SEATTLE (19 July 2019) – 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.
About ID Genomics, SPC
ID Genomics, SPC is a leading biotech start up focused on development of cutting edge molecular diagnostics to detect and map antibiotic resistance. In addition to the CLoNeT E. coli Assay for UTI, the company is developing diagnostic tools for Staphylococcus aureus, Klebsiella pneumoniae, and other pathogenic bacteria. The company has a BactNet database of over 31,000 bacterial strains, including 10,000+ which have been “fingerprinted” into clonal families of antibiotic resistance.
Safe Harbor Disclosure
This news release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties and are based on the current expectations, views, and beliefs of ID Genomics, SPC as of the date of this release and should not be relied upon as reflecting the company’s expectations, views, and beliefs at any date subsequent to the date of this release. ID Genomics, SPC disclaims any intention or obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.