UB Researchers Have Developed and Validated a New Diagnostic Test for Chronic Sinusitis

The new test will provide chronic sinusitis patients with a definitive diagnosis for the first time

Clinical studies conducted at the University at Buffalo School of Medicine and Biomedical Sciences have completed the clinical development of the first immunologic test for diagnosing chronic rhinosinusitis.

The new test, which is being launched this month nationwide by Immco Diagnostics of Amherst, N.Y., makes it possible, for the first time, to definitively diagnose the condition. Immco Diagnostics licensed the test from the Mayo Clinic, where the researchers, who later joined UB, first developed and patented it.

“This is a game-changer,” says Jens U. Ponikau, MD, clinical assistant professor of otolaryngology at UB, who led the university’s clinical trials on the new test with David A. Sherris, MD, professor and chair of the UB Department of Otolaryngology, and Kishore Malyavantham, PhD, of Immco. “It provides physicians with a way to precisely identify what kind of inflammation is present in the nose and can help guide their treatment wp-contentroach.”

Chronic rhinosinusitis is one of the most common chronic diseases in the U.S., with more than 30 million sufferers, about 14 percent of the population. There are no wp-contentroved drugs or treatments that target chronic rhinosinusitis, mainly, Ponikau says, because physicians have not had sufficient insight into what causes it.

“The symptoms for chronic rhinosinusitis include long-term nasal congestion, thick mucus, headache, loss of sense of smell and opportunistic bacterial infections, most of which are similar to other common conditions,” Ponikau says. “So is it a year-round allergy, a deviated septum, the common cold, some recurrent bacterial infection or chronic sinusitis? Until now, there were few ways to tell.”

Some patients have even undergone endoscopic surgery in hopes of getting some relief, but often the disease comes back after surgery, he says.

While working at the Mayo Clinic, Ponikau and Sherris made the discovery that chronic rhinosinusitis (CRS) is an immunologic condition in which rare white blood cells called eosinophils travel through the nasal skin into the mucus, where they release a toxic protein called major basic protein (MBP), damaging tissue and causing symptoms.

The Mayo Clinic patented the discovery as a clinical test and Ponikau and Sherris brought the research to Western New York when they were recruited to UB in 2003 to reestablish its program in otolaryngology, a specialty focusing on the ear, nose and throat.

“The major basic protein is specific only to chronic rhinosinusitis and does not wp-contentear in acute sinusitis, allergy or the common cold,” explains Ponikau, “but we and researchers at other centers around the world had to confirm this.”

“Patients afflicted with CRS show a specific kind of airway inflammation, which is usually not caused by bacterial infection,” says Lakshmanan Suresh, PhD, clinical associate professor in the Department of Oral Diagnostic Sciences in the UB School of Dental Medicine and vice president of R&D and clinical services at Immco. “Our CRS test shows inflammation elicited due to fungus and is helpful in identifying patients where antibiotic therapy may not be helpful.”

In February, the New York State Department of Health provided regulatory wp-contentroval for the test to measure MBP in nasal mucus.

The test can be performed in a physician’s office. A sample of nasal mucus is taken from a patient and is then sent to Immco Diagnostics for analysis, which will typically take a few days.

Physicians who want to obtain the test should contact Dr. Suresh at Immco at 716-691-0091 ext. 312 or ext. 149.

Ellen Goldbaum (UB); goldbaum@buffalo.edu; 716.645.4605

Roswell Park's Center for Personalized Medicine

center-personalized-medicine-press-conference.2013-01-30-35Roswell Park Cancer Institute‘s (RPCI) new 5,000-square-foot facility, the Center for Personalized Medicine (CPM), will provide individualized therapies for patients through genetic code sequencing (an analysis of genomes – the entire inherited genetic makeup of humans). Using state-of-the-art, next-generation technology, advanced research has led to the identification of unique genetic characteristics that will help determine effective and custom treatments for patients with certain diseases. Utilizing high-throughput screening for drug discovery, personal gene sequence machines and a 1,600-processor supercomputing cluster, the RPCI team will efficiently be able analyze individual genome data.
Located within RPCI’s Center for Genetics & Pharmacology, the Center will also act as a resource for scientists and medical providers to use for national clinical care wp-contentlication. In addition to having a mobile unit, the CPM is the first regional resource for next-generation gene sequencing to have met federal Clinical Laboratory Improvement Amendments (CLIA) requirements.

At the end of  last year, RPCI was awarded a $5.1 million grant to begin the pilot phase of the genome project from Governor Cuomo’s Regional Economic Development Council, established to promote regional economic development. Since then, RPCI has garnered an additional $18.5 million in investments to support the project. From RPCI, $16 million has been invested in equipment and infrastructure, and Computer Task Group (CTG), a Buffalo-based national leader in healthcare IT, has committed to $2.5 million. As a local and nearby partner, CTG will provide its healthcare and bioinformatics expertise to deliver personalized medicine quickly and cost-effectively. The University at Buffalo, IMMCO Diagnostics and Western New York Urology Associates LLC are additional supporters of the project.

Candace Johnson, PhD, Deputy Director of the CPM stated that “We now have the ability to do robust, ‘next-generation’ gene sequencing on blood and tissue samples, with tremendous possibilities in terms of what we can learn diagnostically, prognostically, therapeutically.” Johnson also stated that personalized medicine is the future, not just for oncology patients but for treatments across all diseases.

The CPM is a prime example of the type of support that Cuomo’s Council looks to provide for organizations throughout the region to capitalize on resources and developments that will support the local economy by creating more jobs and economic growth. Recognizing the growth hwp-contentening on the Buffalo Niagara Medical Campus and throughout the region, Cuomo stated that “Western New York has a thriving health and life sciences industry cluster, which the Western New York Regional Economic Development Council and Roswell Park Cancer Institute recognized. Through the Regional Council process, they created a custom-tailored plan to take advantage of this opportunity, which will rebuild the regional economy.”

center-personalized-medicine-press-conference-2013-01-30-34RPCI’s President and CEO, Dr. Donald Trump captured the significance of the Center’s presence. He stated that “The doors are wide open in terms of the opportunities for entrepreneurship and technology transfer that will flow from [the Center].” The CPM team, partners and supporters increase RPCI’s menu of services, giving the institution the opportunity to contend with other small circle healthcare organizations providing similar medical services.

Immediately on the agenda, the CPM will undertake its first 3 sequencing projects, clinical research studies that will:

  • Predict on a case-by-case, personalized basis which of the two main types of standard chemotherapy, anthracycline-based or platinum-based, will be most effective in treating a woman’s breast cancer, and with fewest adverse side effects;
  • Develop, in collaboration with Western New York Urology Associates, a diagnostic test for superficial bladder cancer, the ninth most common cancer in the U.S. and the most expensive of all cancers in terms of cost to treat; and
  • Engage 600 healthy volunteers representing the ethnic, racial, socioeconomic and geographic diversity of the eight-county Western New York region in an initiative to identify the particular healthcare priorities of this community, aided by a mobile tissue-collection unit that will travel to disparate and underserved areas.
  • In addition, RPCI expects to use the resources of the CPM in planning individualized care for its lung, melanoma and leukemia patients in the near future.

Read more about the CPM below:

Roswell Launches Center for Personalized Medicine

Groundbreaking Cancer Research Hwp-contentening in Buffalo

Progressive Medicine is Roswell’s Newest Venture

 

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