Asuragen may have launched its first microRNA-based diagnostic earlier this year, but the company has decided to wait until November to kick off a formal marketing campaign as it conducts additional validation work, a company official told RNAi News this week.
Asuragen announced in late April that the test, which is designed to differentiate pancreatitis from pancreatic ductal adenocarcinoma in either frozen or formalin-fixed, paraffin-embedded tissue samples, would become available in May (see RNAi News, 4/24/2008).
And while the test is available to clinicians who contact the company, Asuragen has been quiet about it, not even publicizing it on its website. But according to Carol Berry, vice president and general manager of Asuragen Pharmacogenomic Services, this is set to change next month when the company expects to wrap up work validating the test in tissue obtained through fine-needle aspiration.
Berry said that Asuragen decided to introduce the test in its current form earlier this year because of “tremendous interest” from clinicians, as well as strong data from a validation study of 60 frozen clinical samples in which it showed a sensitivity of 95.2 percent and a specificity of 94.9 percent
At the same, she said, “we wanted to … translate [the product] into a fine-needle aspirate-type test. We’re in the midst of validating that [work] with a clinical partner.” She declined to name the partner.
Once that work is complete, the company expects to begin a significant marketing push, which will include promoting it at the Association of Molecular Pathology annual meeting, which begins in late October, Berry said.
Berry confirmed that Asuragen intends to continue offering the diagnostic through its own CLIA-certified laboratory.
Asuragen’s efforts to prepare the pancreatic cancer diagnostic for use with fine-needle aspiration specimens will contribute to a significant body of data in this area that the firm has already accumulated.
In June, researchers from Asuragen presented data at the Joint Meeting of the European Pancreatic Club and the International Association of Pancreatology showing that differentially expressed miRNAs in both FFPE and fine-needle aspiration biopsies of pancreatic ductal adenocarcinoma could be used to distinguish between malignant and benign disease.
“We wanted to … translate [the product] into a fine needle aspirate-type test. We’re in the midst of validating that [work] with [an undisclosed] clinical partner.”
According to the abstract from the presentation, “expression analysis of a few specific miRNAs enabled segregation of PDAC specimens from chronic pancreatitis and normal pancreas tissue specimens … [indicating] that miRNAs in combination with [a fine-needle aspiration] biopsy procedure could aid pathological evaluation of suspicious cases and become a valuable asset in definitive diagnosis of pancreatic ductal adenocarcinoma.”
Earlier this year at the University of Miami’s Winter Symposium, which focused on regulatory RNA in biology and human health, Asuragen researchers and collaborators presented data showing that altered expression of miR-217 and miR-196a could be used to distinguish benign pancreatic tissue samples from malignant ones obtained through fine needle aspiration.
According to that data, 13 patients with suspected pancreatic masses underwent endoscopic fine-needle aspiration biopsies, while normal pancreatic tissue specimens were collected ex vivo from resected pancreases.
“We observed that the quantitative expression analysis of selected miRNAs and mRNAs in PDAC and normal pancreas [fine needle aspiration] samples correlated well with the changes observed in respective frozen tissue samples,” the investigators wrote in a poster presented at the symposium. “In addition, we verified that altered expression of miR-196a and miR-217 enabled clear segregation of PDAC [fine needle aspiration] specimens from non-malignant … samples.”
miRNA Dx Space Heats Up
Although Asuragen hit a major milestone by being the first to get its miRNA diagnostic to the market, the company won’t be alone for long as peers Rosetta Genomics and Exiqon prepare to launch their own diagnostics this year through their own recently acquired CLIA labs.
Rosetta has perhaps the broadest miRNA diagnostic pipeline of all the major players in the space, with at least nine products under development.
The company’s most advanced test, miRview Squamous, is designed to differentiate squamous from non-squamous non-small cell lung cancer, and was cleared for sale by the New York State Department of Health Clinical Laboratory Evaluation Program in July (see RNAi News, 7/24/2008). It is slated for commercialization this year.
Two other tests, one for determining the source of cancers of unknown primary origin, called miRview Mets, and one for differentiating lung cancer from mesothelioma, called miRview Meso, are set for introduction next year.
Diagnostics for predicting response to ovarian cancer treatment, for gauging the risk of gastric cancer recurrence, and for differentiating small from non-small cell lung cancer are expected to reach the market in 2009 and 2010.
The newest additions to Rosetta’s development-stage diagnostic lineup are tests designed to detect colon cancer by using an miRNA signature that can be identified in blood serum; a test designed to determine the risk of bladder cancer becoming invasive; and one created to predict the risk of colon cancer recurrence. The company has not said when it plans to debut these products.
Exiqon, meanwhile, is developing miRNA-based diagnostics that will replace a line of cellular-based extreme drug resistance tests for a variety of cancers, including colon, breast, ovarian, and lung, that were developed by oncology-testing services provider Oncotech, which Exiqon acquired early this year (see RNAi News, 4/10/2008). The company is also developing a test for determining the source of cancers of unknown primary origin.
Exiqon aims to have its first diagnostic on the US market this year, but has yet to disclose its indication.