Since the earliest days of the COVID-19 pandemic, our Roche team has focused on supporting the global response, doing all we can to ensure healthcare providers and their patients receive the diagnostic tests they need. More than a year and half later, we’ve kept that unwavering focus while also laying groundwork to ensure we’re ready for the next pandemic.
In a recent conversation, Dr. Jamie Phillips, senior scientific affairs manager, and Russell “Rusty” Ring, vice president, government affairs, reflected on how Roche provides what patients need – now and in the future.
Just as the pandemic constantly evolves, Roche is constantly evolving to meet patient needs.
Roche produced the first commercial high-throughput test to identify active infection and support testing demand, followed by a point-of-care rapid molecular test that differentiated flu and COVID-19. “We prioritized the test that differentiates between multiple pathogens on Roche’s high-throughput assay as well,” Phillips said. The Centers for Disease Control (CDC) now recommends these tests over assays that detect SARS-CoV-2 alone. Why? Because multiplex assays save both time and resources.
“Healthcare providers are challenged with differentiating pathogens because they circulate at the same time, and because patients may present similar symptoms,” said Phillips, who has spent years studying coronaviruses and other respiratory pathogens to help launch Roche’s SARS-CoV-2 diagnostic tests. Roche’s all-in-one tests help determine whether a person has coronavirus or influenza (A or B) in one fell swoop.
“By testing for pathogens together in one sample, we’re not missing infections,” Phillips said. “The process also conserves valuable reagents and supplies, which helps everybody.”
Testing has always been an important part of getting back to normal, and the present is no exception. The delta variant, now responsible for 98% of infections in the United States according to the CDC, is fueling outbreaks in areas with low vaccination rates. Vaccinated people, with or without clinical symptoms, pose a risk, too, because they can transmit the virus. That’s a key reason screening is still essential.
High-throughput testing on Roche’s cobas® 6800 and 8800 Systems protects patients and communities by providing quick, high-volume results. The 8800 can produce up to 1,056 results in an eight-hour shift. If a result is needed in minutes at the point of care, the cobas® Liat comes in. “The Roche team brought the high-throughput test to market first due to high demand,” Phillips said. “That demand continues as the delta variant has underscored the value of prevention and screening.”
During the pandemic, Roche hasn’t focused solely on tests that detect pathogens, Phillips said: “We’ve also focused on aiding healthcare providers who care for infected patients.” An example of this is the Elecsys IL-6, which can help clinicians identify COVID-19 patients with severe inflammatory response who need mechanical ventilation.
The healthcare landscape has changed as interventions such as mask wearing have prevented the spread of other pathogens. Respiratory Syncytial Virus (RSV), which can affect people of all ages but causes more severe disease in the young and the elderly, didn’t circulate much last year due to non-pharmaceutical interventions, Phillips explained, but this year, since compliance with mask mandates has decreased, cases are on the rise. This interseasonal increase has prompted the CDC to issue a health advisory recommending that symptomatic patients who are SARS-CoV-2 negative be tested for RSV.
“For the next few years, respiratory season won’t look ‘normal,’” Phillips said. “We plan to be here to help healthcare providers meet their patients’ needs.”
“Roche has been thoughtful about the design of our assays,” Phillips said. “RNA viruses have a high mutation rate. That’s one reason our tests target two regions on the SARS-CoV-2 genome. The virus would have to mutate in two regions for us to miss detection. That could happen, but it’s not likely, as we also design by targeting conserved regions.” A conserved region is a part of the SARS-CoV-2 genome that has the least propensity to change, even if the virus mutates. This dual target feature will help ensure tests are robust and accurate as new variants emerge. Roche also closely monitors variants’ potential impact on test performance.
Public health has long been a focus at Roche, especially since the beginning of the pandemic. Ring, who leads Roche’s government affairs group, said his team’s goal is to promote legislation that ensures hospitals and labs have the support they need to detect diseases and protect patients.
“We’re always looking for ways to find funding for public health labs, small hospitals and physician office labs to help build an infrastructure for testing,” Ring said.
Ring and his team promote policies that give vulnerable populations access to that testing, including point-of-care, polymerase chain reaction (PCR) technology. They also work to place instruments to facilitate high-throughput testing. Said Ring, “For small providers with unmet needs, funding could make all the difference in the world.”
When the pandemic began, the Strategic National Stockpile lacked the resources needed for life-saving care. Ring and his team want to make sure that won’t happen again.
“We’ve spent a lot of time looking at the best way to improve the stockpile and respond to the Pandemic and All Hazards Preparedness Act,” Ring said. “We’ve worked hard to convince leaders to include diagnostics, and in the last year Congress has recognized that during a pandemic, the first thing you have to do is start testing.”
To help meet the need for reliable tests, Roche is investing $500 million globally to increase testing capabilities. “Since the pandemic began, we’ve advocated for the federal government to provide funding to keep our manufacturing lines warm so we could scale up quickly if needed.” Ring said.
Diagnostic testing continues to make a difference as healthcare providers work tirelessly to help patients get the right diagnosis. Roche is committed to meeting those needs.