Innovations: Agendia uses genomics to pair patients with best breast cancer treatments

Breast cancer is one of the most prevalent cancers in the U.S., and it's also one of the most treatable. But those treatments often come with tough side effects.

Patients typically have chemotherapy, surgery, radiation or a mixture of those treatment options to eradicate or shrink the cancer.

Irvine, Calif.-based Agendia has developed a test the company says makes it easier for physicians to determine if chemotherapy is necessary, sparing many patients from the toxic effects of the drugs, which can include preventing young women from having children after treatment.

Agendia's MammaPrint uses a 70-gene assay to determine whether a woman has high- or low-risk breast cancer rather than using a standard clinical risk analysis that relies on tumor grade and other factors. If MammaPrint shows a patient has high-risk breast cancer, it's recommended they receive chemotherapy treatment. Low-risk patients can forgo chemotherapy and have a similar five-year survival rate, according to research.

Recent results from Agendia's 6,700-patient study called Mindact, published in August by the New England Journal of Medicine, found that 46% of patients considered to be at high risk of breast cancer recurrence based on clinical-pathological features can pass on chemotherapy and are actually low risk according to the test.

Agendia expects to receive more results from Mindact later this year, which could lead to more centers using the study and better reimbursement agreements with insurers. Early results from the study have corroborated that MammaPrint can identify which patients should or shouldn't receive chemotherapy treatment, and they will have similar five-year survival rates.

The studies have also shown MammaPrint detected some high-risk patients that should have received chemotherapy but didn't because of their cancer's clinical presentation.

Agendia was founded in 2003 as a spinoff from the Netherlands Cancer Institute, and it still has connections there. The company has two CMS-certified laboratories for analyzing breast cancer specimens—one in Amsterdam and one in Irvine, Calif.—and they receive samples from around the globe.

Analyzing patient specimens takes four days. The company confirms the tumor diagnosis before micro-dissecting the tumor sample and applying the genomic test. The results are then sent to physicians via the cloud, helping them make real-time decisions about a patient's therapy options.

While there are other genetic tests that calculate whether a patient's breast cancer is high-risk or low-risk, MammaPrint is the only one cleared by the U.S. Food and Drug Administration.

“We just think it's the right thing to do to make sure our package, our process, everything is up to snuff in terms of quality and compliance,” Agendia CEO Mark Straley said. “We believe it sets the new standard, the new bar by which any coverage decisions need to stack up.”

Dr. Peter Blumencranz, medical director of the Comprehensive Breast Program and Cancer Services at Morton Plant Mease Health Care in Clearwater, Fla., said he believed Agendia's science was better than its competitors at guiding clinicians to the best course of treatment for each patient. “That is the point—one size doesn't fit all,” Blumencranz said. “It's a matter of what surgery is appropriate, what medication is appropriate.”

Blumencranz's center treats approximately 500 breast cancer patients every year. While the center doesn't order MammaPrint for every patient, Blumencranz says that MammaPrint and another Agendia test—BluePrint—help physicians make personalized care decisions.

BluePrint is an 80-gene assay Agendia has developed to help guide hormonal therapy decisions before patients even get to chemotherapy treatments. According to Straley, if the right hormonal therapy is selected, it could eliminate the need for chemotherapy later on.

The company also is working with several pharmaceutical companies on clinical trials that pair MammaPrint as a companion diagnostic to breast cancer drugs. “It's a growing and burgeoning piece of our business as well and will allow us to expand broadly and deliver on the promise of really helping deliver on this personalized medicine one patient at a time,” Straley said.

Correction, Oct. 5, 2016: