VOLUME 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.”