Going under the needle

Asuragen launches multi-center collaboration for development of diagnostic test for pancreatic cancer

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AUSTIN, Texas—Asuragen Inc., a provider of molecular diagnostics and RNA-based pharmacogenomics services, recently announced a broad-ranging research partnership that brings together the University of Pittsburgh Medical Center, Brigham and Women's Hospital, the H. Lee Moffitt Cancer Center, Dartmouth's Hitchcock Medical Center and the University of Sherbrooke to develop a microRNA-based diagnostic test to aid the detection of pancreatic cancer from fine-needle aspirate (FNA) biopsies.

Asuragen's Dr. Bernard Andruss, director of collaborations and business development, explains that his company has established itself as a leader in microRNA research and diagnostics, and has honed its direction into the oncology space. He says that the company's broad base of intellectual property and experience in biomarker discovery leading through to commercial launch of products made Asuragen an attractive partner to the academic community in this path-breaking venture.

The collaborative sites will provide clinical expertise and samples to help Asuragen evaluate the clinical utility of a microRNA (miRNA) test based on FNA biopsies to distinguish pancreatic adenocarcinoma from chronic pancreatitis and other non-cancerous conditions. These studies will be used to expand Asuragen's current pancreatic cancer test program.

Asuragen is a spinoff of Ambion Inc., a Texas company which made progress in the microRNA field. Scientists from Ambion's molecular diagnostic and pharmacogenomic service division, with expertise in miRNA applications and assay development, have helped the company make a name for itself in the areas of clinical diagnostic products and services.

Asuragen is a fully integrated molecular diagnostic company focused on personalized medicine and companion diagnostics, with emphasis on miRNA applications in oncology. In addition, it provides biomarker discovery and profiling services, assay development and validation services, among others. Asuragen's expertise spans the spectrum from discovery to production to commercialization.

The diagnostics business was primarily working within the cystic fibrosis area, but then turned to the oncology space and ventured into pharmacology just before Asuragen's launch.

The company introduced the world's first miRNA-based diagnostic test in 2008, which aids in the diagnosis of pancreatic cancer in formalin-fixed specimens. The FNA-based pancreatic cancer test is expected to be made available in Asuragen's CLIA laboratory in the second half of this year.

Andruss says the partnership will provide about a dozen biomarkers to his company to perform testing for the early detection of pancreatic cancers. Potentially, in the future, it could prove useful to the medical community in earlier diagnosis of not only cancer, but also be a tool for diagnosis of pancreatitis and other non-cancerous conditions of the abdomen.

Dr. David Whitcomb, chief of the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh Medical Center, says, "More accurate diagnosis of pancreatic adenocarcinoma using FNA samples will improve the clinical decisions in cases of suspected pancreatic cancer and help improve the management of patients for which conventional cytopathology is indeterminate."

According to Andruss, at present, current testing for pancreatic disease uses tissue removed surgically, giving a patient a diagnosis after that invasive procedure is endured. It is estimated that between five and 25 percent of patients are left with an inconclusive result after that diagnostic testing.

Pancreatic ductal adenocarcinoma is the most prevalent form of pancreatic cancer and one of the most deadly cancers. Survival rates are low due to the lack of early detection and the lack of effective therapies. Asuragen's miRNA test currently uses formalin-fixed biopsy or resection specimens and detects miRNAs that can distinguish pancreatic cancer from benign chronic pancreatitis.

This test is intended to provide valuable information to physicians to resolve cases for which standard cytopathology results are inconclusive, which can often occur in pancreatic diseases. These research collaborations will help Asuragen evaluate the potential clinical utility and diagnostic performance of miRNAs for diagnosing pancreatic cancer using FNA biopsies, which can be obtained less invasively and may allow patients to avoid unnecessary surgery.

"It's difficult for pathologists to make a determination," he says. "Sometimes, there is not enough material, or the sample does not fit the definition conclusively. By using fine needle aspirations of the lesions, the future will hold a better chance of using our testing to provide better diagnostics to physicians to make better diagnoses, leaving fewer patients in the indeterminate phase."

Dr. Darwin Conwell, associate professor of medicine at Brigham and Women's Hospital, says, "The recent data using miRNA in pancreas cancer is promising. We are pleased to participate in this multi-center study to enhance the diagnosis of pancreas cancer using recent advances in molecular biology. It is our hope that this study will clarify the diagnosis and help direct treatment strategies of our patients."

The complete partnership includes Brigham and Women's Hospital, Dartmouth's Hitchcock Medical Center, the University of Pittsburgh Medical Center and the H. Lee Moffitt Cancer Center of Tampa.

Dr. Shivakumar Vignesh, associate professor of oncologic sciences, says he is excited about the Asuragen partnership, saying that it will build on expertise developed at his institution, the Moffitt Cancer Center.

"Asuragen wanted to validate some of their research with a large scientific institution, and we have a good accrual of patient data," Vignesh says.

Vignesh says the partnership has been underway for about a year, if the start-up paperwork is considered.

"It takes about six to eight months to get everything underway," Vignesh points out. "We have a goal of obtaining samples from about 100 patients and have about a dozen now. We think from our side that this phase will continue through 2010. Right now, it's going well; the data collection is on cruise control. This is a good partnership to be part of."

Companies set sights on early detection of deadly pancreatic cancer

By Amy Swinderman

ATLANTA—When it comes to the difficult-to-diagnose disease of pancreatic cancer, the companies and institutions we report on in this page are seeking the holy grail: new diagnostic tests for the early detection of this fatal disease, which is hard to find because the pancreas is hidden behind other organs and not readily felt in routine exams.

According to the American Cancer Society, pancreatic cancer, which affects about 38,000 people a year, has a 5 percent survival rate for five years if it is caught in its advanced stages. Caught early enough and treated with surgery and chemotherapy, the five-year survival rate goes up to 17 to 25 percent.

The world's oldest and largest private cancer center, Memorial Sloan-Kettering Cancer Center (MSKCC), estimates that only about 20 percent of pancreatic cancers are diagnosed while the tumor is confined entirely within the pancreas.

Renowned research university Johns Hopkins notes that pancreatic cancer often presents clinically with non-specific signs and symptoms such as pain, jaundice and weight loss. In these situations, the diagnosis of pancreatic cancer may not be suspected—and even when it is, pancreatic cancer can be difficult to detect and diagnose. A variety of techniques can be used to establish a diagnosis. These techniques include CAT scan, endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP).

Although all of these imaging techniques may reveal a suspicious mass in the pancreas, the "gold standard" for diagnosing pancreatic cancer remains histopathology, according to Johns Hopkins. Tissue for microscopic examination can be obtained by fine needle biopsy, by tissue needle cone biopsy or by excisional biopsy at the time of laparotomy. Angiography is useful to determine if the vessels around the pancreas are involved by the tumor and a blood test (CA19-9) can be useful in following the effectiveness of treatment.

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