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Clinica's MedTech Ventures: Origin Sciences

This article was originally published in Clinica

Executive Summary

Clinica’s Medtech Ventures: Origin Sciences
Specialty area(s): Gastrointestinal disease detection and monitoring
Based in: Cambridge, UK
Founded in: 2004
No. of employees: 7
Total investment received to date:  £7.5m ($12.0m)
Investors:  Animatrix Capital, LLP and 31 other UK and European investors

Detecting colorectal cancer earlier improves survival, and several companies are currently developing better diagnostics. This includes Exact Sciences, whose stool-based DNA test Cologuard recently got a reimbursement code in the US.

But not all people comply with stool-based testing, which involves them taking their own sample at home and sending it off for analysis. This is because of the taboo over handling stools, as well as hygiene worries, and a general preference that doctors should carry out these kinds of examinations, according to an article published in the British Journal of Cancer in April 2014.

UK diagnostics company Origin Sciences has worked with doctors to develop a device that could help address these issues, called OriCol, which is used in the doctor’s surgery. The device is inserted into the rectum through a proctoscope and a balloon-like membrane is inflated with air using a syringe. The membrane collects material from the mucocellular layer of the rectum, the membrane is deflated and the device is removed.

The mucosal material is then analyzed for biomarkers that are involved in a particular disease. OriCol is currently CE marked for sale in Europe as a collection device, but it is not yet approved for any specific indications.

Origin is initially targeting a test for colorectal cancer, commercial director Graham Griffiths told Clinica, but OriCol could also be used in the diagnosis of other gastrointestinal diseases including inflammatory bowel disease (IBD, which includes Crohn’s disease and ulcerative colitis) and irritable bowel syndrome (IBS). The firm is also studying its use in monitoring the human gut microbiome, which has been implicated in various areas including food allergies and response to chemotherapy.

The company is currently working with several partners, including Oxford University, to investigate OriCol’s use with different biomarkers. One marker it is studying is calprotectin, which indicates inflammation and increased levels of this marker have been associated with various conditions including colorectal cancer and IBD. The marker could also be used to monitor fluctuations in IBD and perhaps tailor treatment plans.

But it is the collection method, rather than the markers involved, that makes OriCol novel, Mr Griffiths stressed. Some of the markers the company is looking at are also involved in stool-based testing, such as hemoglobin, he added.

Origin is currently building its distribution network in Europe, and is initially targeting Germany, Austria, France, Turkey and the UK. It already has one distributor secured and another two to three lined up, according to Mr Griffiths.

As for the US, the company is “exploring” possibilities at the moment, he said, adding that Origin is expecting to get investigational device exemption (IDE) approval to start a study in the country in the next few months. He hopes OriCol will be regulated under the FDA’s less stringent 510(k) pathway.

So could OriCol actually be preferable to stool-based testing from a patient perspective? When asked if patients found the device painful, Mr Griffiths replied that in a study carried out by Origin, around 85% of patients said they had experienced “no discomfort.”

And it is infinitely preferable to colonoscopy, which is more invasive and also involves extensive bowel preparation (usually laxatives) and sometimes sedation, meaning people often have to take several days off work. Origin is keen to point out that OriCol requires no bowel preparation and can be carried out in five minutes.

Once the sample collection has been carried out, OriCol also has advantages. Compared with stool-based tests, sample preparation for lab testing of material obtained with OriCol is much easier and cleaner than stool testing. “It’s more convenient for everyone,” concluded Mr Griffiths.

As well as looking at molecular markers, Origin is also developing OriCol to analyze protein markers, which could make it cheaper than Cologuard, which looks at DNA. But Mr Griffiths was reluctant to pit the two tests against each other. “We see Cologuard as an overall positive for the colorectal cancer screening market,” he said. “But the problem with stool testing is low compliance.” If Origin can deliver a test with similar accuracy, it may have the edge because its device is “more acceptable to patients.”

Another much-publicized method of detecting colorectal cancer could be blood testing, which could be even more acceptable to patients. But Mr Griffiths noted data suggesting that CRC markers are not reliably evident in the blood. The forerunner in this area is Epigenomics, which hit a hurdle when it got a “not approvable” letter from the FDA for its Epi proColon blood test in June. The test could eventually find a niche in people who do not attend colonoscopy and refuse to do stool-based testing, but its eventual approval is far from assured.

Going back to Origin, for now it is focused on several short-term goals: increasing the uptake of OriCol; adding IBD and gut microbiome to the testing portfolio; and growing the business. And it has enough cash to fund these activities, although Mr Griffiths isn’t ruling out future fundraising during the next 12 months.

Graham Griffiths, commercial director. graham.griffiths@originsciences.com

Origin Sciences Limited, 1 Riverside, Granta Park, Great Abington, Cambridge, CB21 6AD, UK.

http://www.originsciences.com/

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