The best cancer test is the one patients actually take, a point the U.S. Preventive Services  Task  Force  (USPSTF)  appears to have paid particularly close attention to in its updated colorectal cancer (CRC) screening recommendations, which were published ahead of schedule Wednesday in the Journal of the American Medical Association, along with several evidence reports and editorials. The final version of the guidelines included a key difference from the draft version released last October because the task force declined to express a preference in screening method and instead offered a list of acceptable screening strategies, including CT colonography (virtual colonoscopy) and multi-targeted stool DNA tests.

This change in the recommendations is especially significant for Exact Sciences Corp., because the task force removed  terms from its draft version that caught the company off  guard last year by  describing its Cologuard    stool-based DNA test as an “alternative” method that might be useful in “select clinical circumstances.” That news plunged Exact’s shares (NASDAQ:EXAS) 46 percent to close at $9.98 the day the draft statement was published because it created ambiguity that likely would have affected insurance reimbursement of the test.

Not only did the task force edit the term “alternative” out of its final recommendations, the authors also addressed the concerns that the draft had raised last year. The task force recognized that “a sizable proportion of the eligible U.S. population is not taking advantage of this effective preventive health strategy” and noted that “there is no one-size-fits-all approach to colorectal cancer screening.”

The final version of the guidelines is intended to “provide clinicians and patients with the best possible evidence about the various screening methods to enable informed, individual decision making,” the authors wrote.

The revision also impacts CT colonography tests, which also were categorized as an alternative screening method  in the draft version. According to the task force,   nearly one-third of U.S. adults have never been screened for CRC and “offering choice” in screening strategies may increase uptake. The rest of the statement is largely as expected, with the task force continuing to recommend CRC screening for people between the ages of 50 and 75 (considered an “A” recommendation). The decision to screen older adults, between the ages of 76  to 85, should be individualized based on screening history and overall health status (a “C” recommendation), the task force  said.

There are several Kamagra tablets, jellies and other items that can help enhance weight loss if cheap viagra energyhealingforeveryone.com utilized correctly. A chain smoker may suffer from impotency after many years of smoking. energyhealingforeveryone.com cialis stores generic cialis canada We will make sure that you will get the exact solution if you are not getting the perfect recommendation of the physician. cialis order levitra Even though they may appear as though they have committed some kind of crime. Exact Sciences CEO Kevin Conroy said the final recommendations provide “an important level of clarity” that Cologuard should receive the benefits given to A-rated preventive services under the Affordable Care Act.”

The news sent the Madison, Wis.-based company’s shares up about 33 percent to $12.50 Wednesday, but the stock dropped back down and closed at  $9.33.

The recommendations also include the recently FDA-approved Epi Procolon assay, a liquid biopsy performed with a blood sample, from Berlin-based Epigenomics AG.

Durado Brookes, managing director of cancer control intervention, prevention and early detection for the American Cancer Society (ACS), pointed out that the recommendations are “very similar” to a 2008 joint guideline from the ACS,   a U.S. multi-society task force on CRC and American College of Radiology (ACR). “These guidelines reinforce the notion that with several test options, the best test is the one you get,” Brookes said.

The ACR also responded to the final recommendations on CRC screening and noted that, under the Affordable Care Act, private insurers are now required to fully cover (without a co-pay) all of these USPSTF-recognized CRC screening exams.

“A third of those who should be screened for colorectal cancer still choose not to be tested. Patients need more fully-covered screening options if we are going to reduce colorectal cancer deaths,” said William Thorwarth, CEO of the ACR. “Private insurers and Medicare should now fully cover virtual colonoscopy and the other USPSTF-recognized exams.”

The USPSTF said it reviewed evidence on the effectiveness of screening with colonoscopy, flexible sigmoidoscopy,CT colonography, the guaiac-based fecal occult blood test, the fecal immunochemical test, the multi-targeted stool DNA test and the methylated SEPT9 DNA  test.

The task force evaluated the tests in terms of reducing  the incidence of and mortality from colorectal cancer or all-cause mortality, the harms of these screening tests, and the test performance characteristics for detecting adenomatous polyps, advanced adenomas based  on size, or both, as well as colorectal cancer. The USPSTF also commissioned a comparative modeling study to provide information on optimal starting and stopping ages and screening intervals across the different available screening methods. //

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Maryland company creates method to determine if you really need a colonoscopy

Baltimore Business Journal

Maryland company creates method to determine if you really need a colonoscopy

http://www.bizjournals.com/baltimore/news/2016/05/12/maryland-company-creates-an-alternative-to-the.html#i1

May 12, 2016, 12:11pm EDT

Sarah Gantz

epigenomics

Germantown cancer diagnostics company Epigenomics has a solution to the “yuck factor” that deters millions of Americans from getting screened for colorectal cancer.

Epigenomics, an American and German diagnostics company, in April received approval from the U.S. Food and Drug Administration for its colorectal cancer blood test, Epi pro Colon, and has landed lab testing giant LabCorp as its first customer.

The test is a less invasive — and less gross – alternative to stool sample screening tests that tell people whether they need a colonoscopy, and is entering the market as federal regulators push to increase compliance among Americans who should be getting screened. The test isn’t a replacement for a colonoscopy, but is a yuck-free way to tell who should get one and, company leaders hope, will lead to more people getting screened and catching more cancer in its earliest stages.

About 62 percent of the roughly 90 million Americans who should get screened for colorectal cancer actually do. The Centers for Disease Control and Prevention wants to raise screening compliance to 80 percent by 2018.
Epi pro Colon is ready to hit the market after eight years of testing and regulatory approvals.
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The American-German diagnostic company has a joint commercialization agreement with Polymedco Inc., a leading national supplier of lab tests and supplies. The two are moving quickly to take advantage of the potentially lucrative market of squeamish patients.

“Our target is the noncompliant patient,” said Epigenomics CEO Noel Doheny.

The patient whose doctor tells him every year to go get a colonoscopy and who, every year, shrugs off the order.

Aside from the “yuck factor,” as Doheny described it, patients can be deterred from the procedure because they can’t take the time off from work. Access to a nearby doctor can be a barrier for rural patients.
Epigenomics’ blood test aims to eliminate those barriers.

The test can be ordered by doctors as part of a panel of other lab work.

When doctors write out a prescription to send you to the lab for blood work, they’ll check the boxes for sugar, cholesterol and then one more — colorectal cancer, Doheny said.

LabCorp is the first of many lab clients Epigenomics hopes to land. When the labs’ sales representatives go on visits to doctors’ offices, they’ll take a long pamphlets about Epigenomics’ blood test and try to persuade them to order it for patients who have time and again refused to get a colonoscopy or stool test.

Once the test starts to catch on among labs and doctors, Epigenomics will likely pursue a social media campaign to market directly to patients.