SALEM, Mass., Oct. 13, 2015 /PRNewswire/ -- Commonwealth Laboratories, LLC ("Commonwealth") announced today that it has formed an agreement with Quest Diagnostics ("Quest") that will expand the availability of IBSchek™, a new laboratory developed blood test designed to help physicians quickly and reliably diagnose Irritable Bowel Syndrome (IBS).
Under the agreement, clinicians will be able to order blood draws on patients for testing through Quest's approximately 2,200 patient service centers and 4,000 phlebotomists in physician offices in the United States. Specimens will be forwarded to Commonwealth's CLIA-certified clinical laboratory in Salem, Mass., for testing.
Launched in May 2015, IBSchek is a clinical laboratory test designed to aid in the diagnosis of IBS, the most common gastrointestinal disorder in the U.S., affecting approximately 40 million Americans.1
"This new relationship with Quest marks another significant step forward in the continued growth plan for Commonwealth and represents one of the many great strides that our company has made since the launch of the IBSchek test earlier this year," said Craig Strasnick, Chief Operating Officer at Commonwealth. "This agreement expands the availability of the test exponentially for the nearly 40 million patients1 suffering from IBS in the United States by allowing for far greater and more convenient access to IBSchek to aid in the quick and efficient diagnosis of IBS. Additionally, with Quest now a preferred partner of Commonwealth, we are looking forward to driving increased awareness about the clinical utility and overall impact of this new, innovative technology."
Prior to the introduction of IBSchek, a diagnosis of IBS was typically made only after excluding all other conditions, such as Crohn's disease and ulcerative colitis. This process could require patients to undergo costly and invasive procedures. It would typically take an average of five years and prolonged suffering before patients would receive a diagnosis of IBS.2
"Our relationship with Commonwealth will enable a far greater number of patients to access the IBSchek test, an important medical innovation for aiding the diagnosis of IBS, a disorder that is prevalent and a challenge to diagnose," said Patrick Plewman, General Manager for Infectious Disease and Immunology. "IBSchek complements and extends Quest's broad menu of tests for autoimmune and gastrointestinal disorders, such as Celiac Disease, designed to provide insights in aiding reliable diagnoses. It also allows Quest to generate greater value from our service network, which is the largest in the diagnostic industry."
Commonwealth launched IBSchek in May 2015 during Digestive Disease Week, the world's leading educational forum for those working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery and related fields. IBSchek uniquely addresses the needs of IBS patients suffering with GI discomfort by confirming the presence of two IBS antibodies which, if present at certain levels, help the clinician to diagnose IBS. IBSchek uses a well established immunoassay method called ELISA that can be conducted on a specimen collected via a standard blood draw. Results are reported to the physician within 24 hours of the patient's blood specimen being received by Commonwealth for analysis. More information on IBSchek can be found at www.IBSchek.com.
IBS is the most common gastrointestinal disorder in the U.S., affecting nearly 40 million Americans. IBS affects approximately 15% of the U.S. population. It is more common in women than in men, and the symptoms can be very difficult to diagnose.1
About Commonwealth Laboratories, LLC
Headquartered in Salem, Massachusetts, Commonwealth Laboratories, LLC is a state and federally licensed, FDA-registered, independent diagnostic laboratory offering specialized diagnostic tests to aid in the diagnosis of a variety of functional gastrointestinal disorders. The company executes a service-based approach and its core philosophy is to create customized operational solutions aimed at accessibility and simplicity in diagnostics. Commonwealth's scalable, efficient and clinically sophisticated platform provides the resources healthcare providers need to quickly and accurately make an informed diagnosis for their patients.
For more information about IBSchek™, please call (877) IBS-CHEK (427-2435) or visit http://www.IBSchek.com. For information regarding any other services provided by Commonwealth, including its hydrogen and methane breath testing platform for Small Intestinal Bacterial Overgrowth (SIBO) and carbohydrate malabsorption disorders, please call (800) 292-9019, visit www.hydrogenbreathtesting.com, or email [email protected].
IBSchek™ is based on the scientific findings of Mark Pimentel, MD, which showed that anti-vinculin and anti-CdtB are effective biomarkers for the diagnosis of IBS. The test utilizes a proprietary, ELISA-based blood test, providing results within 24 hours of sample receipt at Commonwealth. Its turnkey approach is office-friendly and assists in supplying healthcare providers with the objective data they need to make an informed diagnosis, while also providing validation for the symptoms and associated discomfort that patients have been experiencing for extensive periods of time.
Additional resources, including company and IBSchek product logos, an infographic and a video of how IBSchek works can be found in our Digital Newsroom.
IBS is a gastrointestinal disorder in which symptoms are due to dysfunction of the gut. There are three different types of IBS, with an equal number of people in each category: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and IBS with alternating constipation and diarrhea (IBS-M). The symptoms associated with IBS-C include stomach pain and discomfort, bloating, abnormally delayed or infrequent bowel movement, or lumpy/hard stool. The symptoms associated with IBS-D include stomach pain and discomfort, an urgent need to move your bowels, abnormally frequent bowel movements, or loose/watery stool.
IBS is the most common gastrointestinal disorder in the U.S., affecting approximately 40 million Americans. It is estimated that at least 5 million Canadians suffer from IBS, with an additional 120,000 people developing the condition every year. IBS affects about twice as many women as men and is most often found in people younger than age 45.
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- Crohn's & Colitis Foundation of America. Inflammatory Bowel Disease and Irritable Bowel Syndrome. Available at: http://www.ccfa.org/assets/pdfs/ibd-and-irritable-bowel.pdf. [Last accessed: October 8, 2015].
- Hulisz, Darrell, RPh, PharmD. "The Burden of Illness of Irritable Bowel Syndrome: Current Challenges and Hope for the Future." Journal of Managed Care Pharmacy 10.4 (July/August 2004): 299-309.
SOURCE Commonwealth Laboratories, LLC