ID Genomics’ CLoNeT E. coli Assay in Development to Combat Antibiotic Resistant Urinary Tract Infections

ID Genomics, SPC today announced the completion of its first Pre-Submission meeting with the Food and Drug Administration for the CLoNeT E. coli Assay for Urinary Tract Infections (UTIs).

“We continue to make great strides in our development plans for the CLoNeT E. coli Assay,” said Linda Zuckerman, Ph.D., President and CEO. “This unique product will be able to detect the presence of E. coli, “fingerprint” or identify the clonal family that is present and provide a map of antibiotic resistance. Our ultimate goal is to help empower physicians to make the best choice of antibiotic for UTIs, as well as other infections, before the patient leaves the office.”

In the United States, UTIs result in an approximately eight million physician visits and over 100,000 hospitalizations with an associated annual cost of $1.6 billion. Half of all women experience at least one UTI by the age of 35 and roughly 20% of women between the ages of 18 and 24 have a UTI annually (Simmering et al, 2017). A recent study from 2018 by Thorpe et al., found that antibiotic resistance added about $1,300 to the cost of treating a patient with a bacterial infection resulting in costs to payers of up to $2.2B annually.

This is an impactful issue for millions of American women. There is growing evidence that these infections are increasingly resistant to antibiotics which has turned routine diagnosis and treatment into one that is leading to more hospitalizations, graver illnesses and prolonged discomfort.