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Test Time: Fighting Antibiotic Misuse and Antimicrobial Resistance-Med-Tech Innovation

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Kfir Oved, Chairman, Co-Founder and CTO of MeMed Diagnostics, writes about the development of new technologies aimed at combating antibiotic misuse and antimicrobial resistance (AMR).

The global health challenge of antibiotic misuse and associated antimicrobial resistance (AMR) has been going on for decades. Unfortunately, many new technologies have been introduced to the market in the last few decades, but have not been able to make a significant impact on this major issue. The first step in solving this problem is to ask why cutting-edge technology developed by a good team could not change the incidence and scope of antibiotic misuse and AMR.

The clinical dilemma that doctors face when a patient has a fever seems simple at first glance. Whether to treat with antibiotics? Bacterial and viral infections are often clinically indistinguishable, and the problem arises because doctors often feel compelled to prescribe antibiotics because the cause of the disease is unclear.

Numerous pioneering technologies have been developed over the last few decades, including multiplex PCR, rapid culture systems, rapid testing, and single biomarker analysis, all helping physicians identify pathogens and guide treatment. The purpose is to do.

In order to bring real game changes to antibiotic prescribing habits, every technology must meet a list of requirements such as:

Test accuracy (> 90%) Time to result (minutes) Inaccessible infection site solution Inactive in the presence of natural flora Strong against rapidly evolving pathogens Accessibility at the required time Cost-effective and easy to use

Many of the new technologies have improved in one or more of these aspects, but there is no single technology that checks every box and does not significantly impact antibiotic misuse.

I went back to basics to find a solution.

What’s the problem?

Whether to treat with antibiotics.

What did you look for?

How to distinguish between bacterial and viral infections that meet the above requirements.

How did you do this?

We used a highly sensitive and accurate system that was created naturally, the immune system.

What did we discover?

The immune system responds differently to bacterial and viral infections, but there is no single biomarker that provides this information accurately enough. A large discovery process was used to confirm the relationships between the major groups of biomarkers: TRAIL, IP-10 and CRP, which decode the host’s immune response to the source of infection.

If you look at the list above, this approach will check all the boxes. Multi-parameter signatures that capture the immune response during infection have been shown to be highly accurate in numerous double-blind, multicenter clinical trials (> 90% sensitivity and specificity), and tests using immunoassays have shown. It can be done in minutes and is not necessary. Access the site of infection. The immune system is powerful against the presence of colonies that are part of the natural flora and the detection of emerging pathogens. The MeMed BV test is a combination of our 3 protein signatures and a unique algorithm.

After defining what to measure, I asked how to measure it. This impacts time to results, ease of use, access in the healthcare setting, and cost effectiveness. To this end, we have developed a small immunoassay platform based on magnetic beads and chemiluminescence, and a Me Med Key platform that can perform BV tests in 15 minutes.

Both platforms have been approved with the CE mark, giving doctors the ability to distinguish between bacterial and viral infections and confidently rule out unnecessary prescriptions of antibiotics.

Our aim was to address antibiotic misuse by developing diagnostic solutions that distinguish between bacterial and viral infections with central laboratory accuracy when needed. Data on more than 15,000 patients show that this was done.

The next step in our journey is to use this approach to provide doctors with new, clinically relevant information based on our body’s response to illness and injury.

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