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.

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.”

Duchenne candidate Raxone (idebenone)

fiercebiotech

 

 
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May 4, 2016

Santhera Pharmaceuticals has announced a slew of updates in regards to regulatory filings for its Duchenne candidate Raxone (idebenone). The Swiss biotech said it plans to submit “comprehensive briefing material” and a meeting request to the FDA to discuss filing an NDA for DMD patients who are not taking concomitant glucocorticoids. Santhera said it will also submit a new marketing application for Raxone in Duchenne to the EMA. In addition, it’s reporting the launch of a new Phase III (SIDEROS) clinical trial in DMD using glucocorticoids. Patient enrollment will start in coming weeks