COVID’s impact lingers.
Respiratory season always comes with many questions and a few surprises. The 2022-2023 season promises to be no exception.
For starters, the effects of COVID-19 will linger. In May the Centers for Disease Control and Prevention reported that one in five COVID-19 survivors aged 18–64 years and one in four survivors aged 65 and older experienced at least one condition that might be attributable to previous COVID-19 four weeks or longer after experiencing acute symptoms. Among all ages, the highest risks in the study were for acute pulmonary embolism and respiratory symptoms.
The 2022-2023 season may deal some wild cards as well, like avian influenza (HPAI) Asian (H5N1). Sporadic human infections with HPAI Asian H5N1 virus resulting from direct or close contact with infected sick or dead poultry are expected to continue to occur, and some of those cases will likely be fatal, according to CDC. Person-to-person transmission has been very rare, but should the virus recombine with human influenza A viruses, an influenza pandemic could result.
“The biggest challenge reps will face is how to offer customers sound advice in an ever-changing market,” says Cisco Merrill, senior director of sales, alternate sites and channels, Cepheid. “They are often viewed as the product expert and trusted consultant to their customers, but with state-by-state regulations changing, Americans facing COVID fatigue and our country working through the dynamics of re-opening safely, managing a complex economy, high inflation, etc., it can be a burden to offer solutions that provide the best patient care but help them keep their practice doors open.
“The most successful reps tend to understand their customer’s needs the best, and then partner with the appropriate manufacturers and solutions that allow them to best meet those needs.”
Precarious position
“While daily case rates have significantly declined since the Omicron surge, several COVID-19 mitigation measures (i.e. mask-wearing and social distancing) have been lifted and are no longer being enforced,” says Chris Girard, U.S. product manager, point of care, BD IDS. “These mitigation measures were critical in limiting viral transmission during last year’s respiratory season.
“During the hot summer months, people spend more time outdoors, which allows less opportunity for viral respiratory transmission. However, during the cooler winter months, people tend to congregate indoors, which allows respiratory viruses like COVID and the flu greater opportunity to spread from person to person. If we are not masking up and socially distancing like we were last respiratory season, the expectation is that we will be in a much more precarious position for viral transmission of COVID, flu, and other viruses that cause the common cold this respiratory season. For these reasons, having access to combined COVID and influenza in-office diagnostics will be important for medical providers to distinguish between the overlapping symptoms present in these conditions.”
Commenting in mid-June, Girard pointed out that several countries in the Southern Hemisphere such as Australia were reporting the worst flu season in years. The Department of Health showed Australia had recorded more than 38,000 flu cases. About 70% of those cases (more than 26,000) were reported in just a two-week period from May 9-22.
“This significant spike in influenza cases can likely be attributed to the global relaxation of mitigation measures for COVID-19,” he said. “Based on the current public health data being reported in the Southern Hemisphere, we can expect a significant increase in influenza prevalence and transmission in the United States during this upcoming respiratory season.”
More susceptibility than usual
“Much will depend on whether COVID-19 surges again mid-fall or early winter,” says Mike Abney, senior vice president, North American sales and distribution, Quidel. “If it does not surge, then we are poised for a more prominent, perhaps even moderate to severe influenza season. Without the COVID-19 surge, people will be even less inclined to exercise [non-pharmaceutical intervention], mask-wearing, etc. than they are now – and they will be more likely to catch a respiratory disease.
“With the greatly reduced incidence of influenza in the last two ‘seasons,’ the population’s herd immunity is likely down, making our citizens even more susceptible than usual – and making the high-risk people even more at risk,” he says. “The presumed viral interference exerted by SARS-CoV-2 could be absent, also opening the door for more rapidly spreading influenza.
“Interestingly, there has been influenza this winter and spring and it is almost purely influenza type A. The herd immunity versus type B, therefore, might decline even more than that vs. type A. We should expect, if COVID-19 declines, to see potentially a more prominent surge of influenza B than usual.”
A significant respiratory season
Jonathan Overbey, head of corporate alliances and channel management, Sekisui Diagnostics, says that as more physicians test for COVID and get back negative results, they are once again testing for flu and other respiratory conditions, such as strep, mono and RSV. “As we know, these didn’t go away during the pandemic; they just didn’t get tested [as patients] avoided the doctor’s office,” he says. “We expect a strong flu season this year, but that could change if another variant impacts testing. It appears people are moving on and living with COVID-like endemic viruses, and we have suppressed our immune systems over the last two years.
“If there is not another super contagious variant breakout and possible shutdown of in-person school and in-person activities, it should be a significant respiratory season. Reps should discuss all these options now with their accounts to ensure they have ALL of the respiratory test kits on hand.”
Expect the unexpected
Cisco Merrill of Cepheid suggests the country prepare for the unexpected. “Respiratory seasonality is no longer a set time of the year. You used to be able to set a calendar as to when customers would start to pre-book flu. Cases would spike as children started back to school and would dip in late spring as the weather turned warm. That is no longer the case.
“Positive flu cases were still being reported in June, RSV cases spiked across the country in higher numbers than we have seen in years, COVID cases are again on the rise, and Omicron has mutated more and lasted longer than all its predecessors,” he says. “So as the summer months begin to wind down, kids head back to school and the weather turns cool, who knows what will be thrown our way? One constant is that if you put your customers’ and patients’ needs first, by providing the sound guidance and solutions that aid them in impacting better outcomes, you will always put them in a position to be successful as well as yourself.”
An element of unpredictability
In response to Repertoire’s questions, an Abbott spokesperson says, “Our most recent respiratory seasons have shown an element of unpredictability that is historically uncommon for respiratory season. Customers must now consider potential COVID-19 variants, its impact to future waves, unknown levels of other respiratory viruses and labor shortages. “Preparedness has never been as important as it is today. Distributors will play a key role this upcoming respiratory season to help customers proactively plan their rapid testing needs to provide quick and accurate answers to their patients.”
Sidebar:
Respiratory season Q&As
Repertoire submitted questions to vendors about their respiratory-related diagnostics products. Here are their responses.
BD-Integrated Diagnostic Solutions
Q: Have you made any changes to your line of respiratory diagnostic products that Repertoire readers should be aware of? If so, can you explain them?
A: We are continuing to strive to make testing easy, accessible, and affordable. Our combined COVID-19 & Flu A+B test leads the way here with a simple, single-sample test with clear results in 15 minutes. The test is also able to detect a co-infection with COVID-19 and influenza. We are continuing to offer promotional bundles as well that cover the capital cost of the analyzer so that customers are only paying for the tests they use. And we know that the pandemic continues to be unpredictable, so we are not requiring any contract commitments from customers to still receive great pricing and value from our systems.
Q: What sales challenges can Repertoire readers expect to face this respiratory season insofar as in-office diagnostics are concerned? How will successful reps overcome those challenges?
A: During respiratory season, there is increased prevalence and co-circulation of several viruses and conditions that present with overlapping symptoms. These viruses and conditions include (but are not limited to): influenza, COVID-19, seasonal allergies, group A strep, RSV, and other viruses that cause the common cold (adenovirus, rhinoviruses, and other coronaviruses, etc.). All these conditions present with common upper respiratory symptoms such as cough, sneezing, sore throat, and runny nose, making it incredibly difficult for providers to accurately assess, diagnose and treat a patient’s symptoms off clinical presentation alone.
For these reasons, having access to combined COVID and influenza in-office diagnostics will be important for medical providers to distinguish between the overlapping symptoms present in these conditions. Furthermore, we now have FDA-authorized and approved treatments for COVID and influenza, so having tests that can differentiate between each virus will be critical to successfully implement the Biden Administration’s “Test to Treat” initiative.
Q: Last fall Repertoire reported that BD received Emergency Use Authorization (EUA) in February and March 2021 for the BD® SARS-CoV-2/Flu assay, which is run on the BD MAX™ System; and the BD Veritor™ System for Rapid Detection of SARS Co-V-2 & Flu A+B test. Any updates?
A: BD has partnered with ImageMover MD, a result management and workflow services organization that helps customers intake patients, digitally store results, and automatically share results with the patient and state/federal health departments. This result management system is available at no-charge to BD Veritor™ customers and works with all BD Veritor™ assays. To learn more, email: BDVeritorOrder@imagemovermd.com
Quidel
Q: Have you made any changes to your line of respiratory diagnostic products that Repertoire readers should be aware of?
A: Quidel offers a full suite of respiratory diagnostic testing from visual read to high throughput molecular. All of our products are readily available, manufactured domestically, and are supported by a vast commercial organization including our territory account managers, strategic account managers, channel sales directors and various product sales specialists.
Q: What sales challenges can Repertoire readers expect to face this respiratory season insofar as in-office diagnostics are concerned? How will successful reps overcome those challenges?
A: Challenges for distributors in the upcoming season could include the volatility of COVID surges as well as increases of flu, Strep A, and RSV during what would typically be deemed as offseason. Given the uncertainty, clinicians must be ready to provide accurate and fast testing at a moment’s notice. It is imperative for a distributor sales representative to stay closely connected with both end user customers as well as manufacturing partners to be able to recommend a tailored solution for each customer and to share which products are readily available. It is important to follow real-time trends of various disease states in respective geographies including the CDC map and also Quidel’s virena mapping at: https//beinformed.quidel. com/, says Abney.
Q: Last fall Repertoire reported that in October 2020, Quidel received EUA to market the Sofia® 2 Flu + SARS Antigen FIA, to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer. Any update?
A: Yes. Three developments:
- In December 2020, Quidel received EUA to market the QuickVue SARS Antigen Test, to be used in traditional healthcare spaces.
- In March 2021, Quidel received EUA to market the QuickVue At-Home COVID-19 Test, a visually read diagnostic for COVID-19 to be used at home or in the workplace.
- In May 2022, Quidel received EUA to market the Solana SARS-CoV-2 Assay, an updated and easier to use version of our HDA molecular assay.
Sekisui Diagnostics
Q: Have you made any changes to your line of respiratory diagnostic products that Repertoire readers – i.e., distributor sales reps – should be aware of? If so, can you explain them?
A: Yes! We are hoping for FDA EUA authorization for three COVID tests soon. We will then launch through our distribution partners a COVID Antigen test on our Acucy reader as well as a lateral flow antigen test under our OSOM brand and a combo Flu and COVID test too.
Q: What sales challenges can Repertoire readers expect to face this respiratory season insofar as in-office diagnostics are concerned? How will successful reps overcome those challenges?
A: The biggest challenges remain to some degree, with supply chain issues and rolling backorders for PPE and some other materials. Reps continue to work hard and advocate for their customers. With diagnostics, they need to manage their accounts that testing is needed for more than just COVID, and they need to bring in other respiratory kits despite any short-dated COVID tests they have on hand, etc. Testing is the best way to control the spread of any respiratory issue and that includes testing for all things to “rule in” or “rule out” a diagnosis.
Q: Last fall Repertoire reported that in March 2020, Mesa Biotech received an EUA for the AcculaTM SARS-Co-V-2 test, which is distributed by SEKISUI Diagnostics. Any update?
A: In February 2021, ThermoFisher acquired Mesa Biotech and has taken over all commercial sales and operations for all of Mesa Biotech product lines. Sekisui Diagnostics is no longer a distributor of Accula.
Cepheid
Q: Have you made any changes to your line of respiratory diagnostic products that Repertoire readers should be aware of? If so, can you explain them?
A: From a preparations standpoint there is no difference in how we are treating 2021 versus 2022. We are going to produce and deliver as much respiratory product to the market as we can make. Our production levels have increased quarter over quarter since the start of the pandemic, and we intend to deliver our Xpert® Xpress CoV-2 plus and Xpert® Xpress CoV-2/Flu/RSV plus assays to our ever-expanding customer base. One change, due to our increasing production capabilities, is that we will be offering both of our respiratory offerings (Covid Plus & 4-Plex Plus), as we are at production levels that afford us the ability to offer our customers both products this respiratory season.
Q: Last fall Repertoire reported that in September 2020, Cepheid received EUA for Xpert® Xpress SARS-CoV-2/Flu/RSV for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. Any updates?
A: In September 2021, we received EUA Authorization for our Xpert Xpress CoV-2/Flu/RSV plus, improving on the already stellar existing Xpert Xpress SARS-CoV-2/Flu/RSV product. Key enhancements include the addition of a 3rd gene target for SARS-CoV-2 (RdRP now included in addition to E and N2), to be more robust against mutations, to include the addition of eNAT for anterior nasal and nasopharyngeal swabs, which mitigates the need to use a hood when transferring patient samples, as the eNAT solution neutralizes the active COVID sample. Additionally, the former test would provide a positive result within 46 minutes. The new COVID Plus assay, provides a positive result within 20 minutes.