A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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Biomerica’s IBS test now validated for finger stick blood usage

Biomerica, a leading global provider of medical diagnostic products, has announced that its InFoods® Irritable Bowel Syndrome (IBS) test is now validated for finger stick blood usage. This is a significant development for patients suffering from IBS, as it allows for a more convenient and less invasive testing process.

IBS is a common gastrointestinal disorder that affects millions of people worldwide. It is characterized by symptoms such as abdominal pain, bloating, constipation, and diarrhea. The exact cause of IBS is unknown, but it is believed to be related to a combination of factors, including genetics, diet, stress, and gut microbiome imbalances.

The InFoods® IBS test is a patented diagnostic tool that uses a proprietary algorithm to identify specific food-related triggers that may be causing IBS symptoms. The test involves analyzing a patient’s blood sample for the presence of antibodies to certain food antigens. By identifying these triggers, patients can make dietary changes that may help alleviate their symptoms.

Traditionally, the InFoods® IBS test required a venous blood draw, which can be uncomfortable and inconvenient for patients. However, with the validation of finger stick blood usage, patients can now provide a small sample of blood from their fingertip, which is less invasive and more convenient.

According to Zackary Irani, CEO of Biomerica, “We are excited to offer this new option for patients who suffer from IBS. The ability to use finger stick blood samples makes the InFoods® IBS test more accessible and easier to administer, which we believe will lead to increased patient compliance and better outcomes.”

The validation of finger stick blood usage for the InFoods® IBS test is the result of a clinical study conducted by Biomerica. The study compared the results of venous blood draws and finger stick blood samples from 30 patients with IBS. The study found that the results from the finger stick blood samples were comparable to those from the venous blood draws, indicating that finger stick blood usage is a valid and reliable option for the InFoods® IBS test.

In conclusion, the validation of finger stick blood usage for Biomerica’s InFoods® IBS test is a significant development for patients suffering from IBS. It offers a more convenient and less invasive testing process, which may lead to increased patient compliance and better outcomes. As more healthcare providers adopt this new option, it is expected to become the standard of care for IBS testing.

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