subslover
11月前
Over 80% of gastric cancers are attributed to H. pylori bacterial infection
Gastric cancer is the third most common cause of cancer related death in the world
H. pylori infection is also a major cause of peptic ulcers
IRVINE, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic products, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Hp Detect™ Stool Antigen ELISA test (K232892), a new product that is designed to detect the presence of the H. pylori bacteria, which infects approximately 35% of the U.S. population. H. pylori infection is a disease which affects half the population of the world.
The Biomerica Hp Detect™ test detects the presence of the H. pylori bacteria which infects approximately 35% of the U.S. population. Over 80% of gastric cancers are attributed to H. pylori infection, and gastric cancer is the third most common cause of cancer-related death worldwide. Physicians and medical centers will be able use the results from the Hp Detect™ Stool Antigen test to diagnose the presence of H. pylori and assess H. pylori infection status after treatment.
Dr. William Chey, an expert in the management of H. pylori infection and Chief, Division of GI and Hepatology, Michigan Medicine, stated, “Testing for H. pylori eradication to assess status after treatment is crucial, especially in the context of increasing antibiotic resistance.”?
Biomerica’s Chief Executive Officer Zack Irani stated, “This FDA clearance is a milestone in our commitment to bringing a diagnostic solution for over 115 million people suffering from H. pylori infection across the U.S. We are particularly excited about this product as it has been shown to be highly accurate and has several key advantages for laboratories, physicians and patients. We have also created an efficient, low-cost manufacturing process that should enable high gross margins on this product.”
subslover
2年前
Biomerica’s Aware® Breast Self Exam and EZ Detect™ Colon Disease Test Now Available on Amazon and Fulfilled by Amazon
September 29, 2022 08:19 ET | Source: Biomerica, Inc.
...
Aware® is a simple at-home device to increase sensitivity in breast self-exams. About 80% of breast cancer is detected by women themselves who notice changes in their breast.
EZ Detect™ is a simple 2-minute, at-home test which detects an early warning sign of colorectal cancer
IRVINE, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) today announced that the Company’s Aware® Breast Self Exam device and EZ Detect Colon Disease test are now being sold on Amazon and fulfilled by Amazon.
Aware: https://www.amazon.com/gp/product/B010OVMR2S/ref=ewc_pr_img_1?smid=A12JU5SP5PIFD3&psc=1
EZ Detect: https://www.amazon.com/gp/product/B00EF2BPZ8/ref=ewc_pr_img_1?smid=A12JU5SP5PIFD3&psc=1
The Biomerica FDA-cleared Aware® Breast Self Exam device is a revolutionary way for women to enhance tactile sensitivity to changes or irregularities in breast tissue, making breast self-exams easy and convenient. The Aware® device can facilitate an effective self-exam and can serve as a reminder to perform a breast self-exam every month.
Breast Cancer is the most common cancer among women. Unfortunately, every woman is potentially at risk, as more than 70% of women diagnosed have no family history of breast cancer. Early detection significantly improves the chances that breast cancer can be diagnosed and treated successfully. Survival rates are as high as 99% when the cancer is found early while still localized in the breast. However, if the cancer has spread to the regional lymph nodes, the 5-year survival rate falls to 86%[1,2]. About 80% of breast cancer cases are detected because women themselves notice changes in their breast[3]. This highlights the important role that each woman can play in managing their own health. However, a breast self-examination is not a replacement for regular medical visits and periodic ultrasound or mammography. All three steps are important to finding breast cancer early. The relevance of early detection cannot be overemphasized.
The Biomerica EZ Detect™ Colon Disease Test is the simplest in-home, two-minute diagnostic test to detect hidden blood in the stool, one of the primary early warning signs of colorectal disease. The test does not require handling of stool or dietary restrictions.
Colorectal cancer (“CRC”) is the second most common cause of cancer death in the United States. In 2020, an estimated 147,950 individuals would be diagnosed with CRC and an estimated 53,200 would die from the disease, including 17,930 cases and 3,640 deaths in individuals under the age of 50[4].
In a study performed by Johns Hopkins University, EZ Detect™ was preferred 10:1 by patients over another fecal occult blood test. Published studies have also indicated that the best colorectal screening test is “the one that gets done.”[5] With EZ Detect, the user simply drops a test pad onto the surface of the water in the toilet bowl after a bowel movement. If blood is present in the person’s stool, a blue-green indicator will appear on the test pad within two minutes. The pad is then simply flushed down the toilet. Other colorectal screening tests require collecting a stool sample and mailing it to a lab for processing. Requiring a patient to collect and mail a stool sample results in a high percentage of these competing tests never being performed by patients[6]. EZ Detect is simple to perform and provides results in just two minutes.
Zack Irani, Chief Executive Officer of Biomerica, commented, “The key to better outcomes in all cancers is early detection and regular screening. Both Aware and EZ Detect are inexpensive and easy to use. Both can be performed in the privacy of one’s home. I’m proud of the work we do to produce products that help save lives and improve the health of people.”
For further information about the Aware® Breast Self Exam Product and the EZ Detect Colon Disease test, please visit https://AwareBSE.com and https://ezdetect.com
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.
1. https://www.webmd.com/breast-cancer/guide/breast-cancer-survival-rates. Accessed 08 July 2022
2. https://www.cancer.net/cancer-types/breast-cancer/statistics. Accessed 08 July 2022
3. https://www.pinkribbon-deutschland.de/vorsorge-fakten/fakten, accessed 02 AUG 2022
4. Siegel, R.L., et al., Colorectal cancer statistics, 2020. CA Cancer J Clin, 2020. 70(3): p. 145-164.
5. Lansdorp-Vogelaar, I., A.B. Knudsen, and H. Brenner, Cost-effectiveness of colorectal cancer screening - an overview. Best Pract Res Clin Gastroenterol, 2010. 24(4): p. 439-49.
6. Navarro, M., et al., Colorectal cancer population screening programs worldwide in 2016: An update. World J Gastroenterol, 2017. 23(20): p. 3632-3642.
crudeoil24
3年前
Biomerica Reports Walmart Is Now Selling Its EZ Detect Colorectal Screening Test
6:39 am ET October 1, 2021 (Benzinga) Print
Simple 2 minute at-home test detects early warning sign of colorectal cancer
IRVINE, Calif., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ:BMRA) (the “Company”) today announced that it has entered into a General Merchandise Supplier Agreement with Walmart for the sale of the Company’s EZ Detect™ colorectal disease screening test within the Walmart retail system. The Company has now shipped its first orders of the EZ Detect™ product to Walmart, and beginning this week, Walmart has begun selling the product through its online sales channel (https://www.walmart.com/ip/EZ-Detect-Colon-Disease-Test-Kit/577079744).
Biomerica is also in the final phase of working with Walmart to stock and sell the EZ Detect product on the shelf in their stores. In addition, the Company is in negotiations with several large partners for distribution of the EZ Detect™ product in Asia, Europe and the Middle East.
The EZ Detect™ colon disease screening test is the simplest at-home test to detect occult (hidden) blood in a person’s stool, which can be an early warning sign of colorectal diseases, including colon and rectal cancers. The test does not require handling of stool or dietary restrictions. A person simply places an EZ Detect™ test pad into the toilet after a bowel movement. A change in the pad’s color to blue/green, which would appear within two minutes, indicates the presence of blood in the stool. The pad is then simply flushed down the toilet.
Colorectal cancer (“CRC”) is the second most common cause of cancer death in the United States. In 2020, an estimated 147,950 individuals would be diagnosed with CRC and an estimated 53,200 would die from the disease, including 17,930 cases and 3,640 deaths in individuals under the age of 50 [1].
In a study performed by Johns Hopkins University, EZ Detect™ was preferred 10:1 by patients over another fecal occult blood test. Published studies have also indicated that the best colorectal screening test is “the one that gets done.” [2] Other colorectal screening tests require handling of the stool and delivering or mailing the stool sample to a lab for processing. Handling of the stool results in a high percentage of these competing tests never being performed by patients[3]. EZ Detect™ does not require handling of the stool, is simple to perform and provides results in just two minutes.
“With the current COVID-19 pandemic, consumers have become much more aware of at-home diagnostic testing and are more comfortable performing these tests. For this reason, many global retailers are expanding their focus on selling home health solutions. This growing trend presents many opportunities for our EZ Detect™ colorectal disease test, our Aware™ breast self-exam product and other products that we make for in-home use. While there are other choices for colorectal disease screening, EZ Detect™ offers the only alternative that doesn’t require handling of the stool, making our test more appealing and easier to conduct from the consumer perspective. In addition, the agreement for online sales of EZ Detect with Walmart could bring significant exposure to the product here in the US,” commented Zack Irani, CEO of Biomerica.
For further information about the EZ Detect Product, please visit ezdetect.com.
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
DegenerateGambler
4年前
Biomerica Inc. (NASDAQ: BMRA) announced today they have submitted to the FDA an EUA application for an ELISA lab-based serology blood test for the detection of antibodies that identify if a person has been infected with the novel coronavirus (COVID-19). Antibody testing can be an important next step in opening the economy to tell people if they have been previously infected. This is the third COVID-19 antibody test introduced by the Company. The other two, which are finger-prick rapid tests, are actively being sold outside of the US and have been well received. The Company also intends to obtain a CE mark to market and sell this ELISA laboratory test outside the US.
Biomerica performed testing both internally and at two external labs located in California. The data from this testing that was submitted to the FDA under the EUA application showed 100 percent specificity and zero percent cross reactivity with many common disease states. This test, which uses the ELISA microplate format, can be run on existing open system equipment found in most hospitals and clinical laboratories in the US and outside the US and uses a modified, trimeric spike protein from the SARS-CoV-2 virus. This spike protein is known to be the target of neutralizing antibodies, which can help prevent the virus from entering the cells.1 Persons who are no longer infectious and have tested positive for the antibodies, can possibly be cleared to return to work as they may have a lower likelihood of reinfection and/or spreading the virus. Antibody tests will also help in better understanding the virus including how long antibodies stay in the body and if they help in immunity as well as how many people have been infected in the population as a whole. Further, this type of testing could be particularly important for the immune surveillance of health care workers, first responders, government workers, and others whose infection risks could be heightened by working with COVID-19 infected individuals.
This ELISA laboratory test was developed by Biomerica and will be manufactured exclusively at Biomerica’s manufacturing facility located in Irvine, California, using existing high-throughput, automated equipment. Biomerica has extensive experience manufacturing similar serology ELISA tests for other diseases.
"We are working to provide significant, high specificity and meaningful diagnostic solutions for the novel Coronavirus," said Zack Irani-Cohen, CEO and Chairmen of Biomerica. "Our ELISA test will be unique in the market place by simplifying the blood sample collection process in a proprietary way. We have been working with the FDA, who has been very responsive, and we’re looking forward to a quick review for this submission. I’m very proud of our team members who are working around the clock to develop, validate and attain regulatory clearance on these covid-19 diagnostic solutions that benefit patients, healthcare workers and society”.
About Serology Tests
Serology tests look for the presence of antibodies, which are specific proteins made in response to infections. The antibodies detected by serology tests indicate that a person has had an immune response to the novel Corona Virus (SARS CoV-2), whether symptoms developed from infection or the infection was asymptomatic. Antibody test results are important in detecting infections with few or no symptoms.2
1. medRxiv preprint doi: https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun20
2. Emerging Microbes & Infections 2020, VOL. 9 Molecular and serological investigation of 2019-nCoV infected patients.
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 primarily focus is on Gastrointestinal and inflammatory Diseases where the Company has multiple diagnostic and therapeutic products in development.
About InFoods®
The Biomerica InFoods® IBS product is designed to allow physicians to identify patient specific foods (e.g. eggs, broccoli, wheat, potatoes, corn, etc.), that when removed from the diet, may alleviate or improve an individual's IBS symptoms including, but not limited to, constipation, diarrhea, bloating, pain and indigestion. This patented, diagnostic-guided therapy is designed to allow for a patient specific, guided dietary regimen to improve Irritable Bowel Syndrome (IBS) outcomes. The point-of-care product is being developed to allow physicians to perform the test in-office using a finger stick blood sample while a clinical lab version of the product will be the first for which the company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians' offices is already available for InFoods® diagnostic products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects. An estimated 45 million people in America currently suffer from IBS making it a leading cause for patient doctor visits.
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 efficacy of the Company’s COVID-19 test, FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, pricing of the Company’s test kits, demand for international orders, availability of the Company’s COVID-19 test kits, and patent protection on the test technology. 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 COVID-19 test; regulatory approvals necessary prior to commercialization of the Company’s COVID-19 test; availability of the Company’s COVID-19 test kits; 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 COVID-19 test; 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; regulations and the Company’s ability to obtain patent protection on any aspects of its rapid test technology. 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.
CONTACT INFORMATION
Company Spokesperson
949-645-2111
www.biomerica.com
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