Medical Technologies
Catching the Respiratory Illness Season in Australia
The 2023/2024 respiratory season is in full swing, and influenza is back. The U.S. Centers for Disease Control and Prevention (CDC) is currently reporting 6.2% positivity for influenza and the trend appears to be rising. As with previous years, the season is starting along the U.S. southern border and will likely creep north as we approach the new year (Figure 1). As of the writing of this piece, CDC is reporting that Covid-19 positivity is at 10% and RSV is at 13% positivity (Figure 2), and indications are that we may see the peak of the season around the new year. If you are an in vitro diagnostic (IVD) developer, you may be worried you missed the season, but it is not too late. Developers may still be able to catch a portion of the season in the U.S. but can also look to gather data from the Southern Hemisphere, specifically Australia.
Figure 1: CDC 2023-24 Influenza Season Week 7 ending Feb 17, 2024
Figure 2: CDC Percent of Tests Positive for Respiratory Viruses
IVD clinical trials in Australia
Historically, the FDA has allowed test developers to generate data in the Southern Hemisphere once the respiratory season starts winding down in the U.S. and the prevalence of influenza becomes too low to reasonably collect the required samples. The respiratory season in the Southern Hemisphere peaks during the down season in the Northern Hemisphere, giving a prelude to what can be expected in the U.S. in the coming respiratory season. Recently, the agency has also seemed willing to allow influenza B collection in the Southern Hemisphere as well due to the extremely low prevalence in North America. Guidance has been that the FDA will allow up to 30% of samples to be sourced from outside the U.S. or otherwise from non-prospective sources. However, there are limitations to the FDA’s tolerance for data and samples collected in the Southern Hemisphere. For over-the-counter and point-of-care devices, the studies should be executed in a predominately English-speaking country, with similar education, income, and other demographics to the U.S., which makes conducting these trials in Australia extremely attractive.
Conducting trials in Australia comes with its own challenges, but TE Connectivity’s IVD Solutions team is expanding into Australia where it will conduct IVD clinical trials pursuant to Therapeutic Goods Administration (TGA) requirements. With these established relationships in Australia, TE is looking forward to conducting IVD clinical trials in Australia to better support the needs of customers.
