Clearance for these sample types will double the accessible market for KeyPath™ to more than 90% of U.S. hospitals.
On May 6, 2011, MicroPhage received initial 510(k) clearance from the U.S. Food and Drug Administration to market its KeyPath™ MRSA/MSSA Blood Culture Test, which returns same-day antibiotic susceptibility results from positive blood cultures for deadly S. aureus infections. Upon issuance of the clearance, the FDA stated that the KeyPath Test, "...not only saves time in diagnosing potentially life-threatening infections but also allows health care professionals to optimize treatment...". To date, no other tests have gained FDA clearance to report accelerated antibiotic susceptibility results.
Leading hospitals and medical centers are beginning to offer this test. The University of Texas Medical Branch (UTMB) in Galveston, Texas, will offer the KeyPath™ Test beginning this month. Says Michael Loeffelholz, Ph.D., Director, Clinical Microbiology Laboratory, "Never have we implemented a test so 'painless' to the laboratory, yet with the potential for such huge impact on patient care."
Currently, nearly half of patients with Staphylococcus aureus bloodstream infections receive suboptimal antimicrobial therapy1, and thus are exposed to an increased risk of death. KeyPath™ provides physicians with a tool for selecting safer and more effective therapy much sooner than is practiced today. While appropriate therapy is critical for all patients with Staphylococcus aureus bloodstream infections, optimizing therapy for those with Methicillin Sensitive Staphylococcus aureus (MSSA) infections was documented to reduce mortality hazards by 69% according to a study conducted by Marin L. Schweizer of the University of Maryland School of Medicine2. "Patients who died had a longer time to receipt of nafcillin or cefazolin (mean = 4.0 days) compared to those who survived (mean = 2.5 days)." KeyPath™ can provide both MSSA and MRSA (Methicillin Resistant Staphylococcus aureus) test results within one day, well within the 2.5 day window highlighted in this study. By comparison, the majority of U.S. hospitals report such results after 3 days.
While many physicians and hospitals are interested in adopting the test, numerous challenges exist. Many rely on significant levels of outcomes evidence to change medical practice, evidence that is typically in short supply for new technologies. "It takes innovators such as UTMB to challenge existing thinking and adopt new and innovative products that have the potential to save lives," said Richard Proctor MD, Professor Emeritus at the University of Wisconsin Medical School and a chief advisor to MicroPhage. "As KeyPath™ continues to gain customer acceptance, the Company intends to commission studies that yield the evidence needed by other hospitals and physicians to adopt the test."