Repertoire asked three manufacturers of influenza tests to offer their views on testing for the 2019-2020 season and beyond, and the impact on distributor sales reps. They were:
- Tammi Ranalli, vice president of marketing, North America, Quidel. Quidel offers a continuum of influenza testing solutions from rapid immunoassays to molecular tests: Solana Influenza A+B; Solana RVP (Influenza A+B, and RSV + hMPV); Sofia Influenza A+B for use with Sofia and Sofia 2; and QuickVue Influenza A+B.
- Jonathan C. Overbey, corporate alliances and channel management, Sekisui Diagnostics. Sekisui has three product lines for flu testing: Silaris™ Influenza A&B Test; OSOM Ultra Flu A&B Test; and Acucy, a lateral flow flu test which provides results using a reader.
- Raquel V. Beckett, MBA, U.S. marketing manager, Point of Care, BD Diagnostic Systems. BD offers the BD Veritor™ System and the BD Veritor™ Plus System.
Repertoire: Where are the majority of flu tests being performed today? Do you foresee that changing in the next five years?
Tammi Ranalli: Historically, the majority of flu testing has been performed in doctors’ offices. Primary care practices tend to be the first line of defense for patients of all ages. Today, this behavioral trend hasn’t shifted, with research data showing volume of flu tests performed at doctors’ offices outnumbering those at hospitals by almost two to one (GHX Data Q1 2019).
It’s worthwhile to note the rise of retail clinics and urgent care centers, where the promise of a quick turnaround time and convenience attracts many patients. We anticipate this growth trend will continue in the next five years and beyond, as the busy population demands convenience and speed without sacrificing quality of care. According to industry data, millennials and busy parents are the core demographics utilizing retail clinics and urgent care centers, and we see them driving the growth of this segment.
Jonathan Overbey: As of today the largest share of flu tests are being performed in doctors’ offices and retail clinics. The hospital market tests a lot too, but the larger volume is in the POL/retail space. We expect retail clinics, urgent care clinics and even pharmacies to grow significantly over the next few years, driven by a desire on the part of patients for convenient hours and affordable care.
Flu testing may or may not move to the OTC space, but there will be more CLIA-waived testing available to the patient/consumer in the future.
Raquel V. Beckett: Currently volume is mostly done in doctors’ offices, followed by hospitals, followed by retail and urgent care clinics. We expect retail clinics, urgent care clinics and even pharmacies to grow significantly over the next few years driven by a desire from patients for convenient hours and affordable care
Repertoire: Any thoughts about the upcoming 2019-2020 flu season that might be of particular interest to Repertoire readers and their customers?
Ranalli: For the upcoming flu season, it’s always challenging to predict exactly what the U.S. will see, which is why we enabled our Sofia and Solana platforms with Virena, a HIPAA-compliant patient de-identified infectious disease tracking and data management system that allows our customers to monitor flu outbreaks on both a local and national level.
Overbey: We look at several indicators to try and predict the upcoming flu season. One data point is flu activity in the Southern Hemisphere as they enter the fall/winter season during our summertime. As of [mid-July], the flu season in Australia and New Zealand was very active and strong, which could indicate a strong season for us. We also look at the effectiveness of the year’s flu vaccine. Last year’s flu vaccine was around 30% effective and didn’t address the H3N2 strain, which drove more illness and hence more testing. These two indicators should have us plan on another long and strong flu season in 2019-2020.
Beckett: Monitor flu trends in Australia and Asia, as these tend to be indicators of what we can expect for our flu season in North America.
Repertoire: Your thoughts about the future of flu testing and its impact on Repertoire readers and their customers?
Ranalli: We see healthcare, as a whole, shifting closer to the patient, and flu testing is part of that overall dynamic. Historically, our focus and our strength as a company has been on innovating to serve the needs of patients and healthcare workers in the decentralized, point-of-care segment of the marketplace, so we’re excited about the opportunities there.
Overbey: Flu testing is quickly moving to reader-based and molecular testing methods. The FDA has sent a clear message (i.e., the 2018 flu reclassification) that only the most sensitive and accurate testing methods will remain on the market. Molecular methods are the future because these tests are confirmatory, which means you only have to test one time; there is no need to back up any negative results from other methods.
Beckett: I think we will see a split in flu testing methods by channel. There is significant pressure to provide fast, accurate and reliable testing at reasonable costs with convenient hours for most patients, while those patients requiring extra care with chronic conditions will seek more specialized diagnosis and treatment.
OTC flu tests?
Healthcare providers administer flu tests in physicians offices, retail clinics, even drug stores. Will they ever be available over-the-counter? At least two companies are working on it.
In July 2018, Lucira Health (then named Diassess) reported it was awarded a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary of Preparedness and Response at the U.S. Department of Health and Humans Services. The contract established a partnership to advance development of its flu diagnostic technology for use in physician offices and eventually in consumers’ homes, according to the company.
Emeryville, California-based Lucira says that its flu-diagnostic technologies give a highly accurate diagnosis within 20 minutes. Beginning with a nasal swab, the sample is inserted into a disposable DNA test. The battery-powered device analyzes the sample, and a digital readout indicates either influenza A, B, or a negative diagnosis. The in-home version will use a smartphone application to directly connect the consumer to treatment options, the company said.
Also in July 2018, San Diego-based Cue Health announced it had been awarded up to $30 million in base funding and options from BARDA to accelerate the development and regulatory validation of an over-the-counter and professional use Influenza and Multiplex Respiratory Pathogen diagnostic cartridges for the Cue Health Monitoring System.
The system uses a reader to test clinical samples in a disposable test cartridge and then sends the results to a mobile application. The mobile application is said to provide access to features including interventional components such as telemedicine consultations for consumers and prescribing capabilities for physicians. The Cue Influenza Cartridge will be focused on detecting Influenza A and B. The Cue Multiplex Respiratory Pathogen Cartridge will be a multiplex assay capable of detecting and differentiating between multiple respiratory pathogens.
Attempts by Repertoire to reach Cue Health and Lucira Health were unsuccessful.