The Joint Project Management Office for Medical Countermeasure Systems (JPM-MCS), under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) has issued a Request for Information to support the Joint Product Director for Diagnostics (JPdM Dx) in strategic planning for development of the Next Generation Diagnostics System (NGDS) Increment 2 acquisition.
JPM-MCS is interested in collecting information from companies who are currently in the U.S. domestic healthcare market or are considering a future entry into the market for FDA-cleared diagnostics for human diseases caused by exposure to biological threat agents. JPM-MCS is specifically interesting in information about systems that are complementary to the Increment 1 NGDS sample-to-answer molecular (PCR) diagnostic platform used in forward deployed clinical laboratories, combat support hospitals and ships.
Information gathered will be reviewed as part of a market survey in support of the NGDS Increment 2 acquisition program planned to begin August 2014.
Biological threat types include:
- Pathogenic bacteria, DNA and RNA
- Biological toxins (bacterial, plant and animal derived)
Applications for these technologies and systems include: use at small clinical laboratories providing centralized support to fixed site and mobile hospitals less than 200 beds; point of care diagnostics in a CLIA-waived setting; HIPAA-Compliant communications and data processing tools supporting remote data analysis/interpretation of point of care sample analyses; and non-invasive or very low invasive population screening tools to identify people who may benefit from follow-on diagnostic testing. Patients may be tested pre-symptomatically or within 12 to 120 hours of exhibiting symptoms, depending on location of the clinic or laboratory.
The RFI details minimum threshold and ideal system characteristics, such as:
- Portable, total system weight 0.5 lbs -15 lbs
- Safe for use with BSL 4 agents (low risk of aerosolizing sample material)
- Open Architecture supporting 3rd party assay design and development
- Single Sample Time to Result objective of 5 minutes, no more than 30 minutes
- Electronically enabled for data archiving and communications
- Detection of agent specific proteins and biomolecules
- Detection of disease specific host biomarkers
- High specificity
- Supportive of syndrome based diagnostics with endemic diseases
- Aligned with vaccines and therapeutics in production or development
- Exiting or emerging FDA regulatory framework to support development and 510k clearance
- Single use consumable or reusable, adaptable instrument/assay based system
- FDA cleared for in-vitro diagnostics or sufficiently mature to begin FDA Clinical Trials no later than January 2016
Further details are available under Solicitation Number: Solicitation Number: W911QY-13-RFI-NGDSI2.