FDA Clears DASH SARS-CoV-2, Flu A/B Combination Test
Using the DASH Rapid PCR System, providers can yield test results in under 1 minute of hands-on time.
Nuclein’s DASH SARS-CoV-2 and Flu A/B test has received 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA. According to a news release from the company, the 3-in-1 test will provide patients with COVID-19, influenza A, and influenza B results in a single visit lasting no longer than 15 minutes.1
“Nuclein was founded with a vision to enable simple, affordable, rapid, and accurate testing for everyone,” Nuclein CEO Alan Blake said in a release.1 “FDA 510(k) clearance and a CLIA waiver for the first of many anticipated tests for our DASH Rapid PCR System marks an exciting step towards realizing this vision.”
Providers can receive test results in under 1 minute of hands-on time. | image credit: Estanis BS / stock.adobe.com
With more promised to come down the pipeline from Nuclein, it’s the company’s DASH Rapid PCR System technology that is revolutionizing the diagnostics industry. The technology’s A/B test is designed to offer patients and providers highly sensitive and specific results for COVID-19 and the flu at a lower cost.
READ MORE: FDA Approves Tirzepatide for Obstructive Sleep Apnea in Patients with Obesity
When it comes to expanding the DASH Rapid PCR System technology, Nuclein has vouched to explore other areas of diagnostics and expand its testing menu. The manufacturer has promised to introduce its new technology into other respiratory diseases and sexually transmitted infections, among others. However, before looking to the future of Nuclein’s technological advancements, its 510(k) clearance and CLIA waiver came at an opportune time.
“[COVID-19] levels were nearly the lowest they’ve ever been through October and all of November. Trends started to shift in early December, though, with levels rising from low to high by the middle of the month,” wrote Deidre McPhillips for CNN.2“In the week ending December 21, there was nearly 3 times as much COVID-19 circulating in the US than there was during the week ending December 7.”
With record-low October and November trends moving higher in December 2024, the expected winter surge in COVID-19 cases is taking shape. From December 14 to December 21, the weekly percentage of test positivity in the US increased from 5.5% to 7%, according to CDC data.3
Experts are owing the rise in cases to what they are calling the “newly dominant” XEC COVID-19 variant.2
“As of December 9, 2024, there were 13,331 XEC sequences submitted to GISAID from 50 countries, representing 36.8% of the globally available sequences in epidemiological week 47 (November 18 to 24, 2024). This is a significant rise in prevalence from 26.9% 4 weeks prior in epidemiological week 44 (October 28 to November 3, 2024),” wrote the World Health Organization.4
WHO claims that the XEC variant poses a low public health risk globally. However, it is the only SARS-CoV-2 variant that has shown a significant prevalence in all 3 WHO regions: the West Pacific region, European region, and the Americas region.
With a high prevalence but low public health risk, tools like the DASH Rapid PCR System can provide life-saving data if the XEC variant continues to increase in prevalence.
From an easy-to-use nasal swab for patients while testing, to integrated cloud connectivity with providers’ health systems, the new technology is promised to be seamlessly incorporated into urgent care locations, physician offices, pharmacies, emergency rooms, and more.1
Nuclein said in the release that the DASH Rapid PCR System and DASH SARS-CoV-2 & Flu A/B test will be available later this month.
READ MORE: Infectious Disease Resource Center
Are you ready to elevate your pharmacy practice? Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.
