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Rosetta Sees Registry Data Boosting Cancer Origin Test, Readies Thyroid Cancer Assay


NEW YORK (GenomeWeb) – Despite posting a more than 200 percent jump in revenues for 2014 on increased sales of its flagship test for determining the tissue of origin for primary and metastatic tumors, Rosetta Genomics continues to face difficulties building demand for the product, company officials said today.

However, the firm expects that the publication later this year of initial data from a patient registry study designed to show that the assay, dubbed the Cancer Origin Test, can successfully guide treatment decisions will bolster its efforts to open up the market.

Meanwhile, Rosetta continues to prepare for the commercial launch of an assay for the differential diagnosis of indeterminate thyroid fine-needle aspirate (FNA) samples later this year, which it believes holds a key advantage over competing products already on the market.

The Cancer Origin Test analyzes the expression of 64 microRNAs to identify 49 cancer origins and is currently Rosetta's top-selling diagnostic. During a conference call held today to discuss the company's 2014 financial results, Rosetta CFO Ron Kalfus noted that the test accounted for 97 percent of total product revenues last year.

And although revenues more than tripled year over year to $1.3 million, Rosetta President and CEO Kenneth Berlin acknowledged that this growth came off of a "modest base" of $405,000.

"Right now, the market hasn't converted very well," not only for the Cancer Origin Test, but also for similar products, he said during today's call. Rosetta's in-house sales team has made strides in raising awareness for the test, he added, but an ongoing point of resistance for product uptake is a lack of data supporting its use.

To address this, last year Rosetta kicked off a two-part study to collect from clinicians outcome data on roughly 400 patients diagnosed with primary or metastatic cancer of unknown origin and diagnosed with the Cancer Origin Test, as well as to track treatments selected, duration of response to therapies, survival, and other clinically relevant information.

Early data from this study, Berlin said on the call, are "very promising, with over two-thirds of respondents stating the result was reliable and clinically impactful."

Further, treatment plans for over 40 percent of the tested patients in this study were changed based upon the Cancer Origin Test results, he said. "That is a significant number of cases where our test has had a meaningful impact on treatment decisions."

Results from the first portion of the registry study are slated for publication later this year. "We believe these types of publications, demonstrating the value of our Cancer Origin Test, will help us increase our penetration in the … market," Berlin added.

The company is also putting the final touches on its miRNA assay for differentiating malignant from benign thyroid nodules.

According to Rosetta, nearly 500,000 FNAs of thyroid nodules are performed in the US, and roughly 750,000 are performed in Europe, each year.

"Interpretation of FNA samples is not always straightforward, leading to an indeterminate result in up to 30 percent of the samples," Berlin said. "The current thinking is, 'When in doubt, take it out.' But as many as 80 percent of these excised thyroids turn out to have only benign lesions, resulting in many unnecessary surgeries.

A handful of companies already have products on the market to rule out cancer in thyroid nodules deemed indeterminate by standard cytology. These competitors include Veracyte, which markets the Afirma Gene Expression Classifier, and Interpace Diagnostics, which sells the ThyGenX Thyroid Oncogene Panel.

Still, Berlin sees Rosetta's test as having the same overall accuracy as competing products such as Affirma and ThyGenX, but with one key advantage. Because Rosetta's test will analyze the same FNA specimens used to make an initial diagnosis, "we eliminate the risks and morbidity associated with a second fine needle passage into the patient's neck," he said.

"Rosetta's … approach ensures that the questionable thyroid cells are interrogated by molecular analysis utilizing our proprietary microRNA platform," Berlin stated. "The competitors use of separate additional FNA passes may result in the molecular interrogation of the wrong cells, cells that are different than the ones used in the initial cytopathological workup, leaving the potential for misdiagnosis."

He added that other companies in the field have helped to already establish a market for such products and collectively generated about $50 million in revenues last year.

The final validation study for its thyroid neoplasia test is underway, with commercial launch expected in the third quarter, Berlin noted.