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Operation Saline Shield

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In the wake of September 2024’s Hurricane Helene, storm damage to one of the nation’s largest intravenous (IV) fluid manufacturing facilities posed a major threat to hospital and clinic operations across the United States. To prevent a healthcare crisis, IBMSC launched Operation Saline Shield, a coordinated federal response to stabilize the national IV fluid supply.

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Bag of Saline

Carbon Black Pipette Tips

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Every month, a new U.S.-based facility will produce 1,210 tons of Carbon Black, a high-performance compound engineered for chemical resistance, dimensional stability, and clean, contaminant-free processing. The material will be used to make pipette tips, which are essential for medical tests.

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Pipette Tips

On-Demand IV Fluid

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An automated, point-of-care, sterile saline manufacturing system that may help prevent or mitigate IV fluid shortages in the U.S. is under development and has started two demonstration projects. The new technology could produce up to 500 bags of IV fluid per day.

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IV Fluid

Expanding Research and Manufacturing Facilities to Create 15 Critical Products:

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New state-of-the-art manufacturing ecosystem will manufacture drugs in several critical therapeutic classes, including cardiovascular, pain and sedation, and respiratory. This U.S.-based facility will take 15 drugs completely through the pharmaceutical manufacturing lifecycle, from development to production.

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Manufacturing Facility Team Photo

Diagnostic Test Membranes

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Launched first and only nitrocellulose membrane production facility. Nitrocellulose membranes are used for the production of a wide range of medical tests - from heart attack tests to test that diagnose infectious diseases. This facility plans to produce 600-700 kilometers of lateral flow membrane annually.

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Millport Sigma

Ushering in a New Era in Ambulatory Care: AI-Powered Rapid Blood Tests at the Point of Need

Ushering in a New Era in Ambulatory Care: AI-Powered Rapid Blood Tests at the Point of Need

Most infections start and often worsen in the community, but most tests are confined to clinical and hospital laboratories. Bringing testing closer to the patient leads to faster diagnoses, allowing patients and front-line providers to take action faster. The impacts could be transformative for the delivery of care, especially during seasonal surges of respiratory viruses, pandemics, and disasters. That’s why BARDA continues to partner with industry to advance host-based diagnostics, and through a recent partnership is harnessing artificial intelligence (AI) to bring meaningful results to front-line providers in less than three minutes.

BARDA’s Host-Based Diagnostics Program is advancing a new generation of tests that harness the body’s biological response to infection. By decoding unique host-response signatures, these innovative blood tests provide rapid, actionable insight into infection severity, empowering clinicians with critical information when and where it matters most.

Medical professional assisting patient in car

 

AI is central to this transformation. A BARDA-supported test, developed by Ad Astra Diagnostics (AAD), shows the power of AI-enabled diagnostics in action. In late 2023, AAD received FDA 510(k) clearance for its QScout® RLD test, which analyzes a small blood sample using AI-powered digital imagery. When inserted into the QScout® Lab analyzer, advanced algorithms evaluate cellular morphology in under three minutes—delivering rapid insight into patient status at the point of need.

AAD is now preparing the next-generation QScout® CBC test on the second generation of the QScout® Lab platform, designed to accommodate both capillary and venous blood samples in a smaller, rugged format. With enhanced usability and portability, this system will be built for real-world conditions, supporting care in ambulances, rural clinics, urgent care centers, and disaster response environments. AI-driven interpretation of cellular imagery is also being expanded to support early identification of sepsis, further strengthening BARDA’s long-standing investment in infection severity diagnostics, resulting in three FDA-authorized products to date.

This matters deeply for communities. More than 85 percent of sepsis cases and 73 percent of pediatric sepsis cases are present upon admission to the hospital, indicating that patients are often progressing to severe illness before reaching the emergency room. Bringing advanced, AI-enabled diagnostics into community settings allows providers to identify high-risk patients earlier, communicate critical information ahead of hospital arrival, and initiate appropriate care without delay.

Imagine paramedics testing a blood sample in an ambulance and transmitting precise, AI-interpreted severity data from a complete blood count (CBC) to the emergency department before arrival . This level of real-time clinical insight is game-changing for patients and providers alike. The CBC test could help providers identify patients who are at risk for sepsis and enable providers to triage patients more effectively.

By investing in portable, AI-enabled host-response diagnostics, ASPR is strengthening national health security from the ground up and equipping communities with the tools to triage faster, manage resources more effectively, and improve patient outcomes before crises escalate. This is preparedness in action: bringing advanced technology directly to the front lines to protect Americans wherever they live and seek care.

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