The coronavirus pandemic has enabled consumers to perform rapid self-tests in the comfort of their homes, a convenient option that test makers like Abbott Laboratories, Becton Dickinson and Quidel are hoping to cash in on with over-the-counter and direct-to-consumer testing for other diseases beyond COVID-19.
The development and adoption of at-home tests that detect coronavirus infection and the integration of digital health technologies are paving the way for broader consumer use of diagnostics for other ailments that don't have to be performed at a hospital, a physician's office or a pharmacy.
Abbott CEO Robert Ford said at last week's J.P. Morgan healthcare conference that the convergence of digital technology and medtech is creating "incredible opportunities to advance healthcare, change healthcare [and] change the way it's delivered."
Ford added that the company is specifically looking to "start to build a more sustainable rapid point-of-care, rapid diagnostic business not only that goes straight to the consumer, but also into other channels outside of the four walls of the hospital."
In the case of Abbott's BinaxNOW COVID-19 rapid antigen test, Ford emphasized that the company "could have done just a simple test, but we also paired it together with our app ... to provide that kind of direct experience where somebody could buy the test and then also get their pass on their phone."
The diagnostics companies are investing in digital health technologies to provide consumers with connected, home-based tests that are meant to support traditional and telehealth providers.
BD said last month that it bought privately held Scanwell Health for an undisclosed amount in order to expand and scale its digital at-home testing. The company previously collaborated with Scanwell to develop the app used with BD's recently launched Veritor home COVID-19 test. The results of tests, which are securely stored in the app, can be accessed by consumers and reported to employers, public health agencies and schools.
While other coronavirus at-home tests use smartphones as part of their testing process, BD contends that its Veritor diagnostic is the first and only test to use a smartphone as the analyzer to digitally interpret the results and provide a definitive positive or negative digital display of results.
"Scanwell will become the foundational digital platform upon which BD plans to develop at-home diagnostic tests for a range of infectious diseases including COVID-19/influenza A+B, group A strep and additional menu for detecting infections and managing chronic disease," the test maker said in last month's announcement.
BD CEO Tom Polen told last week's J.P. Morgan conference that the test maker sees its digital capabilities as a competitive advantage and a key driver for the company's innovation and growth. Polen said BD's recent Scanwell acquisition "advances our focus on enabling new care settings and accelerates smart connected care through smartphone-enabled at-home diagnostic tests."
During Quidel's presentation at the J.P. Morgan conference, CEO Doug Bryant said digital health is "something that we don't talk a great deal about but, nevertheless, we have been spending a great deal of time on it."
Bryant noted that Quidel's integrated digital health and diagnostics products currently are focused on the enterprise and employee health markets. Still, the company is looking for near-term opportunities to expand into the consumer use market beyond COVID-19.
"We have to demonstrate that individuals can collect [specimens] properly and that will be very helpful in clinical trials where we try to demonstrate the sensitivity and specificity necessary to meet the FDA's hurdles for OTC products," the CEO said. "That's very much on the forefront of our minds and is something we're working on."
The goal is to empower consumers to take charge of their own health and wellness by decentralizing testing through investment in digital health, according to Bryant. Quidel is developing a self-test module for cell phones, called QVue, to report results in near real-time.
"A paradigm shift has occurred from the public," Bryant said "Now, with COVID, it has changed the way people think [about self-testing]."
At the same time, Bryant acknowledged that it may be tricky for consumers to perform some tests on their own.
Guided testing and reporting with an authorized telehealth proctor, who can observe the test process, confirm the result and interact with users via video chat, "may be necessary over time for various different uses" and is "potentially something that is necessary in order to have a true over-the-counter product," Bryant said.
When it comes to in-home testing and reporting, Bryant said Quidel has developed a product called SofiaQ that uses the same assay format as the company's professional platform — Sofia/Sofia 2 — with the ability to connect to a cell phone and app for reporting and telemedicine visits.
In the meantime, Quidel is also continuing to invest in third-party partnerships and licensing agreements for technologies and proprietary IP needed to develop new products that will "enable the expanding field of digital health," Bryant said.