Rosetta Genomics this week announced the launch of its third microRNA diagnostic, achieving its long-stated goal of introducing three tests based on the small non-coding RNAs before the end of 2008.
A company official also last week disclosed pricing information and revenue guidance for the three products, and said that Rosetta is actively seeking marketing and distribution partners to speed their adoption in the US and overseas.
The newest test, called miRview Meso, differentiates lung cancer from mesothelioma. Last week, Rosetta had announced the availability of miRview Mets, its second miRNA diagnostic, which is designed to determine the source of cancers of unknown primary origin.
By analyzing the expression levels of 48 miRNA biomarkers, miRview Mets is capable of identifying 25 different tumor types from a variety of tissue origins, including colon, brain, breast, kidney, liver, lung, ovary, pancreas, prostate, and testis, Rosetta said.
“The test then uses a proprietary classifier to assign a primary site to the tumor based on the microRNA expression in the sample,” Rosetta President and CEO Amir Avniel said during a conference call held last week.
Earlier this year, researchers from Rosetta published data in Nature Biotechnology describing the classifier and showing how that miRNA collection could be used to pinpoint the origin of cancers of unknown primary with around 90 percent accuracy (see RNAi News, 3/27/2008). According to Rosetta, miRview Mets predictions reach 90 percent sensitivity with 99 percent specificity in most cases.
Avniel said that miRview Mets is being sold for $3,650. MiRview Meso and miRview Squamous, which is designed to differentiate squamous from non-squamous non-small cell lung cancer and was introduced earlier this month (see RNAi News, 12/11/2008), are being sold for $3,170 each.
According to Avniel, Rosetta expects that these three products will generate revenues in the range of roughly $5 million to $9 million in 2009 based on the approximately 2,000 tests the company said it expects to sell during the year. However, he cautioned that since “there is no other microRNA-based molecular diagnostics company with three tests available, it is extremely difficult to benchmark ourselves in order to produce accurate [revenue] projections.”
Also confounding Rosetta’s efforts to project sales of its diagnostics is uncertainty surrounding future insurance reimbursement for the tests.
“We feel the best model for us is to develop the tests and collaborate with a well-established partner on commercialization. But of course, we cannot provide any assurance that we will be able to enter into such a partnership on reasonable terms or at all.”
“As our miRview tests have just been released, they are currently not covered by insurance companies,” Avniel noted. “However, we are fully aware of the importance reimbursement has on market adoption of diagnostics. It is our intention to seek reimbursement for the tests as soon as possible at a level that will reflect the medical and economic value our test brings to the market.”
He added that, as part of its market research efforts, the company has provided details about the miRview tests to “several medical directors from the country’s leading payers. The overall feedback we received was very positive with regards to both the need for [the] objective solution that our tests offer, as well for the tests’ reimbursement potential,” Avniel said.
Meanwhile, Rosetta is on the lookout for partners that can assist in marketing the miRview tests both domestically and internationally.
“We are currently in discussions with several potential partners” about US marketing arrangements, Avniel said during last week’s call. “At this point in time, we feel the best model for us is to develop the tests and collaborate with a well-established partner on commercialization. But of course, we cannot provide any assurance that we will be able to enter into such a partnership on reasonable terms or at all.”
Additionally, the company is seeking “distributors and partners to market our testing services in Europe, Canada, and Japan,” he said. He added that since all of the tests in Rosetta’s current diagnostic lineup use formalin-fixed, paraffin-embedded tumor samples, which do not require temperature-controlled shipping, they “should be attractive to markets outside the US.”
Although Avniel did not provide details on any potential partnerships, he indicated that Rosetta may ink at least one deal within the first half of 2009. But the company isn’t waiting for a partner to get the ball rolling when it comes to marketing its diagnostics.
Ronen Tamir, Rosetta’ chief commercialization officer, said during the conference call that the company has made the tests available through its website, and has already shipped out the first diagnostic kits to physicians.
At the same time, Rosetta is ramping up a direct mailing initiative “that will allow us to make the medical community know these tests are available … [as the company talks with] a few opinion leaders directly in order to gain their support and have them order the tests,” Tamir said.
In response to an analyst’s question during the conference call, Avniel declined to specify whether the company’s diagnostic revenue guidance assumed it had secured one or more commercialization partnerships.
miRview of the Future
As it addresses the challenges of commercializing its diagnostics, Rosetta is also maintaining a focus on advancing new tests through its pipeline.
“We have leveraged our proprietary technologies to identify several new microRNA-based diagnostic leads,” Avniel said last week. “We intend to utilize the same development engine that has allowed us to advance our [first] three products in a relatively short period of time to transform these new leads into commercially available tests in the years ahead.”
This summer, the company announced that it had expanded its stable of miRNA diagnostic candidates to include a blood-based test to detect the presence of colon cancer, as well as ones to assess the risk of superficial bladder cancer becoming invasive and to predict the risk of colon cancer recurrence (see RNAi News, 8/21/2008).
And in June, the company said that it had begun developing tests to predict responses to ovarian cancer treatment, to gauge the risk of gastric cancer recurrence, and to differentiate small from non-small cell lung cancer (see RNAi News, 6/19/2008).