Call to action: Let’s integrate innovative and highly effective screening workflows nationwide to significantly enhance our H5N1 surveillance capabilities.
The latest developments in the H5N1 situation – 58 confirmed U.S. human cases of H5N1, including in a child in California; a British Columbia teen recently hospitalized; potential for the current H5N1 virus strain to transmit by air compared to older strains; and detection of the virus in pigs – are not just a wake-up call, but a call to action. Now is the time to elevate our response to this outbreak by creating better tools.
While the CDC’s calls for expanded bird flu testing and test development are commendable, they’re not enough. By integrating innovative, highly effective, and readily available digital screening workflows nationwide, we can significantly enhance our surveillance capabilities against H5N1.
As CEO of Primary.Health, I’ve led our evolution from a COVID-19 response platform to a proven public health technology partner serving nearly 7 million patients across 28 states. By closely collaborating with frontline physicians during the pandemic, we developed solutions that facilitated 13.7 million tests and 1.5 million vaccinations through 10,000+ sites. Our success bridges Silicon Valley innovation with public health infrastructure needs – whether implementing statewide vaccination programs in Colorado and North Dakota or partnering with vaccine makers to improve vaccine accessibility. This extensive experience with both healthcare providers and government agencies informs my recommendations for strengthening our public health systems through practical, scalable technology solutions.
1. Modernize Public Health Labs
Modernization of public health laboratories (PHL), the hub of emergency preparedness, means equipping labs with the customized software tools they need and desire. Improving digital ordering systems and enabling digital sample diversion can accelerate the real-time scaling of laboratory capacity. For example, PHLs that have adopted electronic laboratory reporting (ELR) systems during health emergencies have significantly improved data accuracy and turnaround times. It’s time to move away from paper and fax for test reporting and invest in modern digital tools that can automatically route samples between labs (digital diversion); handle large batches of data at once (bulk import tools); give patients secure access to results online (patient portals); let doctors order and receive tests electronically (Electronic Test Orders and Results (ETOR); and convert paper records to digital text (optical character recognition). These innovations will speed up lab testing while working seamlessly with current laboratory systems.
Unfortunately, progress toward full digital integration of PHLs by public health departments has lagged. That’s why renewed commitment from PHAB and others, along with solid political support, are essential to strengthen collaborations with providers, labs, and vendors.
2. Develop Lab-Agnostic Self-Collection Kits
Envision easy-to-use self-collection kits available nationwide, designed using requirements gathered from public health experts and universal to all laboratories. This transformative approach would make sample collection more efficient and cost-effective and dramatically bolster our surveillance efforts.
Implementation would involve partnering with employers, pharmacies, mail-order systems, and community centers for broad distribution and access. By ensuring kits are user-friendly and come with clear, multilingual instructions, we can improve the accuracy of self-collected samples. Further, integrating telehealth support can assist users, enhance the reliability of the collected data, and improve access to timely treatment. We experience this in real time throughout our community wellness clinics, where telehealth nurse practitioners provide immediate follow-up.
3. Deploy Advanced Metagenomic Surveillance Technologies
For next-level surveillance, I propose harnessing the power of self-collected metagenomic frontline surveillance screenings. For example, UCLA SwabSeq’s high-throughput sequencing platform can detect over 20 viruses — including H5N1 — from a single sample; one day, it will detect 100+ viruses and bacteria from one sample. Its scalability, rapid results, and ability to process thousands of samples simultaneously – as evidenced in UCLA pilot studies – make it a strong candidate for nationwide implementation now.
UCSF’s Chan Zuckerberg Biohub and the Broad Institute also provide metagenomic work and have available kits. Metagenomic diagnostics is now “old tech” that needs broad adoption; healthcare is notoriously slow at adopting new things, and we need a few more policy leaders who can fix this.
Pre-pandemic experts credit high-throughput sequencing with delivering precision public health. We should deploy this readily available technology in provider waiting rooms and community sites today to significantly enhance our surveillance testing capacity and speed. This would give us front-line capability for any emerging virus, avoiding the need for expensive, complex, and virus-specific test development. While the idea of an inexpensive, sensitive test programmable for any virus target is novel, it is not new; it should be prioritized for implementation by the CDC, FDA, and established lab industry. For more background on healthcare’s slow adoption of disruptive testing capabilities, Dr. Eric Topol provides a concise summary of the challenges of scaling up and adopting metagenomic methods to combat sepsis.
4. Purchase Economically Viable Rapid Testing
Providing affordable tests is crucial for effective surveillance, which is essential in managing threats and reducing transmission. I propose equipping community groups with validated H5N1 rapid kits for non-clinical settings to make screening both accessible and affordable. Companies such as Scout Health, Aptitude Medical Systems, and Alveo Technologies have developed sensitive and durable self-testing equipment suitable for real-world use.
To ensure a diverse range of diagnostic tests, the CDC should more quickly and openly distribute patient virus samples to many diagnostic manufacturers for test validation and establish a program to purchase initial inventories. While the recent CDC award to Alveo is commendable, awarding the contract to a single company is risky. We advocate for funding multiple diagnostic manufacturers.
To promote wider use of rapid testing, the CDC should encourage all diagnostic makers to follow a Target Product Profile, or TPP (see suggestion 6); receive free support for developing new viral targets; and establish a purchasing program for initial inventories. This approach would enhance the market availability of these tests.
5. Pre-Register Vulnerable Populations
By creating a prioritized vaccine waitlist for at-risk groups such as farmworkers, we can streamline immunization efforts the moment targeted H5N1 vaccines become available. To do so, we would collaborate with local organizations, farmworker associations, and community leaders to reach and register vulnerable populations. Tapping public health databases and secure digital platforms is another way to more efficiently manage the waitlist.
6. Improve Procurement with Target Product Profiles (TPPs)
Target product profiles (TPPs) guide researchers, developers, and manufacturers in creating diagnostic tests that meet essential performance and operational standards. The CDC’s recent call for a Nucleic Acid Amplification Test (NAAT) is a promising step toward advanced testing but lacks crucial specifications for real-world deployment. Recall how our inattention to real-world conditions during the pandemic led to widespread test failures—from NAAT tests degrading in uncontrolled transport temperatures to rapid antigen tests damaged by heat in storage facilities.
We recommend the CDC enhance its NAAT solicitation to include TPP concepts such as:
- Clarifying requirements for operating conditions
- Specifying temperature requirements for transport, storage, and operational stability
- Setting a target cost per test to ensure affordability
- Shifting focus from high-complexity laboratory testing to point-of-care solutions to enhance accessibility and response times
You can find more examples of well-written TPPs in this expanded list with TPP specifications at FindDX.org. In the meantime, even minimal adjustments would eliminate roadblocks that could significantly hinder the utility of CDC test development efforts supported by $148 million in taxpayer dollars.
By embracing these strategies, we can realize:
- Enhanced Surveillance: Unparalleled case detection for all respiratory viruses and earlier identification of H5N1 cases.
- Cost-Effective Solutions: Lowered testing costs to potentially $5 per test through innovative workflows and expansive screening programs.
- Data-Driven Responses: Centralized screening sample collection to enable rapid prioritization and deeper sequencing analysis, allowing us to monitor viral changes and pandemic threats.
Call to Collaboration
I invite like-minded organizations and individuals to join Primary.Health in galvanizing current surveillance efforts by increasing public-private collaborations. Together, we can build on our collective experiences and modernize response capabilities for H5N1. If these ideas resonate with you, let’s partner to make a significant impact and safeguard our communities against H5N1 Email sales@primary.health, call 1-855-970-3223, or contact us.
Let’s collaborate to make a significant impact and safeguard our communities against H5N1.