Lumos FebriDx

Bacterial or non-bacterial infection?

FebriDx aids in the differentiation between bacterial infection and non-bacterial etiology.

Acute respiratory infections, causing symptoms such as common cold, sore throat, cough, congestion and runny nose, are the most common reason for seeking medical advice and antibiotic prescriptions. Differentiating between bacterial infection and non-bacterial etiology can be challenging due to an overlap in signs and symptoms of bacterial and non-bacterial infections.

The majority of acute respiratory infections are caused by viruses and do not require antibiotics, yet antibiotics are prescribed in up to 50% of cases. Antibiotic resistance continues to remain a major global health threat contributing to 2.8 million antibiotic-resistant illnesses and 35,000 deaths each year in the U.S.

FebriDx point-of-care test device

FebriDx is a rapid point-of-care test that uses a fingerstick blood sample to aid in the differentiation between bacterial infection and non-bacterial etiology. FebriDx is intended to be used in urgent and emergency care settings.

Knowing whether a patient has a bacterial infection has a direct impact on reducing unnecessary antibiotic prescriptions, limiting the spread of antibiotic-resistant bacteria, and helping providers know when to initiate treatment.

• Results after 10 minutes increases confidence in whether or not to prescribe an antibiotic.
• Highly sensitive/specific dual biomarker technology provides reliable differentiation of bacterial and non-bacterial infections.
• All-in-one, instrument-free test device means no expensive equipment and a fully portable solution

Acute respiratory infections create challenges.

FebriDx provides solutions.

99% NPV for ruling out bacterial infection

Using FebriDx during a patient visit can reduce diagnostic uncertainty and help guide appropriate patient management and reduce inappropriate antibiotics. Results are available after 10 minutes, allowing the clinician to provide a timely and targeted treatment plan during the initial visit.

• Increase confidence in decision making
  • Confidently rule out a bacterial infection with 99% negative predictive value (NPV)
• Ensure bacterial infections are not overlooked
  • Increased confidence in patient diagnosis
• Improve patient satisfaction
  • Support patient understanding of treatment plan with a tangible test result
• Enable improved patient management
  • Actionable results after 10 minutes for use during a patient visit
• Support antimicrobial stewardship
  • Reduce unnecessary antibiotic use

FebriDx can help reduce unnecessary antibiotics and risks.

Unnecessary use of antibiotics leads to antimicrobial resistance (AMR), causing more than 1.27 MILLION DEATHS globally

Antimicrobial resistant infections cost $BILLIONS in the U.S. each year

Acute respiratory infections and antibiotics

Acute respiratory infections, producing symptoms such as cough, sore throat, runny nose and congestion, are the most common reason patients seek care worldwide.

The majority of acute respiratory infections are caused by viruses and do not require antibiotics, yet antibiotics are prescribed in up to 50% of cases. The overlapping symptoms of acute respiratory infections make it challenging for clinicians to differentiate bacterial from non-bacterial infections.

Implications of unnecessary antibiotic use

There are more than 200 million antibiotic prescriptions written each year in the outpatient setting, approximately 30-50% of which are unnecessary. Unnecessary antibiotic use leads to increased antibiotic resistance and increased costs.

FebriDx can help

FebriDx is intended to be used in urgent and emergency care settings. FebriDx offers rapid, point-of-care results that aid in diagnosing a bacterial infection, which could have a direct impact on the spread of resistant bacteria.

Patient satisfaction

Patients often insist on antibiotics. Since most coughs, colds, sore throats, and runny noses are caused by non-bacterial infections, antibiotics can often be prescribed unnecessarily. FebriDx produces a tangible test result that can be shared with the patient, thereby improving patient satisfaction and confidence in their treatment recommendations.

With a 99% Negative Predictive Value, FebriDx can help rule out bacterial infection and prevent inappropriate antibiotic prescriptions.

FebriDx = 2 Biomarkers

No single biomarker can differentiate bacterial from non-bacterial infection. The FebriDx test utilizes a proprietary combination of two host immune response biomarkers to aid in differentiating bacterial infection from non-bacterial etiology.

CRP (C-Reactive Protein) is a nonspecific, acute-phase protein that is upregulated during the presence of acute inflammation, including response to infection. CRP is predominately produced by the liver in response to inflammatory cytokines such as IL-6 and assists in pathogen recognition and phagocytosis by macrophages. Infection is a potent stimulus of CRP elevation, which occurs within 4-6 hours of infection, doubles every 8 hours and peaks after 36 hours. At low levels CRP is sensitive but non-specific for bacterial infection.

MxA (Myxovirus resistance protein A) is an innate host response biomarker that elevates in the presence of acute viral infection but is not specific to a particular type of virus. MxA has a low basal concentration of less than 15 ng/mL, a fast induction time of 1-2 hours, and a long half-life of 2.3 days. Numerous clinical studies demonstrate that MxA protein expression in peripheral blood has been shown to be a sensitive and specific marker for viral infection. MxA is specific for viral infection only and is not elevated in the presence of a bacterial infection.

Neither MxA nor CRP alone is sensitive or specific enough to differentiate bacterial infection from non-bacterial etiology.4,6,9,10 At a low-level cut off, 20mg/L, CRP is very sensitive but non-specific at confirming bacterial infection. At a high-level cut off; 80-100mg/L, the reverse is true.3,9

By combining the acute phase inflammatory protein, CRP, with a specific viral marker, MxA, FebriDx achieves the sensitivity and specificity to aid in the differentiation of bacterial from non-bacterial acute respiratory infection.

FebriDx multi-center clinical study

Multi-center, prospective, clinical trial demonstrated high sensitivity and specificity of FebriDx in differentiating bacterial from non-bacterial acute respiratory infection.

The study was conducted at 20 point-of-care testing sites. FebriDx was compared to a composite Clinical Reference Algorithm that incorporated pathogen detection testing including bacterial culture and multiplex PCR in addition to measures of host immune response.

FebriDx has a 99% NPV to rule out a bacterial infection.