MeMed Diagnostics, an Israeli medical solutions company, has received FDA approval for its diagnostic test and platform, which can distinguish whether an infection is viral or bacterial within 15 minutes
MeMed BV’s blood test has been certified for both children and adults, the company announced on Monday.
Distinguishing between bacterial and viral causes of acute infections is clinically indistinguishable. When there is no supporting evidence helping the doctors, they may mistakenly believe the patient has a bacterial illness when they actually have a viral infection. This leads to giving the patient prescription for antibiotics, which contributes to the formation of antimicrobial resistance (AMR) – one of the top 10 global public health problems of our time.
This occurs as bacteria, viruses, fungi, and parasites develop over time, increasing the difficulty of treating infections. As a result, previously successful medications become ineffective.
The Haifa-based company claims that its technology decodes the body’s immune response to illness, dubbed the “host response,” rather than focusing only on microbe detection.
The blood test produces extremely reliable findings with an Area Under the Curve of 90% to 97% (primary). (AUC, an indication that provides information on the extent of exposure to a drug and its clearance rate from the body – primary and secondary endpoints), MeMed said.
The test “demonstrates solid performance even when the infection site is inaccessible or the cause of infection is developing novel pathogens,” the company said.
Apparent knowledge permits more educated antibiotic treatment decisions, which is critical in the fight against antibiotic-resistant microorganisms.
The FDA granted permission based on the results of a multicenter blinded clinical validation trial involving more than 1,000 children and adults, and it also satisfies the objectives outlined in the United States National Action Plan to Combat Antibiotic Resistance.
MeMed was established a decade ago by Eden and Dr. Kfir Oved, both of whom studied at the Technion, exploring complex behaviors of the immune systems. The two take advantage of the immune response of the patient to differentiate between bacterial and viral diseases.
“It has taken a decade to get from concept to touching patient lives,” said Dr. Eran Eden, co-founder, and CEO of MeMed. “This FDA approval represents a watershed moment in the field of advanced host response and would not have been possible without the commitment of the MeMed team, our clinical partners in the United States and around the world, and the support of the US Department of Defense and the European Commission.”
MeMed has raised some $130 million to date from investors including Horizons Ventures; Chinese holding conglomerate Ping An Group; OurCrowd, and Israeli insurer Clal Insurance.
MeMed has established a US headquarters in Boston and is boosting up commercial activity to ensure that its medications are widely available across the country, the business said.