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Blood Test for Colorectal Cancer: The Last Resort?

MEDSCAPE ONCOLOGY

Blood Test for Colorectal Cancer: The Last Resort?

http://www.medscape.com/viewarticle/868226

Roxanne Nelson, BSN, RN

August 31, 2016

Despite recommendations, many Americans in the target age group are not getting screened for colorectal cancer.

However, a new blood-based screening test may help boost those rates because of its simplicity and convenience for the patient.

The downside is that the new test is not as sensitive or accurate as a colonoscopy or the other recommended screening approaches.

Approved in April 2016, the Epi proColon (Epigenomics AG) is the first blood-based colorectal screening test to get a thumbs-up from the US Food and Drug Administration (FDA).

This molecular test detects methylated Septin 9 DNA in plasma, which is increased in colorectal cancer and can be found in tumor DNA that has been shed into the bloodstream from both colon and rectal sites. This makes it a differential biomarker for the early detection of colorectal cancer, according to the manufacturer.

Available in Europe since 2012, it is also being marketed in other countries, including China.

The question now facing healthcare providers is, Where does this new test fit in the current armamentarium of screening options?

“It’s the new kid on the block, another alternative, and one that isn’t as highly recommended as the current options that are available,” said Andrew Chan, MD, an associate professor of medicine at Harvard Medical School and a practicing gastroenterologist at Massachusetts General Hospital in Boston.

The major advantage of the Epi proColon is that because it is fast, easy, and noninvasive, it may appeal to individuals who have shunned other screening approaches.

“I believe that any screening test is better than no screening,” Dr Chan told Medscape Medical News. “But we also have to be cautious about using screening tests simply because they are easy to employ. Screening also involves a follow-up and a discussion of the results.”

What isn’t clear is whether the benefits outweigh the risks, he explained. “Or if there are tradeoffs, such as the test picking up false-positives or the consequence of false-negatives, which may give the patient an inappropriate sense of security.”

Basically, there are a lot of caveats with this test, and it shouldn’t be considered an easy alternative. “This blood test hasn’t been shown to reduce mortality from colon cancer, which is the most important data,” Dr Chan emphasized. “So we don’t know how it is going to compare to the other established screening tests.”

Need for More Options

Both the incidence of and mortality from colorectal cancer have been declining in recent years, and much of that is attributed to screening.

However, screening rates are well below the targets designated by public health agencies. According to National Health Interview Survey data, screening use overall was below the targets; there were no improvements from 2010 to 2013 for not only colorectal cancer screening but also for breast and cervical cancer.

But for colorectal cancer screening, after adjustments were made for age, 58.2% of survey respondents aged 50 to 75 years reported getting screened.

This rate falls short of the Healthy People 2020 target of 70.5% (2008 baseline, 52.1%). In addition, screening was lower among Asians and all Hispanic subgroups except Puerto Ricans, and younger individuals were less likely to be screened (50 to 64 years, 52.8%) compared with older persons (age 65 to 75 years, 69.4%).

“Anything that brings more people into screening is great,” commented David Johnson, MD, a past president of the American College of Gastroenterology (ACG) and coauthor of the ACG’s colorectal cancer screening guideline. But this new blood test “is not meant to replace any of the better tests that are available now, and that is the undercurrent message.”

The Epi proColon is primarily meant for people who have declined other types of screening, he told Medscape Medical News. “This is a test that only detects cancer, and the best test should be able to prevent cancer, and recognize precancerous polyps.”

The ultimate screening test should mitigate toward cancer prevention rather than detection, explained Dr Johnson, who is also professor of medicine and chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk.

Colonoscopy has been proven to decrease the incidence of colon cancer and prevent colon cancer-related death, and it remains the preferred strategy in the ACG’s guidelines, last published in 2009, he noted.

“It is the best test is to prevent cancer because it can detect polyps and in turn decreases mortality and colon cancer incidence,” he said. “For every 1% in adenoma detection rate, there was a 3% reduction in the incidence in colon cancer and a 4% reduction in death, and it comes down to polyp removal.”

All of this needs to be put into context in primary care, where most patients will most likely be counseled about screening. “In primary care, when patients ask about the Epi proColon, it should be put into context as to how it compares with other tests,” he said. “And importantly, that the test is just for cancer detection and will not detect precancerous polyps.”

The Centers for Disease Control and Prevention, in conjunction with other groups, has set a goal for a screening rate of 80% by 2018 in order to reduce colon cancer incidence and death rates.

“This test could help reach that goal,” Dr Johnson said. “But only if the patient has been appropriately counseled and refuses everything else, then this becomes an option. It is paramount that the provider puts it into perspective.”

Task Force Guidelines

In their updated 2016 guidelines, the US Preventive Services Task Force (USPSTF) found convincing evidence that colorectal cancer screening substantially reduces disease-related mortality, but it did not recommend any one screening approach over any other.

The USPSTF now recommends seven different screening strategies: colonoscopy, fecal immunochemical testing (FIT) for occult blood, guaiac-based fecal occult blood testing, sigmoidoscopy alone, sigmoidoscopy plus FIT, the FIT-DNA test, and computed tomographic colonography.

They all have varying levels of evidence supporting their effectiveness, and the potential harms also differ among the specific approaches.

Though it is sildenafil online without prescription a male hormone, there are significant amounts of it present in women too. Here are no prescription viagra a few traits of this world-class medication that have revitalized and rejuvenated their love-life. DOSAGE order discount viagra The dosage pattern is generally quite simple. In buy cialis viagra fact, it is wiser to consult your doctor first. Douglas Owens, MD, former Task Force member, general internist at the Veterans Affairs Palo Alto Health Care System, and professor at Stanford University in California, pointed out that the Epi ProColon test was included in the Task Force’s review.

“This screening method currently has limited published evidence evaluating its use,” he said. “It had a sensitivity to detect colorectal cancer of under 50%, which is quite low, as we would want sensitivity levels at about 90% or higher. Therefore, it was not included in the table on screening strategies in the final recommendation statement.”

Dr Owens emphasized that the FDA recommends that the blood test to detect methylated SEPT9 DNA be offered only to patients who have a history of not completing colorectal cancer screening.

“The FDA also recommends that the available tests included in the Task Force’s 2008 final recommendation be offered first,” he said. “The Task Force bases all of its recommendations on the best evidence that is currently available. As such, the tests with sufficient evidence were listed in the table.”

Efficacy of the Test

Two years before the FDA approved the blood test, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee reviewed the data. Even though the reception was not overly enthusiastic, they voted by a narrow margin to recommend premarket approval for the test.

Most of the panel agreed that the test was safe (yes, 9; abstain, 1).

But when it came to effectiveness, the panel was decidedly mixed (yes, 5; no, 6), as well as regarding whether its benefits outweigh its risks (yes, 5; no, 4; abstain, 1).

Data from two clinical studies were used in the decision making process.

The first study compared the efficacy of Epi proColon to colonoscopy in 1544 samples drawn from individuals aged 50 to 85 years who were at average risk for colorectal cancer.

The sensitivity of Epi proColon was 68.2% (95% confidence interval [CI], 53% – 80%) and specificity was 80% (95% CI, 77.9% – 82.1%). The negative predictive value was 99.7% (95% CI, 99.6% – 99.8%) and positive predictive value was 2.4% (95% CI, 2% – 3%).

The second study compared the accuracy of Epi proColon to FIT using matched blood and stool samples from 290 participants. Epi proColon was statistically noninferior to FIT with respect to sensitivity (72.2% for Epi proColon vs 68% for FIT) but not specificity (80.8% vs 97.4%).

The manufacturer does agree that the Epi proColon test is not meant to be a simple alternative to the other screening strategies — at least not at this time.

Instead, the company emphasizes that the test is indicated for people who are at average risk for colorectal cancer, are age 50 years and older, and have been offered and have a history of not completing screening by tests recommended in the 2008 USPSTF guidelines.

These recommended tests should be offered and declined before Epi proColon is offered as an option for screening, and specifically, the Epi proColon is not intended to replace screening tests recommended by appropriate guidelines, the company emphasizes.

“There are 23 million average risk people who are not getting screened,” said Noel Doheny, CEO of Epigenomics USA. “And those are the people we are targeting.”

The assumption was that people who were unwilling or unable to undergo screening with the recommended tests might do so if an easier option was available. “The third study we did is pending publication, and it answered the question for the FDA — would somebody who is noncompliant use a blood test,” he explained. “We recruited 413 patients who were twice noncompliant after being told by a physician to get either a colonoscopy or FIT, and 99.5% of those randomized to our test got a blood test on the spot.”

Of 203 individuals in the Epi proColon group, 202 had the test done. Of that group, 30 had a positive test result; of those, 17 individuals went on to have a colonoscopy, with 10 having a polyp removed.

In the FIT group, of the 210 participants who were offered the stool test, 185 completed it (88.1%). There were 3 positive results, and 1 person had a colonoscopy with a polyp removed.

“Participation is the key,” said Doheny. “If you can’t get someone tested, the specificity and sensitivity aren’t of any value. But by getting 99.5% tested, you can now answer those questions for those who were previously noncompliant.”

These are the only data available right now, but he explained that his company is currently in a dialog with the FDA about postapproval studies.

“We are planning trials that will confirm the adherence number and look at the test’s usage over a number of years,” he said.

In addition, there are also trials in place with high-risk patients, and a similar trial in lung cancer has been initiated.

Regarding insurance coverage, Doheny pointed out that the Epi proColon test was actually available for several years before its FDA approval.

“The test was developed over 4 years ago with the help of Quest Diagnostics and ARUP [Associated Regional and University Pathologists] as a laboratory developed test,” he said. “They configured it and offered it, and over the years, a majority of payers have been paying for it.”

“Since we received approval, the number of payers is now likely to be even higher,” Doheny added.

The test still has yet to be approved for insurance reimbursement by the Centers for Medicare & Medicaid Services (CMS), but the company is currently in discussions with CMS.

Dr Johnson disclosed that he has served as a director, officer, partner, employee, advisor, consultant, or trustee for Pfizer Inc, Epigenomics, WebMD, CRH Medical, and Medtronic and has received income in an amount equal to or greater than $250 from Pfizer Inc, Epigenomics, WebMD, CRH Medical, and Medtronic. Dr Chan reports consulting for Bayer Healthcare, Pfizer Inc, and Pozen Inc.

Follow Medscape Oncology on Twitter: @MedscapeOnc

 

Medscape Medical News © 2016  WebMD, LLC

Send comments and news tips to news@medscape.net.

Cite this article: Blood Test for Colorectal C

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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.

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Home grown version of Epigenomics colorectal blood test will soon to be available in China

MedicalDeviceDailyVOLUME 20, NO. 91
WEDNESDAY, MAY 11, 2016

SEPTIN9 LISTED AS INNOVATIVE PRODUCT
Home grown version of Epigenomics colorectal
blood test will soon to be available in China

By Cornelia Zou, Staff Writer

HONG KONG – Screening for some cancers using blood samples should soon be
easier for people in China. The market is now expecting a domestically produced
version of German diagnostic company Epigenomics AG’s colorectal cancer (CRC)
test.

The CRC blood test, Septin9, which Epigenomics co-developed with China’s Biochain Institute Inc. and its affiliate Biochain Beijing Science and Technology Corp., was listed as an innovative medical product in the CFDA’s 2015 medical device registration report. This means the product has significant clinical value and has Chinese patents granted or pending. Last year, the CFDA selected only 29 products out of 166 applications for fast registration approval.

On top of importing Epigenomics’ blood test for CRC, Biochain is developing a Chinese version of the test as well as filing the regulatory application of the product to the CFDA.

“The approval is effectively obtained by the local company Biochain. We did this deliberately because as a small foreign company we might have a very difficult time entering any markets we don’t understand very well,” Thomas Taapken, Epigenomics’ CEO told Medical Device Daily.

Lack of reimbursement in China, coupled with other market factors, have made it difficult to ramp up the company’s commercial ambitions in China, Taapken said.
Epigenomics’ products marketed in Europe and the United States are made with more expensive components from local vendors. Some of the underlying technologies are also protected by patents in these countries. But in China, Biochain
is able to source these components domestically at much lower prices and avoid paying import duties by manufacturing in country.
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“So we have a huge price advantage in China,” said Taapken. “They have the rights to develop the product in China and that is their basis for business going forward.”

Septin9, known as Epi Procolon outside of China, is a blood test based on the DNA methylation marker septin 9. The product detects the DNA methylation signatures in cancer cells that are not present in healthy cells to distinguish the diseased ones from the healthy ones. But what makes this product stand out, Taapken said, is it detects these signatures not only on a cellular level but also from easily accessible body fluids like blood.

“For another type of cancer it’s a different marker,” said Taapken. “We are really developing all this on a broad platform and we aim to grow that platform going forward.”

In 2013, Biochain and Epigenomics signed a license agreement for the development and commercialization of the septin 9-based CRC blood test in China. Biochain introduced Epigenomics’ existing product into the Chinese market as an imported medical device first while working on its own version.

The test was included in the Chinese Guideline on Screening, Endoscopic Diagnosis and Treatment of Early Colorectal Cancer, co-released by the Chinese Anti-cancer Association and Chinese Society of Digestive Endoscopy last summer. The guideline encourages the public to do regular check-ups for CRC for early detection and treatment to achieve lower mortality rate.

“CRC develops over a long period of time but you don’t have any symptoms, so you’re progressing without knowing you have the disease. When you know it’s too late for treatment,” said Taapken. “About 290 million people are currently eligible for
CRC screening in China. The guideline recommended either stool or blood test for CRC, this is the first time and a very clear move to establish a CRC screening program in China.”
The companies are working together on a blood test for lung cancer.Epigenomics is looking at high volume indications with unmet medical needs and no viable screening solutions on the market yet.

“We are taking one step at a time,” said Taapken. “These developments take a long time especially when you want to do regulatory studies for the U.S. for registration purpose.”

According to Taapken, the real bottleneck is the clinical validation required in the United States. “You have to generate data from relatively large prospectively collective clinical
studies, and those studies are not only time consuming, they are also very expensive to do.”

And because of the large amount of data acquired to get the product through regulatory process, so far, the Septin9 blood test has seen little competition worldwide, especially in China, he said.

“We are aware that some companies are looking into this space but none of them have either generated clinical data in a broad enough manner to gain regulatory approval in major jurisdictions,” said Taapken. “In China, there are no companies that have even started to do the clinical trials necessary for receiving CFDA approval.”

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STILL EARLY DAYS FOR LIQUID BIOPSY

MDDnowReutersSTILL EARLY DAYS FOR LIQUID BIOPSY

Multi-billion market opportunity draws variety of approaches from congested field of companies

http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=92613

By Amanda Pedersen

Tuesday, April 26, 2016

Analysts and market researchers often try to put a monetary value on an emerging sector but estimating the market potential of a new technology category is far from an exact science. The liquid biopsy market is a prime example of that challenge.

“There are a variety of numbers that have been thrown out by a variety of different sources and I think that’s really all to say it’s an embryonic area and people don’t really know where this is going to go,” Gene Walther, CEO of Vortex Biosciences Inc., told Medical Device Daily. “Some of the big firms, J.P. Morgan and Piper Jaffray have indicated that it’s a $22 billion to $32 billion market opportunity, but many of those are looking at the clinical applications and not really including or incorporating what the research potential is.”

Walther said the research applications in this space alone represents a market anywhere between $1 billion to $8 billion. Vortex, of Menlo Park, Calif., is among the many players that have seen the opportunity and potential of the fairly congested liquid biopsy field.

Suffice is to say the market for liquid-based cancer tests will eventually grow to become a multi-billion opportunity and there will be plenty of pie slices to go around. But what really makes this an interesting space is the variety of approaches liquid biopsy companies are taking with the technology and the array of purposes for which these various tests will be used.

This week, in a two-part series, Medical Device Daily is exploring both the potential clinical and business opportunities this young but fast-growing market has to offer.

Looking at the liquid biopsy space from the broadest viewpoint, it can be segregated by the type of liquid being collected: urine or blood. So far San Diego-based Trovagene Inc. appears to be the lone wolf in the urine-based liquid biopsy category while the majority of companies are duking it out for leadership on the blood-based side.

Zooming in on the blood-based sector, the market can be divided into at least four different categories based on the specific components of the blood the test is designed to capture — circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), nucleosomes and exosomal RNA — and some of those categories can be further split into subcategories, such as whether or not the test is used for clinical or research purposes and, if it is used in the clinic, is it being used to find cancer (detection) or to follow it (monitoring).

“A lot that work still needs to be done. I think the biology of cancer and really how we can maximize the use of liquid biopsies, whether it be the application of circulating tumor cells or circulating tumor DNA and how they can work and compliment each other still needs to be proven,” Walther said.

Finding the needle in a haystack

Vortex is trying to differentiate itself by not using any kind of labels such as magnetic beads or stains, but rather isolating intact CTCs to allow the end user to perform a variety of different types of analysis, such as next generation sequencing, growing the cells to be able to study them further or looking at the proteomics and the way the gene expressions are happening within the isolated tumor cells.

“By having these intact CTCs you’re able to do much more of a thorough and broad analysis on those cells,” Walther said. “Within that space what we think differentiates our technology and our approach is a higher purity.”

Vortex has developed a fully automated benchtop system called the Vtx-1 for collecting intact CTCs using microfluidic technology. Inside the Vtx-1 chip, unlabeled CTCs in whole blood are trapped in microsale vortices while smaller red and white blood cells pass through. After selectively trapping into the microfluidic chamber, CTCs can be flushed and collected into a variety of containers for downstream analysis.

This technique is easier said than done though. Walther explained that each blood sample contains billions of very small red cells and millions of slightly larger white cells and a much smaller number, roughly one to 500, of CTCs. It’s a lot like looking for a needle in a haystack, he said, and being able to isolate the CTCs from those red and white blood cells is a tremendous challenge. In the end, the Vtx-1 is expected to capture the CTCs in a sample of blood and only a minimal amount of white blood cells.

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He said the technology is able to clear the red blood cells fairly well but there are some residual white cells that will be left in with the CTCs. “When you compare it to other technologies, at least based on published reports, we believe that the purity of our technology is actually a high differentiation from the other technologies that are available,” he said. “The market is going to want to see some direct comparisons in the not-too-distant future to be able to actually differentiate the technologies.”

Walther said the company has generated a fair amount of interest from research labs and clinical labs but Vortex also has received notable attention from pharmaceutical companies because the ability to isolate CTCs and grow them presents an opportunity to test the effectiveness of various compounds they may have in development. That’s a distinct advantage over tests that use ctDNA, he said, because ctDNA shows fragments of DNA from cells that have been killed, in theory, by the treatments the patients are on.

“What it doesn’t capture is the residual cancer that may have become resistant to that drug or that may not respond to that drug,” Walther said. “It may be more effective in being able to determine cocktails of drugs. If you think about the approach that the pharma industry has taken fighting Aids, it’s a cocktail approach, it’s not a single drug.”

The company recently did a soft launch of the system to introduce it to researchers and plans to do a formal product launch early next year.

nucleosomes are the haystack

Volitionrx Limited, of Namur, Belgium, is trying to set itself apart in this crowded market by focusing on a cost-effective platform designed to work in multiple cancers and by looking at nucleosomes in circulation. The company received CE mark approval in April for two blood-based assays for the detection of colorectal cancer. The biomarker assays, Nuqv001 and Nuqt003 are designed to analyze fragments of nucleosomes circulating within the blood for the presence of cancer signatures. Volitionrx plans to launch a panel test for the detection of colorectal cancer for clinical use in Europe toward the end of the year.

“We’re not looking for the needle. The nucleosomes are the haystack,” CEO Cameron Reynolds told Medical Device Daily at J.P. Morgan’s health care conference in January.

Reynolds said his company’s test is so low cost that Volitionrx only spent about $18 million over five years to develop the assay because it is using a “very old platform” that is easy to roll out worldwide. He said if the company delivers what it intends to, which is a low-cost, accurate diagnostic screening blood test, it will “change everything.”

“People say blood tests are the answer and they really are,” Reynolds said. “But I think anyone in our business has to accept nothing has worked. Everyone’s very skeptical because the last big break through was 35 years ago with PSA for prostate cancer.”

For example, Reynolds said, thousands of papers have been published but not one has been launched and widely adopted as a screening test. Other companies are also looking at nucleosomes, he said, but he said those competitors are actually looking at the DNA wrapped around the nucleosomes.

Don’t dismiss RNA

Exosome Diagnostics Inc. is taking a very different approach in the liquid biopsy field with its test designed to isolate and analyze exosomal RNA from a blood sample. The plasma-based diagnostic is intended to enable real-time detection of EML4-ALK mutations in patients with non-small cell lung cancer (NSCLC). The company said its platform provides a more direct and sensitive method of detecting fusions such as EML4-ALK, compared to cell free DNA alone. EML4-ALK is a gene fusion found in a subset of patients with NSCLC and predicts response to ALK inhibitor therapies.

John Boyce, CEO of the Cambridge, Mass.-based company, told Medical Device Daily in February that DNA alone is not enough to solve the puzzle. Just like there will never be one drug that can cure cancer by itself, oncology doctors need more than one liquid biopsy tool to treat and monitor their patients, Boyce said. If they only measure the cell-free DNA to see if a particular drug is working, all they know is what is dying in the blood.

“And that’s good, you can see what’s dying, you can see that you’re killing off the [tumor cells] but you’re not able to see what’s on the rise,” Boyce said. “So it’s natural selection. As soon as you kill one of them off there’s a new bully on the block in the tumor.”

That’s something that can’t be identified with cell-free DNA, he said. “The only way you can do that is looking at the RNA and the only way that you can get the RNA from the blood is from exosomes because RNA doesn’t float around in the blood freely.”

In the end, Boyce said, oncologists need to see both what is dying and what is living in the blood.

Published  April 26, 2016

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Growing evidence supports clinical potential of new cancer tests

MedicalDeviceDailyGrowing evidence supports clinical potential of new cancer tests

By Amanda Pedersen, Senior Staff Writer

With a market opportunity in the billions (as much as $20 billion by some estimates), diagnostic companies are rushing the liquid biopsy floodgates with new tests designed to make finding and monitoring cancer as easy as a blood draw or urine sample. This week, in a two-part series, Medical Device Daily will explore both the business opportunities and the clinical potential of this growing market. The true clinical impact of this technology remains to be seen and there are some early limitations of these tests that will need to be addressed, but some doctors say liquid biopsies could really transform cancer treatment. To validate the power of
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FDA approves Epigenomics’ Epi proColon test

BioCenturyFDA approves Epigenomics’ Epi proColon test

http://www.biocentury.com/dailynews/company/2016-04-13/fda-approves-epigenomics-epi-procolon-test

Published on Wednesday, April 13, 2016

Epigenomics AG (Xetra:ECX) said FDA approved a PMA for its Epi proColon blood-based colorectal cancer (CRC) screening test. Epigenomics and Polymedco Inc. (Cortlandt Manor, N.Y.) will jointly market Epi proColon in the U.S.

Epigenomics spokesperson Peter Vogt said the partners expect to launch the test in the next few weeks, but did not disclose the list price.

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In November, Epigenomics appealed FDA’s request for additional data demonstrating that Epi proColon would increase compliance in patients with a history of non-compliance to recommended CRC screening programs. The request came in a response letter for Epigenomics’ PMA, the second it had received for Epi proColon.

Epi proColon detects methylated DNA of the septin 9 (SEPT9) gene in blood plasma by real-time PCR.

Epigenomics gained EUR 1.31 (25%) to EUR 6.58 on Wednesday.

Exact Sciences Corp. (NASDAQ:EXAS), which markets CRC screening test Cologuard, rose $0.34 to $7.46 on Wednesday. Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene.

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Epigenomics scores FDA approval for colorectal cancer screening test

FierceMedicalDeviceshttp://www.fiercemedicaldevices.com/story/dx-digest-epigenomics-wins-fda-approval-colorectal-cancer-test-nanostring-a/2016-04-13

Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Epigenomics won FDA approval for its colorectal cancer screening tool. Testing heavyweight Siemens also got a regulatory nod for its Graves’ disease (GD) test. Last but certainly not least, NanoString Technologies and HalioDx teamed up to develop immuno-oncology gene expression tests. Read on for the details. And as always, feel free to contact us with any comments or questions. — Emily Wasserman (email | Twitter)

Epigenomics scores FDA approval for colorectal cancer screening test

German and U.S.-based molecular diagnostics firm Epigenomics got FDA approval for its blood-based colorectal cancer screening test.
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Epigenomics’ Epi proColon uses a blood sample to see whether or not patients are at risk for developing the disease. The test provides an alternative to other colorectal cancer screening methods including colonoscopy and stool-based fecal immunochemical tests.

The FDA based its approval on three major clinical studies, which showed that Epigenomics’ test was safe and effective in screening for colorectal cancer. But regulators are also asking the company to run a post-approval study to show Epi proColon’s long-term benefit.

The Berlin and Germantown, MD-based firm will market Epi proColon in the U.S. under a joint agreement with its partner Polymedco, who specializes in noninvasive colorectal screening technology.

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FDA Approves Epigenomics’ Blood-Based Colorectal Cancer Screening Test

genomewebFDA Approves Epigenomics’ Blood-Based Colorectal Cancer Screening Test

https://www.genomeweb.com/molecular-diagnostics/fda-approves-epigenomics-blood-based-colorectal-cancer-screening-test

Apr 13, 2016

a GenomeWeb staff reporter

NEW YORK (GenomeWeb) – Epigenomics announced today that the US Food and Drug Administration has approved the company’s blood-based colorectal cancer screening test Epi proColon.

Epi proColon is a PCR-based test that detects methylated Septin9, a biomarker already incorporated into laboratory-based tests currently available in the US. It is now approved for use in average-risk patients who choose not to undergo screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests, and will be co-marketed by Epigenomics and strategic partner Polymedco.

The FDA approval comes after a series of setbacks for Epigenomics. Although Epi proColon received a positive recommendation from an FDA advisory panel in early 2014, the agency issued Epigenomics a “not approval letter” for the test a few months later.
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In its letter to Epigenomics, the FDA noted that the firm’s clinical studies of the Epi proColon were conducted in patients who had agreed to a routine screening colonoscopy, and asked for data demonstrating that the test would boost compliance to colorectal cancer screening in its intended population of patients who currently don’t undergo such screening.

Meanwhile, Exact Sciences’ stool-based colorectal screening test Cologuard got a nod from the advisory panel in 2014 and was approved by the FDA that August. The Centers for Medicare and Medicaid Services also issued a proposed national coverage determination for the test.

In July 2015, Epigenomics received some good news when China included the Epi proColon in its screening guidelines for colorectal cancer. However in late 2015, the FDA said it would require yet more data before making its own decision on the test. It was not until this January that the FDA told the company the additional information it had submitted was sufficient.

“We are excited by the FDA’s decision to approve Epi proColon as the first and only blood-based colorectal cancer screening test,” Epigenomics CEO and CFO Thomas Taapken said in a statement. “Given the significant benefits for patients, healthcare professionals, and payors, Epi proColon could help to meet the objective of 80 percent screening compliance of the eligible US population as pursued by US guideline bodies such as the American Cancer Society.”

Epigenomics said that it intends to conduct a post-approval study to demonstrate the long-term benefit of the test.