Commonwealth Diagnostics International, Inc.'s IBSchek® Granted PLA Code from AMA; Company to Now Accept Insurance, Providing More Patients At-Home Access

Maximum out-of-pocket cost for first clinically validated IBS blood test also to be reduced, making it the most affordable IBS diagnostic test on the market

SALEM, Mass., Feb. 3, 2021 /PRNewswire/ -- For too long millions of patients requiring a simple and reliable blood test for Irritable Bowel Syndrome (IBS) have been met with soaring testing costs. Challenging rising healthcare costs, industry leader Commonwealth Diagnostics International, Inc. (CDI) will begin accepting insurance immediately for their proprietary IBSchek® Capillary Collection Kit. Clinically validated in 2015 and revalidated internationally, IBSchek is the most reliable diagnostic blood test for both diarrhea-predominant and mixed-symptom IBS (IBS-D/M) in the market.

CDI will begin billing to all insurance providers for IBSchek immediately, except Medicaid. Additionally, CDI has also announced the maximum out-of-pocket cost for IBSchek will be reduced to $99 for all patients.

With its new market access infrastructure and Proprietary Laboratory Analyses (PLA) Code #0176U, set by the American Medical Association (AMA), as well as its existing inclusion in key diagnostic clinical guidelines including the ROME IV Clinical Decision Toolkit, IBSchek is now the most cost-effective, easily accessible, and clinically-proven IBS blood test available.

"We launched this technology five years ago knowing that we wanted to first introduce and then help democratize testing in the IBS space for healthcare providers and their patients," explained Craig Strasnick, CDI President and CEO. "We knew it was going to be challenging in light of the realities with the US healthcare system and the diagnostic healthcare delivery market, but we are incredibly proud to now be able to offer IBSchek with a PLA Code endorsed by the AMA and at a price point that we know is economically and socially sustainable."

IBSchek is a proprietary blood test for IBS based on the scientific findings of a 2,500+ patient clinical trial that showed that anti-vinculin and anti-CdtB are effective biomarkers for the diagnosis of IBS-D/M. IBS is the most common functional gastrointestinal disease in the U.S., and it is estimated that up to 45 million people, or 10-15% of the American population, suffer from IBS.

IBSchek aligns directly with the American College of Gastroenterology's latest Clinical Guidelines for the Management of IBS that suggest a "positive diagnostic strategy as opposed to a diagnostic strategy of exclusion be used to improve time to initiating appropriate therapy."

Continued Strasnick, "IBSchek significantly assists healthcare providers in quickly and accurately diagnosing IBS-D/M. Patients are granted direct access, simple and safe at-home sample collection, free shipping and easy-to-understand results in only a few days' time."

The new $99 out-of-pocket maximum for IBSchek is extremely significant. When CDI launched IBSchek in 2015, peer-reviewed health economics data showed the approximate cost of a diagnostic blood test of this nature at upwards of $500. In order to offer the technology at a fair price to the public in 2021 and beyond, CDI has dedicated tremendous time and effort to improve the science and delivery of IBSchek.

"With great thanks to our clinical and operational teams, and our trusted clinical advisors, we look forward to offering this technology and the detection of these important antibodies to the industry at a patient-centric price far below any other lab in the country," concluded Strasnick.

There is no account setup required for healthcare providers to start ordering IBSchek for their patients. IBSchek is available in the US as well as the UK and across Europe via Conformitè Europëenne (CE) marked kits. For more information about IBSchek® please visit commdx.com/ibschek.

About Commonwealth Diagnostics International, Inc:
Commonwealth Diagnostics International, Inc. (CDI) is an innovative GI health company providing industry-leading diagnostic tests and tools to help physicians identify and diagnose common sources of digestive distress and functional gastrointestinal ailments. Focused on our patient-centric principles, our cost-effective portfolio of diagnostic products results in expedited treatment, better patient outcomes, and robust cost savings for the healthcare delivery system. Our expansive portfolio includes non-invasive at-home breath testing kits for Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methane Overgrowth (IMO), and carbohydrate malabsorption disorders, as well as IBSchek®, a proprietary capillary collection test for Irritable Bowel Syndrome (IBS-D/M), and MyGIHealth, a cloud-based platform that enables patients to monitor, manage and understand their GI-related symptoms. Operating out of our CLIA-certified laboratory, and as an FDA registered, ISO 13485 certified medical device manufacturer, we pride ourselves on our partnerships with industry-leading health systems, hospitals, and private practices worldwide. For more information, visit commdx.com.

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SOURCE Commonwealth Diagnostics International, Inc.

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