By Tony Fong
NEW YORK (GenomeWeb News) – Following the results of a study suggesting that its genomic test may have use in predicting chemotherapy response in patients with breast cancer, Nuvera Biosciences said that a launch of the test, as well as another for predicting endocrine therapy response, is in the works.
Earlier this month, the company and its collaborators on a gene-based companion diagnostic test for breast cancer reported promising results for the test, which combines estrogen receptor status, predicted chemoresistance, predicted chemosensitivity, and predicted endocrine sensitivity.
In the study, published in the May 11 issue of the Journal of the American Medical Association, the authors said that patients who were predicted to be sensitive to taxane-anthracycline chemotherapy had a 56 percent probability of "excellent pathologic response" and distant relapse-free survival of 92 percent, as well as an absolute risk reduction of 18 percent.
The test, they added, was able to identify patients with high probability of survival following taxane-anthracycline chemotherapy.
Based on those results, Nuvera is in the process of validating the test for launch in a CLIA format and is now seeking a commercialization partner. And during the second half of this year, the company anticipates it will embark on a strategy to receive clearance from the US Food and Drug Administration for the test, Nandan Padukone, CEO of Nuvera, told GenomeWeb Daily News.
Additionally, the Woburn, Mass.-based firm plans to launch another test for predicting breast cancer patient response to endocrine therapy. In a study published last summer in the Journal of Clinical Oncology, Nuvera and its collaborators said that the test, consisting of 165 genes, "predicted survival benefit from adjuvant endocrine therapy, not inherent prognosis."
Both tests were co-developed with the University of Texas MD Anderson Cancer Center.
Mapping a Market Strategy
Two years ago, Nuvera and Veridex, a Johnson & Johnson company, signed a commercialization deal covering the two assays, and Veridex continues to help Nuvera map out a commercialization strategy.
"We will continue our work with them as they create their own areas of emphasis within personalized medicine," Padukone said. "But we will also seek other commercial partners since there would be elements of creating new geographic markets and exploring extensions into cancer indications with the tests."
Nuvera, Padukone said, is currently speaking with large diagnostics firms and pathology companies about potentially teaming up. With its endocrine therapy and chemotherapy tests for breast cancer progressing toward commercialization, the company also plans to develop other tests to expand its portfolio, with attention being directed at companion diagnostic assays for breast cancer, with a focus on newer therapies.
Nuvera also may explore the development of tests for predicting response to other cancers. The tests would be targeted at therapies that have been used primarily for breast cancer, but which have shown efficacy for other indications, Padukone said.
Nuvera was founded in 2005 with technology from MD Anderson, which is a stakeholder in the company. In addition to developing companion diagnostics, it offers research services. The company is also "well funded" with grants from the National Institutes of Health and the Department of Defense and currently operates at break-even, Padukone said.
Nuvera has spent the past four years developing its endocrine therapy and chemotherapy tests for breast cancer. Its approach has been to take therapies that are known to have efficacy, such as taxane and tamoxifen, but rather than start new trials, Nuvera revisits old ones, takes the tissue samples, and then profiles them.
The advantage of this approach, Padukone said, is that unlike with the newest therapies, such as PARP inhibitors, the therapies Nuvera is interested in are already on the market, so once Nuvera's tests are clinically validated, they have immediate use.
Nuvera's two tests together currently consists of about 250 genes, which Padukone said will most likely be unchanged when they go to market. "We are no longer in the phase where we are still selecting genes," Padukone said.
In addition to the US, the company is eyeing Europe and is in discussions with potential partners for commercialization of its tests there, though Pandukone said that because of the fragmented nature of the European market, it may take longer to enter that space and gain a foothold.
The goal for now is to prepare its tests for a CLIA launch in the US by the end of the summer. During the second half of the year, Nuvera anticipates launching a regulatory strategy for approval by the FDA, and in 2012 submitting an application to the agency, Padukone said.
If Nuvera is successful in commercializing its tests, they would compete with other tests already on the market, such as Agendia's MammaPrint assay, which received approval from the US Food and Drug Administration as an in vitro diagnostic multivariate index assay in 2007, as well as Genomic Health's Oncotype Dx Breast Cancer assay.
According to Padukone, Nuvera's tests would be complementary to those companies' products because they mainly provide information about whether a patient has a high or low risk of recurrence.
"But those tests, unfortunately, don't answer … if you do need therapy, what kind of therapy should you be put on," he said. "And that's where our tests tend to define that better."
Nuvera's tests also would not compete with tests being developed to predict patient response to PARP inhibitors and other new therapies, he added. Its tests for chemotherapy and endocrine therapy is for stages 1 through 3 breast cancer, but not for stage 4 disease when the cancer has metastasized.
Though the two tests are separate from each other and were developed independently, the idea is that a patient who has been diagnosed with breast cancer would receive both tests as a way of determining which treatment would be best for a specific patient.
In the US, 207,090 women and 1,970 men were newly diagnosed with the disease in 2010, according to the National Cancer Institute.
Nuvera's tests run on Affymetrix microarray technology, and Nuvera anticipates retaining that technology because in the US, it is "perhaps more readily adoptable" than a purely reference lab format, Padukone said. "We'll probably stay with the [microarray] format because it has helped us not just in the design and validation phases, but to get it into the hands of some early adopters, I think that [the technology] should help us a lot."
However, the company is exploring the possibility of migrating its tests to other technologies, such as PCR, as well as other sample types such as paraffin-embedded tissue in order to extend their use in markets where microarray technology is not accessible, Padukone said.
"When we look at growth markets … then we can look at the question of how extensive microarray [use is] in certain markets," he said. "Hopefully, we'll have enough development done in the next year or two that, if needed, we can transition into other formats," he said.