Development of an assay to distinguish viral from bacterial infection

As illustrated by RPS' FebriDx test

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf

Design Control Phases:1. Feasibility2. Optimization3. Analytical/Preclinical (verification)4. Design Transfer5. Clinical (validation)6. Regulatory7. Launch/Marketing/Postmarket

A key driver of this process is overprescription of antibiotics, and we are running out of options:

1. Feasibility: why do it, can we do it?

Antibiotic resistance is a major issue.

http://www.who.int/drugresistance/publications/infographic-antimicrobial-resistance-20140430.pdf

https://www.cdc.gov/drugresistance/about.html

Just search online for antibiotic resistance timeline!

http://www.nature.com/nchembio/journal/v3/n9/fig_tab/nchembio.2007.24_F1.html

The financial burden is considerable = an opportunity exists to generate revenue while saving public and private funds (and lives).

http://www.who.int/drugresistance/documents/AMR_report_Web_slide_set.pdf

Antibiotic stewardship initiatives mean that there might be funding available.

10M for a POC test!

https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf

http://www.safetyandquality.gov.au/our-work/healthcare-associated-infection/antimicrobial-stewardship/

A US national action plan means funding can be sought from NIH, BARDA, DoD, etc.

OK, OK, it's a great idea. Can we do it?

1. RPS focuses on point-of-care testing (lateral flow); good angle vs overprescription

2. RPS has a relationship with Kyowa Medex, who hold patents relating to MxA,which is a biomarker of viral infection (named for association with myxovirus infection, downstream of IL-6 and IFN-//)

This led to a search for additional biomarkers of infection:

C-reactive protein (CRP): widely used as marker of inflammation, agnostic as to cause thereof, not especially well regarded in terms of sensitivity/specificity

Procalcitonin (PCT): also more of an inflammatory marker but somewhat specific for bacterial infection

2. Optimization: from prototype to initial design freeze

Reference ranges:MxA: a cutoff of ~35 ng/ml distinguishes normal (~