Regulatory FDA approves MeMed's bacteria-versus-virus blood test to the point...

FDA approves MeMed’s bacteria-versus-virus blood test to the point of care

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MeMed, an infectious disease diagnostic company, has achieved a significant milestone in expanding its market presence in point-of-care settings, thanks to the recent FDA approval of its test that can differentiate between viral and bacterial cases. As a former Fierce 15 winner, MeMed employs machine learning-powered technology to address the issue of antibiotic misuse, preventing the administration of antibiotics when they would be ineffective and potentially lead to drug-resistant infections.

One of MeMed’s groundbreaking products is the BV blood test, which aids healthcare providers in identifying infections in both adults and children, particularly when the site of infection is unknown or difficult to access using traditional diagnostic methods such as swabs. Instead of directly identifying the pathogen causing the infection, the test focuses on profiling the body’s immune response.

In 2021, a previous version of the BV blood test received FDA clearance for use with collected serum. However, the latest 510(k) clearance expands its application to whole blood samples, eliminating the need for time-consuming preparation steps like clotting blood and spinning test tubes. This development allows the BV test and its Key analyzer to be deployed in settings such as urgent care centers, which handle approximately 100 million potential infection cases in the United States annually, as estimated by the company.

MeMed’s CEO, Eran Eden, emphasized that diagnostic uncertainty is one of the main reasons for unnecessary antibiotic prescriptions. Clinicians often struggle to differentiate between bacterial and viral infections since their clinical presentations can be quite similar. By offering a rapid and reliable solution to distinguish between these types of infections, the BV test plays a crucial role in reducing the risk of unnecessary antibiotic prescriptions, which is a major contributing factor to the global issue of antibiotic resistance.

Earlier this year, MeMed forged a partnership with Beckman Coulter to collaboratively develop and commercialize the BV test for the latter’s Access line of immunoassay analyzers. Both companies acknowledge that up to 20% of patients with bacterial infections are underprescribed antibiotics, while the overuse of unnecessary antibiotics poses a significant public health threat worldwide.

In conclusion, MeMed’s FDA-approved BV blood test represents a breakthrough in the field of infectious disease diagnostics. By accurately differentiating between viral and bacterial infections and guiding appropriate antibiotic use, the test can help combat the growing problem of antibiotic resistance, benefitting both patients and the broader healthcare system. With the potential to be implemented in various healthcare settings, MeMed’s innovative technology is poised to make a meaningful impact on improving patient outcomes and global public health.

According to Dr. Sridevi Devaraj, Medical Director of Clinical Chemistry and Point of Care Testing at Texas Children’s Hospital, it’s an amazing breakthrough. Now that the test can be performed directly on whole blood, there will be less handling in the clinical context, as well as a choice between bacterial and viral infections and shorter patient waiting times. This should improve the pleasure of both patients and doctors.

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