Respiratory Infections

There are over 60 million cases of acute sinusitis and bacterial pneumonia in the U.S. each year. Health experts estimate that 37 million Americans are affected by sinusitis every year, and Americans spend $5.8 billion each year on health care costs related to sinusitis. In addition, typical infective pneumonia is estimated to affect 1 out of every 100 people annually. Although the majority of the case presentations for these two diseases occur with the primary physician, at least 12 million of these cases present at hospital emergency rooms annually. In fact, these diseases represent over 10% of the emergency department cases, according to the CDC.

Coughs, earaches, congestion, headaches. The respiratory market comprises a wide range of clinical opportunities that MicroPhage believes it can address. This market for bacterial detection can be broken up into several subset markets based on clinical presentation including: upper respiratory tract infections (i.e., bronchitis, pneumonia, laryngitis), sinusitis, otitis media (middle ear infections), and lower respiratory tract infections (e.g., tuberculosis). Here, we briefly address the opportunity for a test for sinusitis and typical infective pneumonia.

The four most prevalent organisms for these clinical presentations include Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus sp. (chiefly S. aureus). S. pneumoniae is the lead causative agent for three of these clinical indications. Because of rising rates of penicillin resistance found in this organism it serves as a good primary target for MicroPhage.

Increasing drug resistance has been regularly reported in all four of these organisms. Differential diagnosis of these organisms and drug susceptibility is perceived as very important in this market segment. A multiplexed assay that covers one or more bacteria and drug susceptibility would be well-received.

There are currently no direct detection diagnostics for these organisms due to the difficulty of differentiating between normal background levels and pathogenic levels. Treatment is predominately prescribed empirically, followed by culture. On average it takes 3 days for results to be reported to the physician.

This test is not cleared by the U.S. FDA nor CE Marked and not yet available for sale.