Roswell Park Cancer Institute is about to find out if its big bet on personalized medicine will pay off.
If it does, it could speed up a reinvention of cancer care – and put the Buffalo cancer center in the forefront of the new world of personalized medicine.
Roswell Park’s new test for lung cancer is at the center of the scientific and business enterprise.
The institute has spun off a company, OmniSeq LLC, to market the test to cancer specialists and hospitals in the United States.
It’s the largest commercial venture ever for Roswell Park. The institute has invested more than $25 million to develop the test tailored to the unique genetic characteristics of patients.
The new test lets doctors customize treatment to a patient’s tumor and the underlying molecular changes causing the cancer. For each patient, the test identifies the genetic mutations that are driving the lung cancer and doctors can prescribe a drug aimed at the mutation, not the tumor in the lung.
The institute sees it as a potential financial success, and researchers are working to extend it to other cancers.
“The launch of OmniSeq is going to make a significant difference to patients,” said Candace Johnson, chief executive officer of Roswell Park. “It’s significant for Roswell Park, too. It gets our name out there. It establishes us in the genomic space, and that is the future.”
OmniSeq, also the name of the new test, represents Roswell Park’s push to compete nationally in a hugely hyped field of medicine that advocates call a potential revolution in cancer care. If OmniSeq gains acceptance among doctors, it offers Roswell Park an even larger opportunity – using the test to develop better drugs that target patients’ gene mutations.
The Western New York Regional Economic Development Council, one of 10 regional councils Gov. Andrew M. Cuomo appointed to spur economic development, awarded $5.1 million for the Center for Personalized Medicine at Roswell Park. The cancer center invested $20 million of its own to hire staff, install a supercomputer and buy devices called sequencers to analyze genes.
Roswell Park isn’t alone. A handful of health centers, universities and big companies are chasing the same goal – including Stanford and Harvard universities – and bringing even more money and staff to their efforts.
“Some of the leading institutions in the country see the opportunity in personalized medicine. Now, we’re entering that scene and are among them,” said Dr. Carl Morrison, executive director of the Center for Personalized Medicine.
Targeted genetic therapy remains a work in progress. No one knows yet if personalized medicine will fulfill its promise or how much it will cost. So far, insurers have treated tests like the one developed by Roswell Park warily because their results can steer patients toward costly experimental therapies that do not yet have proven results.
Roswell Park has spent months negotiating with insurers for coverage for the test but declined to provide details.
For decades, cancer treatment has centered on the organ where a tumor is found in the body. The concept of personalized medicine centers around how, genetically, each person’s cancer looks as unique as a fingerprint and should be treated as such.
Finding genetic defects to diagnose and then treating cancers and other diseases is no longer science fiction.
Today, it is possible to sequence a person’s genes in a few days for a few thousand dollars, and the cost and time continue to drop.
Challenges remain, but the technology for accurate, high-speed genetic sequencing – combined with the computing capability to make sense of the genetic complexities and incorporate it smoothly into a doctor’s medical practice – appears ready.
President Obama in his State of the Union speech earlier this year called for a $215 million federal investment in personalized medicine. Experts put the potential value of the market in the billions of dollars.
Tests like OmniSeq are considered game-changers because they can quickly search for multiple alterations.
Foundation Medicine in Cambridge, Mass., for instance, markets a $5,800 test that searches for 315 cancer-related genes. Other groups also see an advantage in simultaneously examining hundreds of genetic alterations, despite many currently lacking a treatment.
Roswell Park took a different approach. OmniSeq looks only at the known mutations related to non-small cell lung cancer for which there is an approved drug, an experimental drug or a drug for another cancer that can be used off-label.
The institute is preparing similar tests for other cancers, including colorectal and melanoma.
Roswell Park is betting that doctors will favor a narrowly focused test that targets mutations for which there is a therapy and that can be ordered through their offices.
“Personalized medicine has been a rich man’s game so far. You can only get it at the largest institutions,” Morrison said. “We’re trying to bring it to the community oncologist.”
The new company employs 30 people and will be located in the Hauptman-Woodward Medical Research Institute adjacent to the cancer center. Officials said Hauptman-Woodward wanted a tenant, offers a convenient location and, with its noted architectural design, creates a “wow factor” for potential clients.
In addition to the test, OmniSeq will market a Web-based patient information system that physicians and hospitals can incorporate into their electronic medical records. The company also will maintain a genomic network, creating a giant database that doctors can access to track how others elsewhere on a case-by-case basis tackled particular cancers, many of which will be rare.
“You have to bring the access to the technology down to the patient,” said Mark Aguillard, OmniSeq’s vice president of marketing and managed care.
Roswell Park also sees an opportunity in serving as the behind-the-scenes “engine” that supports personalized medicine centers at other institutions. That’s because the test and technology that surrounds it are difficult and expensive to replicate.
The institute cleared a major hurdle last year when the New York State Health Department approved OmniSeq, allowing doctors to use it. With a lack of federal test standards so far, New York’s decision is viewed as an unofficial national seal of approval concerning the reliability of the test results.
Officials said they anticipate announcing their first customers soon.