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Second-Generation Blood Test for Irritable Bowel Syndrome (IBS) Validated as Providing Most Conclusive Diagnosis of Inclusion for IBS

May 20, 2019 Off By BusinessWire

SAN DIEGO–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/guthealth?src=hash" target="_blank"gt;#guthealthlt;/agt;–Gemelli Biotech, in partnership with the Medically
Associated Science and Technology (MAST) program at Cedars-Sinai,
announced new findings that validate a second-generation diagnostic
blood test for irritable bowel syndrome (IBS) as the most accurate ever.

Available commercially as ibs-smart™,
the test could provide physicians with the most conclusive data
currently attainable for ruling in IBS. Primarily applicable to patients
with a diarrheal component to their symptoms, the test could serve up to
two-thirds of the 45 million Americans suffering from IBS.

After over a decade of uncovering the pathophysiology of post-infectious
IBS, researchers at Cedars-Sinai validated
the antibodies anti-CdtB and anti-vinculin as highly specific biomarkers
measurable in blood. This innovative blood test offered patients the
first-ever opportunity to receive a diagnosis of IBS by ruling in
the disease, rather than by ruling out other diseases.

Scientists at the Medically Associated Science and Technology program at
Cedars-Sinai, in collaboration with Gemelli Biotech, developed a
proprietary epitope optimization process that was instrumental to
improving the test for its second-generation launch as ibs-smart™.
Cedars-Sinai has entered into an exclusive license agreement with
Gemelli Biotech for several patent applications covering the blood test
technology.

At Digestive Disease Week (DDW 2019) in San Diego, the MAST team
reported the results of their validation study. The second-generation
blood test is >90% specific in distinguishing patients with IBS from
patients with Inflammatory Bowel Disease using each marker. When
combined, the post-test probability of IBS is >98%. That means that for
the first time, a near certain diagnosis of IBS can be made if both
biomarkers are elevated.

Gemelli Biotech is determined to bring ibs-smart™
to physicians worldwide. Physicians in the US can order the test for
patients via a kit-based system. The company helps interested patients
find local specialists and blood draw labs. Samples are tested in a
CLIA-certified lab in Irvine, California. The test is covered at least
in part by most insurance providers.

“It’s painful for millions of IBS patients to keep hearing long lists of
negative test results that tell them what they don’t have,” says Matt
Mitcho, CEO of Gemelli Biotech. “Finally, you can get the most concrete
diagnosis that rules in IBS. We’ve heard
many stories of patients breaking down in tears of relief when doctors
hand them the results of this test.”

Dr. Mark Pimentel, Executive Director of the MAST program, as well as a
practicing gastroenterologist and co-founder of Gemelli Biotech,
believes the greater diagnostic accuracy is meaningful to patients and
doctors alike. “As a physician, I want to know what is causing the
disease in my patient, and I want to know as efficiently as possible.
This test tells me that my patient has IBS and I can get to the desired
therapy without undue testing.”

About ibs-smart™

ibs-smart™ is the second-generation blood test for Irritable Bowel
Syndrome (IBS) and offers an advancement in the specificity and accuracy
of data available to help doctors diagnose Diarrhea Predominant and
Mixed-Type IBS (IBS-D and IBS-M).

About Gemelli Biotech

Gemelli Biotech is a specialty biotechnology company that strives to
achieve a thriving global family of healthy individuals by unlocking the
potential of the microbiome. Gemelli’s mission is to support the
discovery of novel diagnostics and therapeutics for the human microbiome
by bringing biotechnology innovations to market in a fiscally
responsible and socially conscious way.