Anyone who has experienced or witnessed chemotherapy treatment knows that it's a physical trial of the first degree. You're poisoning the body in order to cure it.
 
The problem is that while chemotherapy causes side effects in all patients, it cures the cancer of only some. Until now, it has been impossible to know whether chemotherapy is working until the treatment is complete. This means a large number of cancer patients suffer for naught.
 
Rna Diagnostics, a Toronto-based molecular diagnostics company, is trying to change this by removing the guesswork. It has developed a tool called the Rna Disruption Assay (RDA), a test administered in the first cycle of chemotherapy that determines how a patient is responding. A patient that is not responding can move on to other treatments without the agony of chemo. Starting with a focus on breast cancer, Rna Diagnostics is betting that its approach will not only reduce the suffering of a wide array of cancer patients, but will also save the healthcare system money.
 
The RDA is the outcome of a clinical trial lead by Dr. Amadeo Parissenti, director of research at the regional cancer program at Laurentian University in Sudbury. Dismayed by the statistics—that only between 10 and 20 per cent of chemotherapy patients live longer as a result of the treatment—Parissenti decided to try something unusual. He'd study the tumour itself over the course of treatment.
 
Standard protocol is to remove the tumour before chemotherapy. Leaving the tumour in place was generally only done in cases where the tumour was so big that it needed to be shrunken down before it could be removed.
 
"At the time, we were one of two groups in the country that were doing it," Parissenti says. Taking a sample from a tumour was perceived to be unnecessarily risky. There was the risk of dislodging cells, which could precipitate metastasis, and the risk of infection.
 
Despite these risks, which turned out to very minimal, Parissenti and his team got permission and funding to run a trial with breast cancer patients at the Sudbury Regional Hospital.
 
Breast cancer patients were the obvious choice of test group for three reasons. Breast cancer is the second most common form of cancer worldwide, after lung cancer, and the most common form of cancer among women. Second, the tumour is relatively accessible and therefore can be sampled with minimal invasion. And third, compared to lung cancer, it's a slow growing cancer, so there's often time to try many treatment options.
 
Researchers first isolated RNA from a sample of tumour cells to do a full genomic analysis on them.
 
"It was an expensive procedure and we wanted to make the most of the test by making sure the RNA samples were good quality and not degraded," says Parissenti. But the samples they were getting were highly variable, some were good quality and others were degraded and "unreadable." The team assumed their extraction technique was flawed until they realized that all of the samples taken from the pre-treatment tumours were good quality. This suggested that chemotherapy was playing a role in the degradation process.
 
"At the very highest doses of the chemotherapy drugs, there was complete destruction of the RNA and then we thought: Okay, this is not an accident," says Parissenti.
 
The team realized that the quality of RNA after one cycle of chemotherapy is a very good indication of whether the therapy is likely to destroy the cancer altogether. Having that knowledge could help doctors determine much better treatment plans for their patients.
 
Parissenti and his team wrote a paper on the findings and filed a provisional patent. It was a year later, when it was time to file a Patent Cooperation Treaty (PCT), a more expensive process, that Parissenti thought about finding someone to bankroll the project, and take control of the commercialization process.
 
Gisele Roberts at the intellectual property management office at Laurentian told Parissenti about the BioDiscovery program at the MaRS Innovation Centre, whose mission is to connect medical discoveries with business investors. Parissenti applied and was granted one of the coveted slots to present his idea to a room full of angel investors and venture capitalists.
 
After his presentation he was approached by John Connolly of York Medtech Partners Inc., a Toronto-based company that invests in groundbreaking medical technologies. Connolly asked him if he would repeat his presentation the next day to the York Medtech staff, including Dr. Ken Pritzker, former chief of pathology at Mount Sinai Hospital, and an expert on cancer-related diagnostic tests.
 
Though Pritzker and York Medtech were interested, they didn't commit right away. It was only weeks later, when Parissenti presented his idea to Marc Castel, director of commercialization at Ontario Centre of Research, who happened to be in Sudbury, that things moved ahead. Castel was familiar with York Medtech Inc. and thought the RDA was the right fit for them. He helped broker a formal arrangement.
 
"It was around 12 or one in the morning. It was the way you'd imagine business would be done but often isn't," Parissenti says. "Mark is quite an impressive guy."
 
Together the staff of York Medtech and Parissenti, as chief scientific officer, formed Rna Diagnostics Inc.
 
While Parissenti is busy in his lab in Sudbury, the Toronto-based team has been raising money and establishing RDA's credibility. They have been remarkably successful at both these things.
 
Incorporated in March 2010, the company has raised more than $1 million in seed money from agencies across the province including the Ontario Centre for Excellence's Centre for Commercialization of Research, the Health Technology Exchange and most recently, the Ontario Genomics Institute.
 
They have also put together a board of directors with the top breast cancer researchers in the world.
 
The RDA won a slew of awards at the 2011 TiEQuest Awards in Toronto, an annual business venture competition, including best new business venture, best venture in the health-care field, and tied for best intellectual property award. It also won the top prize at the 2010 Sanofi Pasteur Healthcare and Biotechnology Venture Challenge co-hosted by the Schulich School of Business at York University and York Region-based VentureLAB.
 
Part of the appeal of Rna Diagnostics efforts is that patients would not be only beneficiaries.
 
"You don't have to calculate very hard to see the potential savings," says Pritzker, who became the company's CEO. "This is one of the reasons we've received so much support from government agencies."
 
The RDA reflects the goals of a new personalized approach to medicine, which is to offer the right treatment to the right patient at the right time. In January 2012, the federal government announced a $67.5 million investment in projects that would help promote a new precision-oriented healthcare system.
 
"These things take a lot of time," says Pritzker. "You have to get a lot of data and you have to convince people that the data is right."
 
A group of mathematicians is currently working to perfect the algorithms associated with the scores given to the RNA samples. The degradation process is more of a pattern than a single instance. These algorithms allow the oncologist to interpret the pattern in terms of whether or not treatment should be continued.
 
The RDA is about a year and a half away from being commercially available. Currently the team has data from two studies, which is enough to convince doctors to use it in their research, but not quite enough to convince them to use it in their practices, Parissenti says. At the moment there are studies underway in Canada, Germany and Italy.
 
If the conclusions from these studies match the preliminary conclusions, uptake for the RDA will be fast. It's expected to enter a $500-million market.
 
Down the road it is very likely that the team will adapt the RDA procedure for other forms of cancer and for other treatment drugs.
 
"This idea, the RDA and its technology, is very repeatable but it really wasn't understood until we got into it. It's opened up a whole world of science and a whole world of business," says Pritzker. "As you can see, we're a startup. We have to focus on one area, we can't do the whole world at once."
 
Mary Albino is an economics reporter and writer based in Toronto.