The National Institute of Allergy and Infectious Diseases (NIAID) is interested in supporting the advanced development of promising integrated clinical sample-to-answer multiplex diagnostic platforms for emerging and re-emerging infectious diseases.
Under the newly issued Broad Agency Announcement (BAA), NIAID is seeking responses from organizations developing multiplex platforms which may be a single operating unit capable of accepting a clinical sample, or be composed of a cartridge and cartridge-operating unit.
The objective of the initiative is to advance the development of an integrated clinical sample-to-answer multiplex diagnostic platform up to and/or through the Food and Drug Administration (FDA) clearance process. Responses to the BAA must specifically address current diagnostic testing capabilities for Bacillus anthracis, Yersinia pestis, Francisella tularensis, and a minimum of two commonly diagnosed prevalent pathogens with similar early symptoms as the three required biothreat pathogens (fever, malaise, flu-like symptoms, etc.).
At the end of the performance period, it is expected that the integrated clinical sample-to-answer multiplex platform will:
- Detect all specified pathogens directly from a blood sample without a blood culture step
- Be designed for use in a primary healthcare setting or in low resource settings
- Generate actionable diagnostic results within a maximum of two hours
In addition to the detection of pathogens from blood, multiplex diagnostic tests to detect medically important pathogens in other types of clinical samples may be proposed as appropriate for an offeror’s instrument, including saliva, sputum, urine, feces and/or other types of clinical samples. The capability to provide information regarding antimicrobial sensitivity or resistance of the pathogens is also strongly desired.
NIAID estimates that the average annual total cost (direct and indirect costs combined) for up to 3 contracts is six million dollars.
Further requirements are detailed under Solicitation Number: NIHAI2014009.