Johnson & Johnson company Veridex will help array-based molecular diagnostics company Nuvera Biosciences market two cancer assays worldwide, Nuvera said last week.
Under the terms of the deal, Veridex will commercialize Nuvera's tests for predicting patient response to tamoxifen and taxane-containing chemotherapy in breast cancer.
The assays are currently still in development, and Nuvera is working to discover and validate signatures for the assay. The agreement with Veridex is also open to future tests in as-yet unknown indications.
The deal also calls for Nuvera to use its diagnostics and bioinformatics expertise to validate tests, and for Veridex to clinically study the assays and commercialize them through its sales and marketing operations.
Nuvera, based in Waltham, Mass., could receive an upfront payment and revenue-based milestone payments over the next several years from Veridex, the companies said. Nuvera could also receive royalty payments for product sales generated by Veridex worldwide.
Financial details were not disclosed.
Nuvera's debut assays are NuvoSelect eRx, which is designed to identify breast cancer patients likely to respond to endocrine therapy, and NuvoSelect cRx, which is designed to help predict how a patient with the disease will likely respond to taxane-based chemotherapy.
Both tests were developed on the Affymetrix GeneChip platform in collaboration with oncologists at MD Anderson Cancer Center in Houston, from where Nuvera spun out in 2005.
According to Nuvera CEO Nandan Padukone, these two assays are the first of what the company envisions will be a pipeline of array-based tests that it will develop and that Veridex will commercialize.
"The array format has worked well for us in developing these two assays, and we will continue to use the array platform, whether it is expression- or genotyping-based, to look at other therapies to build our pipeline," Padukone told BioArray News this week.
He did not elaborate, but said the company is currently looking into assays that could help predict patient response to common therapies for colon and ovarian cancers.
The new eRx and cRx assays were developed by Nuvera and its partners at MD Anderson to help clinicians better select breast cancer treatments.
Nuvera began investigating breast cancer because of the different treatment options available and the possibility to impact how those treatments are pursued, Padukone said.
Currently, approximately 183,000 women and men are diagnosed with breast cancer annually in the US, according to the National Cancer Institute. Most patients either receive endocrine therapy, led by tamoxifen-based regimens, or taxane-containing chemotherapies.
Only around 25 percent of women who receive chemotherapy or endocrine therapy derive any benefit from it, "but all of them get it because there is no other solution," Padukone said. "That's the challenge for the industry and for MD Anderson."
According to Padukone, Nuvera’s assays are designed to "identify patients before they are given [these drugs] … to see if they are a likely responder" to them.
Both assays rely on a signature of markers developed on Affymetrix expression arrays, though Padukone said that there is a possibility that they may become available on some other technology platform. Some companies with competing tests have chosen to move their assays to RT-PCR-based Taqman assays to lower costs for potential users, while others have stuck with arrays.
For example, Genomic Health’s OncotypeDx assay uses a 21-gene signature on an RT-PCR-based assay to gauge the likelihood of breast cancer recurrence in women previously treated for the disease.
Agendia’s MammaPrint assay, in contrast, uses a 70-gene signature to predict breast cancer recurrence on an array manufactured by Agilent Technologies. Both Genomic Health and Agendia claim their assays predict patient response to traditional chemotherapy, including tamoxifen and taxane-based drugs.
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Unlike RT-PCR or an Agilent-made array, Affy's platform is a closed system in which potential users might have to invest in Affymetrix instrumentation to run Nuvera’s diagnostics.
Padukone said he is aware of the issues associated with bringing an array-based test to market, but said that arrays offer the best vehicle for predicting patient response to cancer therapies.
"Therapy response is a complex phenomenon and a small set of genes is not enough," Padukone said. He said that Affy's arrays had given the firm an "advantage" in narrowing down its list of candidate genes. He did not commit to launching the assays on the Affy platform, but noted that Veridex is a Powered by Affymetrix molecular diagnostics partner, which gives it the right to develop and sell GeneChip-based tests.
"It hasn't been determined what the best format to launch these tests is, but for development it is shown that Affy is a good platform to do this," he said.
Padukone said Nuvera is working closely with MD Anderson and several other cancer partners to discover and validate signatures for the assays. Because the commercialization portion of the alliance lies with Veridex, Padukone declined to discuss a marketing timeline.
He also declined to comment on whether the firms plan to submit the assays for US Food and Drug Administration clearance or if they will be made available as laboratory-developed tests via a central testing laboratory.
Raritan, NJ-based Veridex has its own ambitions in the breast cancer diagnostics market, and those goals made the Nuvera deal possible. The company's GeneSearch Breast Lymph Node Assay is designed to help inform treatment decisions by detecting cancer metastases, and its CellSearch Circulating Tumor Cell Test is a blood-based assay designed to determine the prognosis of patients with metastatic breast, colorectal, or prostate cancer.
In the past, Veridex has also discussed developing diagnostic assays for breast and colorectal cancer on Affy’s array platform (see BAN 2/28/2006). The company, though, has not provided an update on these assays in recent years.
Veridex did not respond to an e-mail seeking comment for this article.