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Planning tools for therapeutic, vaccine, and diagnostic and device candidates
TPPs define the ideal attributes of products of interest to BARDA and show the ultimate goals of the proposed development effort such as disease indication, patient population, delivery mode, treatment duration, treatment regimen, and standards for clinical efficacy. Ideally, these products will be approved, licensed, or cleared by the U.S. Food and Drug Administration (FDA). TPPs provide structure for the scientific, technical, and clinical information required to achieve a desired outcome and address an unmet clinical need. They also provide stakeholders with a clear vision of the product objectives and help guide research and development decisions.
Concept of Operations/Mission Space: Anthrax is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria known as Bacillus anthracis which can cause severe illness. The U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC) have classified B. anthracis as a select agent that has the potential to pose a severe threat to public health and safety and as a Category A Bioterrorism Agent/Disease. Vaccines against disease caused by B. anthracis are critical to preventing mortality in the event of an accidental or intentional exposure. While anthrax vaccines for post-exposure prophylaxis (PEP) are currently licensed, having a single-dose regimen vaccine, used in combination with antibiotics, will be an important component of a response to a public health emergency involving anthrax.
BARDA’s primary mission in anthrax vaccines is focused on a PEP indication to ensure protection of the U.S. population if exposed to anthrax. This is part of the latest step in longstanding efforts to strengthen the nation’s ability to respond to health security threats and is a critical part of BARDA's comprehensive strategy to address the threat of anthrax by investing in the advanced research and development and procurement of vaccines, therapeutics, and diagnostics.
Target Product Profile
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Product Properties |
Optimal Attributes |
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Indication for use |
PEP of disease following suspected or confirmed B. anthracis exposure, when administered in conjunction with recommended antibacterial drugs. |
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Target population |
All adults, and pediatrics over 12 months of age. |
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Safety/Reactogenicity |
Safety and reactogenicity suitable for use in all populations as PEP, at least under potential U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA). |
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Clinical efficacy |
Greater than 70% in a PEP scenario with lower bound 95% confidence interval >40% as inferred by neutralizing antibody titers. |
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Nonclinical efficacy (based on the Animal Rule) |
Demonstration of efficacy against 200 median lethal dose (LD50) B. anthracis Ames strain spores in African green monkeys. |
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Onset of protection |
Onset of protection within 2 weeks. |
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Duration of protection |
Duration of protection of 3 years or more. |
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Dose regimen |
Single-dose regimen. |
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Route of administration |
Injectable (intradermal (ID), intramuscular (IM), or subcutaneous (SC)) using volumes suitable for a single injection. Oral, intranasal, or other needle-free approaches preferred. |
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Co-administration with other medical countermeasures |
Vaccines are compatible to co-administration with appropriate antibacterial drugs. |
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Shelf life |
Greater than 5 years at long-term temperature, greater than 24 hours at room temperature for clinical use. |
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Storage temperature (long-term) |
Room temperature > 2-8oC > -20oC. |
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Storage temperature (clinical operations) |
Room temperature >2-8oC. |
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Regulatory pathway |
Candidate vaccine is licensed by the FDA. |
Concept of Operations/Mission Space: BARDA’s mission is to develop and procure medical countermeasures to protect the American public. Vaccines against filoviruses such as Ebola virus (EBOV) and Marburg virus (MARV) will be a critical medical countermeasure to prevent the spread of disease through the U.S. population in the event of a filovirus emergency. An effective vaccine increases domestic preparedness through vaccination of healthcare workers and responders associated with potential Ebola Treatment Centers, as well as laboratory workers at risk of exposure. The U.S. may also play a role in any response to a global health emergency to help stop the spread at its source. The national response posture will be enhanced by an effective vaccine, allowing the vaccination of at-risk individuals upon detection of an outbreak, including healthcare workers, front line responders, and contacts of identified cases.
Filoviruses can cause severe hemorrhagic fever in people and nonhuman primates. All filoviruses are classified by the U.S. Department of Health and Human Services as select agents that have the potential to pose a severe threat to public health and safety, and by the U.S. Centers for Disease Control and Prevention as Category A Bioterrorism Agents/Diseases. In 2022, there were four filovirus outbreaks: a MARV outbreak in Ghana; two EBOV outbreaks in the Democratic Republic of Congo; and a Sudan virus (SUDV) outbreak in Uganda. Currently, there is no licensed vaccine against SUDV or MARV. Strengthening our ability to respond to health security threats posed by filoviruses is a critical part of the BARDA strategy.
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Product Properties |
Optimal Attributes |
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Indication for use |
Prevention of filovirus infection in response to a disease outbreak. For active immunization of persons considered at-risk to protect against disease caused by filoviruses. |
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Target population |
Adults and pediatrics (6 months of age and above) at risk of disease caused by potential exposure to filovirus. |
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Safety/Reactogenicity |
Acceptable safety profile with rates of fever comparable to placebo. |
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Breadth of protection |
Monovalent (protection against all strains within a given species). |
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Clinical efficacy |
Greater than 80% efficacy in preventing disease; or point estimate of 80% based on immunogenicity threshold with a lower bound of a 95% confidence interval >50%. |
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Nonclinical efficacy (based on the Animal Rule) |
Demonstration of efficacy against 1000 plaque-forming unit (PFU) intramuscular (IM) challenge in cynomolgus macaques. |
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Onset of protection |
Rapid onset of protection within 2 weeks. |
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Duration of protection |
Confers long-lasting protection of 3 years or more and can be maintained by booster doses (or inferred by clinical immunogenicity). |
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Dose regimen |
Single-dose regimen. |
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Route of administration |
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Serial administration with other filovirus vaccines |
Monovalent vaccines against each filovirus should not interfere with effectiveness of monovalent vaccines against other filovirus strains. |
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Shelf life |
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Storage temperature (long-term) |
Room temperature > 2-8°C >-20 °C |
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Storage temperature (clinical operations) |
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Freeze-thaw logistics |
Stable after 3 or more freeze-thaw cycles. |
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Regulatory pathway |
Candidate vaccine is licensed by the FDA. |
Vaccines against smallpox are critical to protecting the American public and preventing the spread of the disease through the U.S. population in the event of a smallpox emergency. Additionally, a smallpox vaccine that enables the prevention of disease caused by other orthopox-viruses (such as mpox) is an added benefit.
The transmissibility and mortality associated with variola virus emphasize the critical requirement for the formation and maintenance of a sufficient stockpile of vaccine to rapidly and effectively respond to a smallpox emergency. Additionally, preparedness should include prophylactic countermeasures for those at elevated risk for smallpox exposures, including lab workers and deployed military personnel.
Target Product Profile
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Product Properties |
Optimal Attributes |
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Indication for use |
Prevention of smallpox disease caused by variola virus. |
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Target population |
All individuals > 12 months of age. |
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Safety/Reactogenicity |
Safety and reactogenicity suitable for use in all populations. |
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Clinical efficacy |
Efficacy inferred from historical smallpox vaccines with high efficacy or immune response commensurate with vaccines with demonstrated high efficacy. |
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Onset to protection |
Onset to protection within 2 weeks. |
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Duration of protection |
Antibody response and protection of 3 years or more. |
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Dose regimen |
Single-dose regimen. |
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Route of administration |
Injectable (intradermal (ID), intramuscular (IM), or subcutaneous (SC)) using volumes suitable for a single injection. |
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Shelf life |
Greater than 5 years at long-term storage temperature. |
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Storage temperature (long-term) |
Room temperature > 2-8oC > -20oC. |
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Storage temperature (clinical operations) |
Room temperature >2-8oC. |
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Regulatory pathway |
Candidate vaccine is licensed by the U.S. Food and Drug Administration (FDA). |
Looking ahead to potential health security threats on the horizon, BARDA has the following performance attributes in mind for the next generation of vaccines:
1 Sustainable technologies applicable to national preparedness efforts as well as routine care spaces
The sustainability of medical countermeasures is a critical issue. Investing in novel vaccine platform technologies that are applicable to the commercial space can help further improve the potential sustainability of U.S. government vaccine programs and enhance the national response posture.
2 Vaccines that can be rapidly brought to scale to meet emergency need
It is critical to invest in vaccine manufacturing infrastructure that is resilient, surge-capable, and flexible, which also prioritizes increased domestic capacity and secures supply chains. The expansion of the domestic supply chain will help ensure that life-saving vaccines are available for mass vaccination during a public health emergency and can enable more consistent production processes and training.
3 Agile technologies that can pivot in response to new threats
We are interested in technologies that are effective across a diverse threat space and can quickly be pivoted against a new threat. This may enable a production model in which a steady state can consist of domestic production of different vaccines in different suites at a smaller scale to establish initial stockpiles. If a novel outbreak were to occur, then all suites could be turned over relatively quickly to produce the vaccine needed.
4 Robust and durable disease protection
Protection against severe disease is essential, and protection against infection is a more ideal result. For those viruses capable of extensive human-to-human transmission, and thus subject to variants commonly arising, the breadth of protection across the antigenic space will also be crucial. Ideally, vaccines will be administered in a single dose and reach TPP efficacy targets.
5 Acceptable safety/reactogenicity profile
The acceptable safety/reactogenicity profile must be as close to the placebo as possible. We are targeting vaccines that can be used in as many populations and scenarios as possible, based on the regulatory decision. However, safety profiles will always be a key consideration for any vaccine investments, regardless of vaccination campaign approach.
6 Equitable vaccine access
When developing new vaccines, it is critical that we expand the eligible populations as soon as feasible to ensure equitable access to vaccines. This will involve improving clinical trials by balancing participant demographics by race and gender, but also enable moving into special population such as older subjects and pediatrics down to six months of age or even younger when feasible and appropriate.
7 Improved operational logistics
Technologies with improved operational logistics, specifically the shelf life, cold chain, and ease of delivery (such as needle-free technologies), will be important to the next public health emergency response. It is crucial to have flexible technologies and formulations that can utilize the same manufacturing processes across multiple threats and also facilitate rapid fill finish capacities. Additionally, technologies that can enable storage at refrigerated or room temperatures would add flexibility to the back end of any vaccine response. Stability data must be gathered from the prototype vaccine to help inform shelf-life and vaccine formulation.
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Concept of Operations/Mission Space: Safe and effective antimicrobial drugs that are available for all patient populations are critical to national health security preparedness. When responding to public health emergencies and mass casualty incidents, infections involving multidrug-resistant organisms (MDROs) can complicate patient care and recovery. Antimicrobial resistance (AMR) also poses a risk to our ability to respond to biothreat infections due to limited treatment options, particularly for special populations—including pediatrics. BARDA is interested in drug candidates with direct activity against not only multiple strains of one or more biothreat pathogens (Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, and Burkholderia pseudomallei) but also drug-resistant bacteria responsible for secondary infections that can occur following a chemical/biological/radiological/nuclear (CBRN) incident, pandemic influenza, or an emerging infectious disease response. Though candidates with dual activity are preferred, candidates with activity against only drug-resistant secondary bacterial infections will also be considered. Infections of greatest interest are hospital- or ventilator-associated/community-acquired bacterial pneumonia (HABP/VABP/CABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), acute bacterial skin and skin structure infections (ABSSSI), and complicated urinary tract infections (cUTI). BARDA is particularly interested in drug candidates that treat infections caused by the MDROs identified by the Centers for Disease Control and Prevention (CDC) as serious and urgent threats. BARDA’s Antimicrobials Program aims to minimize the morbidity and mortality caused by biothreat pathogens as well as secondary infections, including those caused by MDROs, that may be encountered during a CBRN incident, pandemic influenza, or an emerging infectious disease response. The Antimicrobials Program seeks to accelerate innovation and product development through public-private partnerships that support the advanced research, development, manufacture, regulatory approval, and availability of novel antimicrobial candidates against MDROs. Overarching Goal:
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Concept of Operations/Mission Space: Critical to BARDA’s goal of preparedness against known national security threats or newly emerging infectious diseases is the availability of safe and effective antifungal drugs for all patient populations During public health emergencies and mass casualty incidents, secondary infections involving drug-resistant fungi can complicate patient care and recovery. Also, antifungal resistance poses a risk to our ability to respond to biothreat infections due to limited treatment options, particularly for special populations—including pediatrics. BARDA’s Antimicrobials Program aims to minimize the morbidity and mortality caused by biothreat pathogens as well as secondary infections, including those caused by drug-resistant fungi, that may be encountered during a chemical/biological/radiological/nuclear (CBRN) incident, pandemic influenza, or an emerging infectious disease response. BARDA seeks to accelerate innovation and product development through public-private partnerships that support the advanced development, manufacturing, regulatory approval and availability of novel antifungal candidates against drug-resistant fungi to ensure the United States (U.S.) government is adequately prepared to respond to any public health emergency. BARDA is interested in developing first-in-class, broad-spectrum antifungal drug candidates with novel mechanisms of action that target drug-resistant Candida species, including C. auris, and drug-resistant Aspergillus species. Drug candidates that also demonstrate activity against rare molds, such as Mucorales, are of interest. Overarching Goal:
a The route of administration must be amenable to infection/indication. |
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BARDA supports the advanced development, manufacturing, and regulatory approval of medical countermeasures against high consequence chemical, biological, radiological and nuclear threats, pandemic influenza, and emerging infectious diseases. Botulinum neurotoxin (BoNT) is a priority threat within this portfolio. BoNTs are the most potent and lethal toxins known. The toxins are produced by spore‐forming gram‐positive bacteria belonging to the genus Clostridium, a diverse group of bacteria. Botulinum neurotoxins are classified into seven serotypes, including BoNT/ A–G, each of which is produced by a different strain of Clostridium botulinum. The botulinum toxins block nerve functions and can lead to respiratory and muscular paralysis (also known as botulism). Current U.S. Food and Drug Administration (FDA) approved treatments for botulism consists of an intravenous (IV) infusion of a heptavalent equine antibody-based antitoxin. It is likely that an optimal treatment regimen would consist of a product that neutralizes the toxin that is in circulation and, or in combination with a second product, neutralizes the toxin or blocks toxin effects once the toxin is taken up by the neurons. New products with a similar mechanism of action to the current licensed product should offer significant improvements (e.g., cost, manufacturability, route of administration, storage, and potency) over the licensed product. However, the largest clinical and economic benefit would derive from the ability to reverse or block paralysis and thus reduce the need for long-term supportive care (weeks to months) in a respiratory intensive care unit. This may be achieved by blocking the activity of the BoNT once it reaches its target – the cytoplasm of the peripheral cholinergic nerve cell. BARDA is also interested in approaches that target the host to reverse or mitigate the effects of toxin exposure (intoxication).
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Concept of Operations/Mission Space: Acute respiratory distress syndrome (ARDS) is a life-threatening lung injury primarily caused by severe pneumonia and sepsis due to bacterial and viral infections (e.g., influenza), leading to high morbidity and mortality in hospitalized patients. There are no FDA-approved treatments for ARDS. Identifying treatments for patients with ARDS remains challenging because patients who have ARDS are typically highly diverse in terms of demographics and/or clinical characteristics. Although many drugs for ARDS have been tested previously in clinical trials with no success, post-hoc positive efficacy signals have been identified in subsets of patients with ARDS. Identifying and enrolling a more homogeneous patient population could potentially lead to better study outcomes. Additionally, there is an urgent need to understand the clinical and biological features to better classify patients into phenotypically-defined cohorts that might be more responsive to a given therapy. To better prepare for pandemics caused by respiratory pathogens and provide treatments that can benefit ARDS patients right now, BARDA is interested in developing and seeking FDA approval of treatments for ARDS that are pathogen-agnostic. The following goals outline the Influenza & Emerging Infectious Diseases (EID) Division’s preferred characteristics for ARDS therapeutic treatments:
This TPP is intended to highlight potential product attributes that may be useful for sponsors to consider; it is not intended to be used as regulatory guidance or as evaluation criteria for contract award.
*Note: Clinical outcomes for mild ARDS have not been defined. A range of outcomes may be acceptable for regulatory approval. |
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During an infectious disease outbreak or pandemic, medical countermeasures that are rapidly scalable, low cost, and broadly available can help save lives. Digital tools like smartphone and web-based applications or artificial intelligence and machine learning (AI/ML) algorithms can provide an important first line of defense to augment traditional approaches in the face of health security threats. These digital guidance tools could empower individuals with actionable information about their symptoms and infection status so that they can self-isolate and seek medical care if appropriate. The advantages of digital medical countermeasures may include rapid turnaround time, lower cost, sustainability, portability, and ease of use. In addition, digital MCMs are scalable and do not require additional devices and consumables.
Audio-capture and advanced AI/ML analytics of audio-frequency signals from smartphones or other devices can support medical diagnostics from vocalizations such as speaking or coughing. Digital apps using a smartphone microphone can be used to detect the presence or absence of specific disease signatures such as COVID-19, influenza, respiratory syncytial virus (RSV), or tuberculosis. Digital diagnostic apps could be an essential tool for healthcare providers and individual app users alike. Through an app, users could receive a quick and accurate assessment and seek care earlier, thereby reducing the spread of disease and improving overall public health.
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Product Properties |
Minimal Attributes |
Optimal Attributes |
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General Capability Description |
A digital diagnostic app that uses cough audio as the input for screening or detection of respiratory infections |
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Intended Use and Setting |
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Target Population |
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Description of System (Device Architecture) |
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Clinical Performance Characteristics |
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Pathogen and Threat Targets |
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Specimen/Data Collected |
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Audio acceptance, quality assurance |
Demonstrate that the system can evaluate the quality of cough audio to determine if it is suitable for use with the AI/ML algorithm |
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Regulatory Compliance |
Data use regulatory compliance |
FDA cleared or approved, as appropriate |
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Security and Privacy |
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Cost |
Different cost models: individual users, subscriptions for corporate, insurers, and government |
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During an infectious disease outbreak or pandemic, medical countermeasures that are rapidly scalable, low cost, and broadly available can help save lives. Digital tools like smartphone and web-based applications or artificial intelligence and machine learning (AI/ML) algorithms can provide an important first line of defense to augment traditional approaches in the face of health security threats. These digital guidance tools could empower individuals with actionable information about their symptoms and infection status so that they can self-isolate and seek medical care if appropriate. The advantages of digital medical countermeasures may include rapid turnaround time, lower cost, sustainability, portability, and ease of use. In addition, digital MCMs are scalable and do not require additional devices and consumables.
Smartphone cameras can capture an image of a skin condition at sufficient resolution to support advanced analytics. AI imaging analysis frameworks now exist for the advanced detection and identification of several skin conditions. Digital screening apps could be an essential tool for healthcare providers and individual app users alike. Through an app, users could receive a quick and accurate result and seek care earlier, thereby reducing the spread of disease, supporting broader disease management efforts, and improving overall public health.
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Product Properties |
Minimal Attributes |
Optimal Attributes |
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General Capability Description |
A digital diagnostic app that analyzes images of a user’s skin lesions and rashes to detect diseases, such as smallpox and other BARDA priority pathogens |
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Intended Use and Setting |
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Target Population and Use Setting |
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Description of System (Device Architecture) |
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Clinical Performance Characteristics |
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Pathogen and Threat Targets |
Infectious disease pathogens and/or CBRN threats with skin conditions, such as smallpox and other BARDA priority pathogens |
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Specimen/Data Collected |
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Image acceptance, quality assurance |
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Regulatory Compliance |
Data use regulatory compliance |
FDA cleared or approved, as appropriate |
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Security and Privacy |
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Cost |
Different cost models: individual users, subscriptions for corporate, insurers, and government |
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Most of today’s clinical diagnostic tools are designed to detect the presence of a specific and known pathogen. These targeted assays – like the PCR and antigen tests that have become widely used during the COVID-19 pandemic – meet a critical need for diagnostics. Yet targeted diagnostic tests are reactive by design and typically are not available until weeks or months after an outbreak of an unknown pathogen has begun. Additionally, significant time and effort are needed to develop, verify, and validate such tests and obtain regulatory approval. In the early days of a public health emergency of pandemic potential, early availability of patient tests is crucial. Having an agnostic diagnostic test – a diagnostic that can identify any known or novel pathogen when a traditional targeted diagnostic is not yet available – can help accelerate public health response until more cost effective, easier to perform testing solutions can become available. Next generation sequencing (NGS) technology is a promising platform since it is already being used for surveillance and variant detection.
However, NGS has not yet been established as a medical diagnostic standard of care. Metagenomic NGS (mNGS) technology could be leveraged for development of diagnostic tests that can sequence all types of DNA or RNA and can use that information to identify any pathogen that is present. Expanding commercial mNGS-based agnostic diagnostic capabilities could enable early identification of infections caused by pathogens of concern and could also broaden the capability to identify the disease variant of a patient’s infection to better inform care. The emergence of a pathogen with pandemic potential is highly likely, and public health and response communities will need comprehensive diagnostic tests to quickly detect the next novel pathogen. Ideally, having U.S. Food and Drug Administration (FDA) cleared in vitro diagnostics (IVD) test(s) capable of rapidly detecting any pathogen would also be useful in complicated hospitalized cases of unknown etiology. Accelerating the development and regulatory clearance of these mNGS-based agnostic diagnostics could help bolster U.S. preparedness for future outbreaks across a variety of health care settings.
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Product Properties |
Minimal Attributes |
Optimal Attributes |
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General Capability Description |
A metagenomic next generation sequencing (mNGS)-based test that can detect any respiratory viral pathogen, including novel and emerging, from common human respiratory sample types |
An mNGS-based test that can detect any pathogen, including novel and emerging, from any human sample type for any infectious disease condition
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Intended Use |
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For use in routine diagnosis of any type of infection via a single test in point-of-care or hospital settings |
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Description of System (Device Architecture) |
A complete sample-to-answer solution; including sample processing, enrichment of target sequences or removal of interfering nucleic acids, library generation, sequencing, bioinformatics analysis, and reporting of results in a clinically relevant format |
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Clinical Performance Characteristics |
Positive predictive value (PPV) > 95% and negative predictive value (NPV) > 99%, sensitivity=> 95%, specificity > 95%, and limit of detection < 1000 genome equivalents/mL |
Positive predictive value (PPV) > 98% and negative predictive value (NPV) > 99%, sensitivity=> 95%, specificity > 99%, and limit of detection < 10 genome equivalents/mL |
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Pathogen Targets |
All pathogenic respiratory viruses including emerging/novel viruses |
All existing and emerging/novel pathogens including bacterial, viruses, fungi, and parasites |
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Specimen Type |
Respiratory samples including but not limited to: nasopharyngeal, nasal, bronchoalveolar lavage (BAL), saliva, and other upper or lower respiratory samples |
Any human sample type |
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Time to Results |
< 24 hours |
<8 hours |
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Target Population Being Tested |
Patients with acute symptoms of viral respiratory infection, e.g., the common cold or influenza-like illness |
Patients with a suspected infectious disease and/or unknown etiology, including hospitalized patients |
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Target Use Setting |
Clinical labs, public health labs, hospitals |
Clinical labs, public health labs, hospitals, and point-of-care |
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Target Analyte |
DNA and RNA from all respiratory viruses
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DNA and RNA from all pathogens including bacteria, viruses, fungi, and parasites |
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Result Output |
A clinically relevant report based on the bioinformatics analysis of mNGS data that qualitatively reports the viral pathogen(s) most likely to correlate with a patient’s history and other diagnostic information. |
A clinically relevant report based on the bioinformatics analysis of mNGS data that quantitatively reports (e.g., viral or pathogen load) the pathogen(s) most likely to correlate with a patient’s history and other diagnostic information. |
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Regulatory Compliance |
Emergency Use Authorization by the FDA for use in a pandemic or emerging infectious disease outbreak |
De Novo classification or 510(k) clearance by the FDA |
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Cost/Panel |
Equivalent to or less than existing molecular test panels |
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Surveillance |
Pathogen data transfer to public health authorities for surveillance with appropriate security and privacy. |
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