New Study Demonstrates Potential Cost Savings Associated with Use of IBSchek™ Diagnostic Blood Panel for Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

SALEM, Mass., June 8, 2016 /PRNewswire/ -- Commonwealth Laboratories, LLC (Commonwealth) announced today the publication of a health economic analysis that predicts the potential cost savings associated with the use of the novel IBS diagnostic blood panel IBSchek™.

The study, published as an Article in Press in Clinical Therapeutics, utilized a cost-minimization (CM) decision tree model, a budget impact analysis, as well as physician surveys to compare the economic values.

The study results demonstrate that using the IBSchek diagnostic blood panel may result in both greater efficiencies in diagnosing IBS as well as cost savings to the healthcare system. A budget impact analysis estimates that, when the cost savings are amortized over one million lives, IBSchek will save healthcare payers more than $3.5 million annually. 

A cost-minimization decision tree model predicts an estimated $509 cost savings with use of IBSchek versus the exclusionary diagnostic pathway, which is the current standard of care. Additionally, the exclusionary diagnostic pathway was estimated conservatively in this study. It did not consider repeated investigations (i.e., multiple colonoscopies), the potential for more invasive studies stemming from false-positive results of the investigations, or the cost of pathology assessments.

"The financial and emotional toll of diagnosing IBS is substantial –diagnosis takes an average of 6.6 years, and patients typically consult with more than four healthcare providers about their symptoms¹, which adds up to many physician visits, tests and suffering," said Mark Pimentel, MD, Investigator and Director of the Gastrointestinal Motility Program and the Director of the Pimentel Laboratory at Cedars-Sinai. "IBSchek can help diagnose IBS patients earlier so physical symptoms may be treated, resulting in a reduction of the financial burden of IBS on both patients and the healthcare system."

Traditionally, a diagnosis of IBS was made only after excluding other gastrointestinal conditions, such as Crohn's disease and ulcerative colitis. This exclusionary process takes time and often requires patients to undergo costly and invasive medical procedures, such as colonoscopies, computed tomography (CT) scans, and endoscopies, among others. These invasive diagnostic procedures may have risks for patients, who can experience complications such as bacterial infection, hemorrhage and bowel perforation.

"We are excited that a diagnosis with IBSchek has the potential to provide significant cost-savings and allow patients to proceed with the right course of treatment more quickly," said Craig Strasnick, Chief Operating Officer at Commonwealth. "Commonwealth remains dedicated to helping patients suffering from IBS, which is often debilitating and associated with high medical costs."

IBSchek is a simple blood test designed to help physicians diagnose IBS, the most common gastrointestinal disorder in the U.S., which affects approximately 40 million Americans². IBSchek identifies the presence of two antibodies in a blood specimen – anti-CdtB and anti-vinculin. Elevated levels of either of these antibodies can confirm a diagnosis of diarrhea-predominant IBS (IBS-D) or IBS-Mixed (IBS-M).

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 24 hours after the patient's blood specimen is received by Commonwealth for analysis. More information on IBSchek can be found at www.IBSchek.com.

About the Study
A Predictive Model to Estimate Cost Savings of a Novel Diagnostic Blood Panel for Diagnosis of Diarrhea-predominant Irritable Bowel Syndrome was published online on May 31, 2016 in Clinical Therapeutics as an Article in Press and will be published in print in a future issue of Clinical Therapeutics.

Several methods were utilized to estimate the potential cost savings of using the IBSchek diagnostic blood panel that tests for the presence of anti-CdtB and anti-vinculin associated with IBS-D.

• A Cost-minimization Decision Tree Model for gastroenterology practices in the United States was constructed to compare two differing diagnostic strategies. This model predicts that use of the novel IBS diagnostic blood panel may result in an estimated cost savings of $509 [per patient], by allowing patients to proceed to treatment earlier, thereby avoiding unnecessary testing. It is important to note that the cost savings are dependent on the probability a test result would lead to treatment.
• A Budget Impact Analysis was performed for a hypothetical health plan with one million covered lives. The prevalence of IBS was estimated from medical literature with analysis performed for the U.S. population aged 18-64. Analysis computes the difference in net costs for two scenarios: 1) 100 percent of eligible patients are diagnosed with the exclusionary pathways; 2) 50 percent of eligible patients are diagnosed with the IBS diagnostic blood panel pathway.
• Two Surveys were developed and completed by nine expert gastroenterologists from primarily academic centers in the United States. The first survey looked at physician and patient characteristics (e.g., insurance type, patient distribution by subtype, time to diagnosis, etc.). The second survey addressed the same variables in the first survey, but in a more detailed manner.

Researchers disclosed several limitations when interpreting the study data, including wide range of response in the surveys and survey sample size, potential for physicians to initiate treatment before conducting testing, and that the decision to send a patient for treatment is affected by individual biomarker outcomes.  

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 utilizes a service-based approach to diagnostics that focuses on accessibility and simplicity. Commonwealth's scalable, efficient and clinically sophisticated platform provides the data and 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].

About IBSchek™
IBSchek™ is based on the scientific findings of Mark Pimentel, M.D., and his research team at Cedars-Sinai Medical Center, which confirmed that anti-vinculin and anti-CdtB are effective biomarkers for the diagnosis of IBS-D. An additional study, "Assessment of anti-vinculin and anti-CdtB antibodies in IBS subtypes" (Rezaie A., Gastroenterology, April 2016, vol. 150; issue 4; supplement 1, pg. S62), later validated the efficacy of the test in diagnosing IBS-M as well. The test utilizes a proprietary, ELISA-based blood test, providing results within 24 hours of sample receipt at Commonwealth. The test's turnkey approach is office-friendly and supplies healthcare providers with the objective data they need to make an informed diagnosis, while also providing validation for the symptoms and associated discomfort that IBS patients often experience for extensive periods of time. 

About IBS
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 Americans². It is estimated that at least 5 million Canadians suffer from IBS, with an additional 120,000 people developing the condition every year³. IBS affects about twice as many women as men and is most often found in people younger than age 45⁴.

Contact Information
Erinn White
Centron PR
[email protected]
646-722-8822

¹ International Foundation for Functional Gastrointestinal Disorders. Reporter's Guide to Irritable Bowel Syndrome- Second Edition. Published December 2015. Available at: http://www.iffgd.org/images/pdfs/ReportersGuideIBS.pdf. [Last accessed: June 2, 2016]

² 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: April 11, 2016].

³ Canadian Digestive Health Foundation. Understanding Irritable Bowel Syndrome (IBS). Available at:  http://www.cdhf.ca/bank/document_en/15understanding-irritable-bowel-syndrome-ibs-cdhf-guide.pdf. [Last accessed: May 17, 2016].

⁴ National Institute of Diabetes and Digestive and Kidney Diseases. Definition and Facts for Irritable Bowel Syndrome. Available at: http://www.niddk.nih.gov/health-information/health-topics/digestive-diseases/irritable-bowel-syndrome/Pages/definition-facts.aspx. [Last accessed: May 17, 2016].

SOURCE Commonwealth Laboratories, LLC

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