ABOUT CHALLENGE

Over one million individuals in the US have died from drug overdoses from 1999 to 2021, and rates of fatal overdoses have been increasing quickly in recent years (https://nida.nih.gov/drug-topics/trends-statistics/overdose-death-rates). This enormous death toll has strained the resources needed to track the drug epidemic accurately. Over the past 20 years, approximately 20% of drug overdose death records did not determine the drug involved. Because drug overdose death counts describing the specific drugs involved are regularly underreported, this severely delays accurate monitoring of death rates and consequently curbs public health authorities’ ability to identify threats in a timely manner and to implement effective interventions or care in communities impacted by drug overdoses.

Currently, suspected drug overdoses represent more than 1 in 6 death investigations, and both coroner and medical examiner offices are facing overwhelming caseloads that require comprehensive toxicology analysis. Therefore, there is a critical and immediate need to improve the workflow in suspected fatal overdose cases with new postmortem toxicology screening tools.

Two significant hurdles to specifying the drugs involved in suspected overdose deaths are the long lag time in obtaining comprehensive toxicology results and the growing costs of toxicology testing. The current backlog may be months long and is worsened by surging numbers of fatal overdoses, a chronic shortage of trained scientific staff, and the emergence of new synthetic drug analogs. The cost of toxicology testing is a major financial burden and is driven in large part by the expense of the analytical instruments, technical staffing, and laboratory costs. In terms of instruments used for toxicology testing, the current standards are gas chromatography-mass spectroscopy (GC-MS) and liquid chromatography-mass spectrometry (LC-MS). For LC-MS, the one-time purchase cost ranges from $350,000 for liquid chromatography-tandem mass spectrometry (LC-MS/MS) instruments to over $500,000 for liquid chromatography-quadrupole time of flight mass spectrometry (LC-QTOF-MS) instruments. Due to the high costs to set up and run a toxicology lab, most coroner and medical examiner offices do not have an in-house laboratory for toxicology, and instead, submit postmortem biological samples (e.g., blood, urine, and tissues) to a state laboratory or contract laboratory for their definitive toxicology testing. Even in the case of outsourcing, toxicology testing remains a major financial burden. Therefore, there is currently an opportunity to help coroners and medical examiners to streamline their workload with rapid and portable toxicology screening devices.

LC-MS and GC-MS are the current standards for definite toxicology testing; however, to become practical screening devices, mass spectroscopy-based devices should be more compact, economical, and simple to use. An important trend in this area is the development of miniature mass spectrometers. Point-of-need devices based on miniature mass spectrometers are currently available in the marketplace to detect trace drugs in solid samples and have proven useful for forensic detection in law enforcement and public health. As part of services for harm reduction and overdose prevention, instruments using paper spray mass spectrometry have been deployed in the community setting and used on site to test and check drug samples for individuals who use drugs. Additionally, benchtop miniature mass spectrometer systems are also being developed to analyze complex biological samples including whole blood.

Additional approaches to toxicology screening may make use of infrared (IR) spectroscopy or Raman spectroscopy; these methods are widely applied to the forensic detection of drugs in the laboratory and in the community setting. Handheld near IR spectrometers have been shown to detect cocaine in cocaine-containing case samples. As a potential step toward, a semi-quantitative screening device for roadside tests by law enforcement, infrared spectroscopy was used to detect cocaine in saliva after a one-step extraction process. Raman spectroscopy has been utilized in point-of-care devices to test and check drug samples for individuals who use drugs. For biological samples, including blood, surface-enhanced Raman spectroscopy has been shown to be able to detect specific drugs.

Immunoassays are well-known tools in toxicology screening. The dipsticks, cups, or strips can detect drugs in urine at a cost of less than $10 for an assay and can produce results in minutes. In addition, immunoassay strips are used in community settings for testing and checking drugs as part of services for harm reduction and overdose prevention. Automated immunoassay analyzers are currently used in laboratories to detect drugs and their metabolites in urine and blood samples. While a useful tool, current immunoassays are limited in their ability to quantify drug levels and limited in the breadth and specificity of drugs that may be identified with this method.

Novel emerging technologies are also encouraged, as long as they satisfy this Challenge’s intent to deliver user-friendly, cost-efficient, rapid, portable, and accurate toxicology screening devices into the marketplace.

NIDA is launching the “Cause of Death Elucidated (CODE) in Drug Overdose” Challenge to solicit ideas for novel postmortem toxicology screening devices that would improve and accelerate the workflow in suspected drug overdose death investigations.

The ideal postmortem toxicology screening devices must be able to detect and identify drugs or metabolites in samples of a decedent’s whole blood and use consumables that are stored at room temperatures. The ideal devices should be able to identify specific drugs under the drug classes of barbiturates, benzodiazepines/sedatives, cannabinoids, dissociatives, cocaine, opioids, and sympathomimetic amines found in the 2021 ANSI/ASB Standard for the Analytical Scope and Sensitivity of Forensic Toxicological Testing of Blood in Medicolegal Death Investigations (https://www.aafs.org/asb-standard/standard-analytical-scope-and-sensitivity-forensic-toxicological-testing-blood-0).

The ideas submitted to this Challenge should strive for the best possible combination of performance benefit features to optimize their performance and utility in postmortem toxicology screening.

For performance benefit features, an ideal toxicology screening device would:

• Be cost-competitive—the design of an eventual final product should give consideration to having the Manufacturer Suggested Retail Price (MSRP) that does not exceed $25,000.
• Deliver at least semi-quantitative (e.g., ranges of concentrations) results on drug concentrations—the cut off values for blood screen are presented in the 2021 ANSI/ASB Standard for the Analytical Scope and Sensitivity of Forensic Toxicological Testing of Blood in Medicolegal Death Investigations; for example, amphetamine (25 ng/mL), and fentanyl (1 ng/mL).
• Deliver results in less than 60 minutes.
• Be < 50 pounds for use in field conditions (e.g., death scene investigation), capable of operating using a power outlet or a rechargeable battery with > 1 hour life, and capable of operating in environments of 10-35°C and 25-80% relative humidity (RH). When this screening test is performed in the field, transport of biological samples is not needed; however, biological samples may be collected and transported for further toxicology testing.

Additional details on what NIDA is looking for in detection technologies are provided in the Judging Criteria and Submission Requirements sections.

NIDA is conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719]. The general purpose of NIDA is to conduct and support biomedical and behavioral research, health-services research, research training, and health-information dissemination with respect to the prevention of drug use and the treatment of drug addiction. This Challenge will improve the surveillance of drugs involved in overdose deaths and thus aligns with the NIDA mission to advance science on the consequences of drug use and addiction and to apply that knowledge to improve public health.

• Challenge Launch: July 20, 2022
• Submission Start: August 1, 2022, 9:00 AM ET
• Submission End: September 23, 2022, 5:00 PM ET
• Judging Period: September 26, 2022 to October 14, 2022
• Winners Announced: October 18, 2022

The total prize purse is up to $100,000 with up to four awards of up to $25,000 each. All winning submissions will be prominently featured on the NIDA website and via social media.

The Award Approving Official will be the Director of NIDA.

Prizes awarded under this Challenge will be paid by electronic funds transfer and may be subject to federal income taxes. NIH/NIDA will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Winners must be able to provide bank account and routing information in order to receive the cash prize funds and must be prepared to obtain additional documentation or funds transfer information from their financial institution as needed. NIDA will pay the cash prize to the Team Leader who registers and submits on behalf of a Team, and in the case of an Entity, will pay the cash prize to the Entity and not the Point of Contact.

NIDA reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, and/or (b) not award any prizes if no entries are deemed worthy.

Participants may be an individual, a team of individuals, or an entity. Each team that enters the Challenge is required to identify a Team Leader who submits a solution on behalf of the Team. The Team Leader is responsible for all communications with the Challenge sponsors and, in the event of winning a cash prize, will be paid the prize in full. Each entity that enters the Challenge is required to identify a Point of Contact who submits a solution on behalf of the Entity. The Point of Contact is responsible for all communications with the Challenge sponsors. In the event of winning a cash prize, the prize will be paid directly to the Entity, not to the Point of Contact.

Each submission for this Challenge requires a complete Submission Package. All submissions must be in English. The participants must not use the HHS logo or official seal, or the logo of NIH or NIDA in the submissions and must not claim federal government endorsement. The Submission Package has a page limit of up to 10 pages, excluding entry form and references. Figures, images, graphs, tables, and schematics are counted in the 10-page document limit for the Title, Summary, and Descriptions of Technology, Performance, and Scalability Potential sections outlined below. The Submission Package should be submitted via the Contestant Portal.

The Submission Package should consist of:

1. 1. Entry Form: Participant information such as name, affiliation, contact information.
   2. Title: Provide a title for the proposed solution.
   3. Summary: In one page or less, summarize the proposed solution.
   4. Description of Technology.
      1. Summarize the scientific evidence that supports the proposed solution.
      2. Describe how postmortem whole blood samples would be collected and prepared for testing, using established methods as the basis for scientific support.
      3. Describe the hypothetical accuracy of the proposed solution and the level of quantitation (semi-quantitative or quantitative) in the analysis of whole blood samples. Describe the potential specificity.
      4. Describe the technical feasibility of your technology for use in postmortem toxicology testing. Provide images and/or schematics to support the technical feasibility of a future proposed device.
   5. Description of Performance.
      1. Describe the physical form that the proposed solution may take, given it should have the ability to be used in the field (weight, size, portability, power source, etc.). Describe the proposed solution’s characteristics that would assure an enhanced accessibility (e.g.,  price, complexity, additional equipment, and requirements for temperature control).
      2. Describe the potential extent and number of drugs and/or their metabolites that may be identified. The description should cover all the drugs listed under the drug classes of barbiturates, benzodiazepines /sedatives, cannabinoids, dissociatives, cocaine, opioids, and sympathomimetic amines that are found in the 2021 ANSI/ASB Standard for the Analytical Scope and Sensitivity of Forensic Toxicological Testing of Blood in Medicolegal Death Investigations.
      3. Describe potential time to results.
   6. Description of Scalability Potential.
      1. Describe how the proposed solution can be designed for scale up and could be developed into a real-world product.
      2. Describe the estimated cost range to manufacture the proposed solution as a final product in the future.