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1 año hace
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 años hace
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.
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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 años hace
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.
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