As founder and CEO of BioArray Therapeutics Inc., a Connecticut-based cancer diagnostics startup, Marcia Fournier has heard from hundreds of breast cancer patients and their families about the physical, emotional and financial toll that chemotherapy treatments have taken on them.
"After the initial diagnosis, about 75 percent of early-stage breast cancer patients undergo chemotherapy," she said. "There's a lot of pain and suffering." Of that 75 percent, Fournier said, only 25 percent will completely respond to the chemo treatment.
That prompted Fournier to ask a fundamental question: What if a patient's response to a particular cancer treatment could be predicted? It's a question Fournier — and the company she founded in 2009 — have been trying to answer. And the diagnostics testing product BioArray has developed — expected to hit the market in 2016 — has not only produced strong preliminary results in clinical trials but has attracted capital investment from a number of Massachusetts and Connecticut investors, including Connecticut Innovations, the state's quasi-venture capital arm.
"BioArray is taking a unique approach to developing a diagnostic test that could remove the guesswork from breast cancer treatment options and identify the treatment plan that will deliver the best outcome for the patient," said Patrick O'Neill, director of investments for Connecticut Innovations, which has invested $700,000 in BioArray since 2013. "The result of our continued investment in the company could improve the chances of disease-free survival for many patients."
The state's recent bioscience infrastructure investment was a main reason, Fournier said, she moved her company from Boston to Connecticut. The Nutmeg State — through UConn's incubator program — also helped BioArray establish its footing. The company originally had lab space in Farmington before recently moving to New Haven.
"The incubator program provided us with the physical laboratory space, a strong academic surrounding, and the exchange of knowledge," Fournier said. It also helped with the most urgent resource for any startup: capital. "The program helped connect us with a network of investors who, in turn, helped us hire a staff of four highly trained personnel and helped us develop our product."
BioArray's product helps analyze and decode genes and molecules of a cancerous tumor, which, when run through a supercomputer, has shown in a proof-of-concept clinical trial of 147 patients to predict the effectiveness of treatment with high accuracy and low false negative rates. The clinical trial was sponsored by the National Cancer Institute.
"We were able to model and validate our diagnostics," she said. "We wouldn't be where we are without that collaboration."
Fournier hopes that her company's product will revolutionize cancer treatments. "Most predictive testing today is based on telling a person whether they will likely get cancer," she said. "We're unique in that our product predicts the effectiveness of cancer treatments."
It's part of an evolution in the medical industry — known as precision medicine — that is both growing and attracting federal dollars. In fact, President Obama's fiscal year 2016 proposed budget included $200 million to the National Institutes of Health (NIH) earmarked for precision medicine, including $70 million specifically for cancer genomics research.
Fournier said reducing or eliminating ineffective treatments will not only provide a better patient experience but will save the healthcare system significantly.
"The first line of chemotherapy alone can cost $20,000 per patient," she said. "By using predictive diagnostics-based treatments, we could achieve over $1 billion in annual savings in cancer treatment alone."
If the potential cost savings are big, so is the market opportunity in the breast cancer industry. In fact, Fournier said breast cancer diagnostics is a $1.5 billion a year industry. While there are a number of companies in the diagnostics space, Fournier sees one main competitor for her company: the trial and error method.
That's something she hopes to change. "If you treat the patient right the first time [using predictive medicine] he or she is less likely to relapse."
From her office at Yale University's Science Park in New Haven, Fournier anticipates BioArray will launch its first product within the next 12 months. She said the company has a long-term plan — over the next five years — to expand its diagnostics testing to address other types of cancer treatments as well, but she knows that will take continued investment from outside funders.
But capital is only one challenge. "Moving forward, we need to remain flexible to address regulatory changes and be able to adapt as we need too."
She hopes cancer treatments continue to adapt as well. In fact, she predicts it.