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Breast cancer Dx beyond borders
July 2009
by Lori Lesko  |  Email the author
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PARIS—ExonHit Therapeutics has licensed the exclusive worldwide rights from the Institut Gustave Roussy (IGR) for a novel breast cancer diagnostic assay through FNA (fine needle aspiration) sampling. Signed May 27, this license agreement, covering IGR's tissue-based breast cancer signature, strengthens ExonHit's diagnostic pipeline and paves the way to future development and commercialization opportunities.

IGR, based in Villejuif, France, pioneered the routine use of FNA in place of the more invasive core biopsy, says Prof. Gilles Vassal, head of Clinical and Translational Research at IGR. The assay that ExonHit plans to develop could improve the accuracy of FNA, thus opening the door to more medical centers using the less invasive—and less expensive—diagnostic procedure.

Breast cancer is the leading cause of death by cancer in women, with 465,000 estimated deaths worldwide in 2007. Early detection of breast cancer significantly increases survivorship. If this collaborative venture is successful, a highly accurate diagnostic test for breast cancer will be as invasive as a pinprick.

Assuming successful clinical validation, ExonHit, headquartered in Paris with a U.S. office in Gaithersburg, Md., will first launch the test as a research use-only product within 12 months, the company says. Then, following further validation, the test will be launched as a clinical diagnostic.

In return, IGR will receive an upfront payment, as well as development milestones and royalties on future sales. Detailed financial terms were not disclosed.

IGR, in collaboration with the CNRS unit FRE 2939, identified a novel breast cancer signature, with an accuracy of more than 95 percent, based on ExonHit's proprietary SpliceArray platform, according to an article published Feb. 26 in Lancet Oncology. This new signature allows for the discrimination between malignant tumors and benign lesions from cells sampled through FNA. The research was conducted by Dr. Fabrice Andre and his team at the IGR, starting with 165 breast samples obtained by fine needle aspiration.

The results of the study left Andre cautiously optimistic.

"Many exons are differently expressed by breast cancer and benign lesions, and alternate transcripts contribute to the molecular characteristics of breast malignancy," Andre wrote in the Lancet article. "Development of molecular classifiers for breast cancer diagnosis with fine-needle aspiration should be possible."

Typically, if a breast abnormality is detected with mammography or physical exam, a woman will be referred for additional breast imaging with diagnostic mammography, ultrasound or other imaging tests. Depending on the results of these follow-up tests, she may be referred for fine needle aspiration (FNA) or a breast biopsy to confirm whether the tissue change is malignant or benign.

Unlike a biopsy, FNA is a quick procedure performed in an outpatient clinic, Andre says. Using a very thin needle and syringe, the doctor removes either fluid from a cyst or clusters of cells from a solid mass, then sends it to a laboratory for microscopic analysis to see if any cancer cells are present. Should the FNA results be uncertain, the diagnosis is pursued with a surgical biopsy or exploratory surgery.

Isabelle Pelletier-Bressac, general manager of IGR&D, the tech transfer affiliate of IGR, says, "ExonHit is essential to the Institut because ExonHit possesses the IP around the splice array technology. And since the diagnostics is based on splice array, they are the best candidate to develop and market the technology."

Dr. Loïc Maurel, president of ExonHit's management board, stated in a press release, "The license of such a promising signature for breast cancer diagnosis is in line with our strategy to reinforce our diagnostic portfolio with simple, accurate and patient-friendly tests. As our first non blood-based diagnostic, this is a different and complementary approach to our ongoing cancer diagnostic programs with BioMérieux."

This signature may be used for all cases where FNA sampling is performed and is especially useful for "gray zone" cases where FNA results are inconclusive and either a surgical biopsy or an exploratory surgery is required to get a definitive answer. Today, it is estimated that a cytologist is unable to provide a definitive diagnosis in 10 to 20 percent of cases where FNA samples are taken. ExonHit aims to better the odds.

More accurate diagnostics of a disease help ensure more effective treatment outcomes, saving lives and money, Maurel told Reuters. It takes two to four years to develop a diagnostics test, compared with 10 years for a drug.

Each year, an estimated 370,000 FNA procedures are performed in Europe, but no hard and fast figures on the number of FNA procedures in the United States are readily available, Andre says.

If ExonHit marches forward as planned, women worried about breast cancer and frightened of exploratory surgery, can rest assured: FNA is coming to America, he says.

"Our focus is on the United States, but we are not at all closing the door for Europe," Maurel told Reuters. "ExonHit has an office in Gaithersburg, Md., in the United States, and its foothold in the world's biggest drug market will facilitate its expansion."
 

 
Will bad times for hospitals mean trouble for diagnostics industry?

NEW YORK—Hospital industry woes may be a concern for the $47 billion in vitro diagnostic industry, according to a new report from healthcare market research publisher Kalorama Information.

The report, In Vitro Diagnostics in a Recessionary Economy: IVD Market Forecasts, Analysis and Success Strategies, predicts that with the key purchasers of in vitro diagnostics equipment and reagents facing cash crunches, reduced patient admissions and unpaid bills, growth for diagnostic companies will be more challenging over the next few years.

Recent economic conditions have been rough for the hospital industry, the report notes. Many hospitals and health systems have seen stock portfolios shrink and have had a difficult time obtaining credit to finance operations. A new survey from the American Hospital Association indicated that the majority of hospitals are seeing a moderate or significant decline in their financial health in 2009 versus the same period in 2008. Forty percent of hospitals expected losses in the first quarter of 2009. Recent employment information from the Bureau of Labor Statistics confirms that hospital employment is no longer growing, and that the number of mass layoffs for hospitals reported in February was more than double what it was a year ago. Six out of 10 hospitals nationally are seeing a greater proportion of patients without insurance coming through their emergency departments.

"The health of the hospital industry is obviously related to the success of the diagnostic industry, and right now its health is not good," says Shara Rosen, lead diagnostics analyst for Kalorama Information and author of the study. "Hospital financing is in jeopardy, income is down and cash is strained. For the IVD industry, this could mean fewer purchasers of equipment and reagents."

According to Rosen, consolidation is also possible since weaker hospitals may not survive and will be acquired, while larger hospitals will seek to acquire smaller entities instead of paying to expand existing facilities. Such consolidation will further erode the customer base for diagnostic products.

Still, while the rough patch for hospitals may thwart grandiose expansion plans and intimidate new entrants, Rosen predicts steady, but modest, growth, and notes that the industry still has a lot going for it. There has already been downsizing and cost cutting in the industry, and government programs and emerging markets will balance out downward sales to some extent.

"So much of the IVD market is still critical to the basic investigation of a disease that it's hard to imagine a cutback in those core areas," Rosen says.
 
Code: E070928

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