New care settings and innovation will usher diagnostic testing into the future

April 24, 2023

The 1918 influenza pandemic went down in history as a plight of epic proportions, taking the lives of an estimated 675,000 people in the United States alone, according to the Centers of Disease Control and Prevention (CDC).1 And so, it is sobering to realize that deaths from COVID-19 in the United States surpassed 1.1 million in January 2023.2 With new variants and subvariants constantly emerging, the hopes for near-term eradication of the disease have diminished. Yet even as some organizations and governments are ready to classify COVID-19 as endemic, it will be with us for the foreseeable future.

In 2019, just like in 1918, people were unprepared for the devastating impact that would lay ahead. There were no definitive diagnostics, treatments, or vaccines. Today, thankfully, we have vaccines, testing, tracking, tracing, and treatments available for both the flu and COVID-19, but the processes of tracking and treating — and therefore, of potentially saving lives — begins with testing.

Diagnosing respiratory viruses

Prior to the COVID-19 pandemic, if a person developed a cough, our initial thought was, “Is it a cold or is it the flu?” In children, we may also ask “Is it RSV?” since nearly all children before the age of two are diagnosed with the disease.3 When COVID-19 hit and lockdowns were put in place, our risk for becoming infected with any of these viruses was limited. However, as we lifted restrictions and returned to a state of normalcy, flu, RSV, and COVID-19 received an open invitation to spread. While fears of a “tripledemic” this respiratory season have largely diminished, testing remains a critical tool that healthcare providers rely on to ensure accurate diagnosis and treatment for their patients.

In fact, about 70% of all medical decisions are based on diagnostic test results.4 To aid medical professionals in diagnostic testing, there are now combination tests available that work by testing a single sample from a patient for multiple respiratory diseases, such as COVID-19 and seasonal flu, which can show similar symptoms. A recently developed combination test can detect COVID-19, the flu, and/or RSV from one nasal sample. The test was recently authorized for emergency use by the U.S. Food and Drug Administration (FDA) for testing by authorized laboratories.5

At-home diagnosis

With the delivery model of healthcare having been reinvented over the past few years and accelerated because of the COVID-19 pandemic, there have been major opportunities for the industry to improve access to healthcare, improve patient outcomes, and reduce costs all around. Today, tests for flu or COVID-19 can be conducted at local pharmacies and individual’s homes. Soon, a wide range of diagnostics will be available for use in these new care settings, as will easier and less invasive ways of doing so. These advanced technologies increase accessibility and allow patients to take more control of their health by helping them prevent, monitor, and manage disease — not just react to health emergencies.

In addition to at-home care, new technologies are enabling digitally integrated diagnostics. Making care even more accessible to patients, the electronic transmission of results to patients and providers will enable earlier intervention in the progression of disease. Data analytics from at-home tests will be another area of transformation. Researchers will have better tools and data sets to pioneer breakthroughs, including diagnostics, devices, and other technologies.

At-home tests are a profound transformation that will increase access to testing and allow patients to take more control of their health. To this end, we envision a future where more testing solutions will be made available in new care settings, as well as at-home tests to monitor and help manage chronic disease conditions. At-home testing and self-sampling is not just convenient, it also provides greater access to diagnosis of potentially deadly diseases, like cervical cancer. Some countries in Europe and many other parts of the world offer self-sampling for cervical cancer screening with a Pap or HPV test, giving women the ability to collect their own sample for lab-testing in privacy, at the time and place of their choosing.

Conclusion

We are entering a world where every lab test, doctor’s visit, injection, procedure, and implant will be supported by advances in artificial intelligence, machine learning, and connectivity. Digital tools will equip providers to make better-informed decisions, faster — enhancing care for patients. This means earlier diagnosis, easier medication management, and more proactive care interventions.

Smart, connected care in new care settings to diagnose and manage disease is not only the future of healthcare, it is already here. 

REFERENCES

1.    History of 1918 flu pandemic. Cdc.gov. Published January 22, 2019. Accessed February 15, 2023. https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/1918-pandemic-history.htm.

2.     NVSS - provisional death counts for COVID-19 - executive summary. Cdc.gov. Published August 8, 2022. Accessed February 15, 2023. https://www.cdc.gov/nchs/covid19/mortality-overview.htm.

3.    Respiratory Syncytial Virus (RSV). Viaid.nih.gov. Published July 22. Accessed February 23, 2022. https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv.

4.    Strengthening clinical laboratories. Cdc.gov. Published November 15, 2018. Accessed February 15, 2023. https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html.

5.     BD receives FDA emergency use authorization for COVID-19, influenza A/B, RSV combination Test. BD Newsroom. Accessed February 15, 2023. https://news.bd.com/2023-02-08-BD-Receives-FDA-Emergency-Use-Authorization-for-COVID-19,-Influenza-A-B,-RSV-Combination-Test.