inFoods® IBS Test Now Validated for Use with Simple Finger Stick Whole Blood Collection Technology
2023年5月18日 - 9:19PM
Biomerica Inc. (NASDAQ: BMRA), a global biomedical company leading
the way in innovative gastroenterology solutions, announced a
significant advance in the management of irritable bowel syndrome
(IBS). The inFoods® IBS diagnostic test has now been validated for
use with finger stick (capillary) patient whole blood samples
simplifying sample collection and facilitating wider access to the
test. With this new finger stick blood collection option, any
trained medical professional in the doctor’s office can collect the
patient’s blood sample during their office visit and forward the
sample to the Lab for processing. This workflow enhancement greatly
simplifies the process for healthcare providers to order the
inFoods IBS test and is much easier for patients. The InFoods
IBS test will continue to be available using blood collected from a
patient’s arm (venipuncture) by a trained phlebotomist.
The inFoods® IBS test is the first of its kind to identify
specific foods that may trigger or provoke an IBS symptom,
providing personalized dietary recommendations to help manage this
often-debilitating condition. The test is offered as a laboratory
developed test (LDT) performed in a CAP accredited, CLIA-certified
high-complexity laboratory.
It is estimated that over 40 million Americans suffer from IBS,
with symptoms often triggered by consumption of specific foods
(which are unique to each patient). The total direct and indirect
cost of IBS has been estimated at $30 billion annually in the
United States alone.
"This is a significant step forward for patients, healthcare
providers, and the broader medical community," said Zackary Irani,
CEO of Biomerica. "By enabling the use of finger stick whole blood
samples, we're making our personalized IBS therapy more convenient
and easier than ever. This process reduces patient discomfort, and
facilitates wider access to the inFoods IBS test, allowing
healthcare providers in a variety of settings to efficiently use
inFoods IBS and initiate appropriate treatment plans."
Mr. Robert Carlson, Biomerica’s Chief Commercial Officer stated,
"This advancement reflects our continued commitment to innovation
and significantly expands the number of physician offices that can
use the inFoods IBS system to create treatment protocols for their
IBS patients". "Our goal is to make living with IBS easier by
providing a personalized and accessible test that empowers patients
to understand potential food triggers and help control their
condition."
The inFoods IBS clinical study was performed at several
prominent centers including Mayo Clinic, Beth Israel Deaconess
Medical Center Inc. - a Harvard Medical School Teaching Hospital,
Houston Methodist Hospital, and the University of Michigan. In data
presented May 8th at the 2023 Digestive Disease Week (DDW) annual
meeting, clinical results for improvement in the Abdominal Pain
Intensity (API) responder endpoint of >30%, for IBS patients in
the treatment diet arm had a statistically significant improvement
over patients in the placebo diet arm (p-value of 0.0246). The
improvement for patients in the treatment arm versus the placebo
arm is considered clinically significant and is similar and, in
some cases, better than the current drugs in the market.
About InFoods IBS: The InFoods IBS test involves a simple blood
collection procedure and is designed to assess a patient’s above
normal immunoreactivity to specific foods. Instead of difficult to
manage broad dietary restrictions, physicians can now use the
InFoods IBS information to make targeted, patient-specific
recommendations about specific foods that, when removed from the
diet, may alleviate IBS symptoms such as pain, bloating, diarrhea
and constipation. Further information about Biomerica’s patented
InFoods® Technology Platform can be found at:
https://biomerica.com/inFoods/our-technology/About
Biomerica (NASDAQ: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical
technology company that develops, patents, manufactures and markets
advanced diagnostic and therapeutic products used at the point of
care (in home and in physicians’ offices) and in hospital/clinical
laboratories for detection and/or treatment of medical conditions
and diseases. The Company’s products are designed to enhance the
health and well-being of people, while reducing total healthcare
costs. Biomerica’s primarily focus is on gastrointestinal and
inflammatory diseases where the Company has multiple diagnostic and
therapeutic products in development.
The Private Securities Litigation Reform Act of 1995 provides a
"safe harbor" for forward-looking statements. Certain information
included in this press release (as well as information included in
oral statements or other written statements made or to be made by
Biomerica) contains statements that are forward-looking, such as
statements relating to the Company’s InFoods® IBS test and other
tests, FDA clearance or possible future clearance of the Company’s
InFoods® IBS test and other products, timing of the commercial
launch of the InFoods® IBS test, the efficacy of the InFoods
product, possible future revenues from the sale of the InFoods® IBS
test, growth in future revenues from the sale of the InFoods® IBS
test, acceptance of the InFoods® IBS test by physicians and their
patients, international regulatory approval and sales of the
InFoods® IBS test, accuracy, efficacy and clinical trial results of
the InFoods® IBS test, the rapidity of testing results,
negotiations with clinical labs who would offer the InFoods® IBS
test, the ability of a CLIA-certified, high-complexity lab to offer
the InFoods® IBS test as a laboratory developed test (LDT),
discussions with physicians and physician groups who could or would
offer the InFoods Test to their patients, efficacy of the InFoods
IBS test to improve IBS symptoms in patients, the company’s ability
to manufacture the InFoods® IBS test as a commercial product and to
increase manufacturing capacity to meet future product demands, any
future FDA marketing authorization, the uniqueness of the Company’s
InFoods® IBS test and other products, pricing of the Company’s
InFoods® IBS test, future possible insurer reimbursement for the
InFoods® IBS test, patent protection on the InFoods® IBS and the
underlying technology of the test, or on any of the Company’s other
products or technologies, and current or future competition for the
InFoods® IBS test from other medical manufacturers or distributors.
Such forward-looking information involves important risks and
uncertainties that could significantly affect anticipated results
in the future, including, without limitation: results of studies
testing the efficacy of the Company’s tests and products;
regulatory approvals necessary prior to commercialization any of
the Company’s products; availability of the Company’s test kits and
other products; capacity, resource and other constraints on our
suppliers; dependence on our third party manufacturers; dependence
on international shipping carriers; governmental import/export
regulations; demand for our various tests and other products;
competition from other similar products and from competitors that
have significantly more financial and other resources available to
them; governmental virus control regulations that make it difficult
or impossible for the company to maintain current operations; the
Company’s ability to comply with current and future regulations in
the countries where our products are made and sold and the
Company’s ability to obtain patent protection on any aspects of its
rapid test technologies. Accordingly, such results may differ
materially from those expressed in any forward-looking statements
made by or on behalf of Biomerica. Additionally, potential risks
and uncertainties include, among others, fluctuations in the
Company's operating results due to its business model and expansion
plans, downturns in international and or national economies, the
Company's ability to raise additional capital, the competitive
environment in which the Company will be competing, and the
Company's dependence on strategic relationships. The Company is
under no obligation to update any forward-looking statements after
the date of this release.
Corporate Contact:
Zack Irani-Cohen949-645-2111 investors@biomerica.com
Source: Biomerica, Inc.
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