Flowflex News & Product Updates

ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants. The Omicron variant of concern remains the dominant variant circulating globally, accounting for nearly all sequences submitted to GISAID. Among the Omicron variant, BA.2.12.1, BA.4, and BA.5 represent the highest proportion of circulating variants. Testing conducted by a third-party laboratory between May and July 2022 has indicated that the Flowflex™  COVID-19 Antigen Home Test does detect Omicron BA.2.12.1, BA.4, and BA.5 in patient specimens. ACON will continue to monitor the evolution of SARS-CoV-2 variants in circulation worldwide and evaluate the performance of our assays against future variants to maintain the high level of product performance our customers have come to rely upon. If you have questions, please contact

We at ACON Laboratories, Inc. have been continuously monitoring the emergence of COVID-19 variants. The Omicron variant (B.1.1.529) is currently the dominant variant circulating globally, accounting fornearly all sequences reported to GISAID. Omicron is made up of several sub-lineages, the most common ones are subvariant BA.1 and BA.2. An independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex™ COVID-19 Antigen Home Test does detect the Omicron subvariant BA.1 and BA.2 in live clinical samples. ACON will continue to monitor the evolution of COVID-19 variants in circulation worldwide and evaluate the performance of our assays against future variants to maintain the high level of product performance our customers have come to rely upon. Sincerely, Michael

SAN DIEGO, CA, January 9, 2022 – ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” ACON Laboratories is not importing the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” into the U.S. as it is only authorized for sale in Europe and other markets, under the CE mark. This press release serves as public announcement that this CE marked product is being recalled from the U.S. market. The “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” cannot be legally imported, distributed, or used in the U.S. market as it has

ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants, including the Omicron variant. We are pleased to report that an independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex™ COVID-19 Antigen Home Test does detect the Omicron variant in live clinical samples. ACON will continue to monitor the evolution of COVID-19 variants in circulation worldwide and evaluate the performance of our assays against future variants to maintain the high level of product performance our customers have come to rely upon.

We at ACON Laboratories, Inc. have been continuously monitoring the emergence of SARS-CoV-2 variants and the Omicron variant is no exception. The Omicron variant is notable for the significant number of mutations in the Spike protein. Those mutations are not relevant to the Flowflex™ COVID-19 Antigen Home Test, which detects the SARS-CoV-2 Nucleocapsid protein. According to the GISAID analysis and the pairwise sequence alignment comparison of the Nucleocapsid protein from all of the tested variants (B.1.351, B.1.1.7, P.1, and Delta variant B.1.617.2), there is a high likelihood that the SARS-CoV-2 Omicron Variant (lineage B.1.1.529) is detectable by the Flowflex COVID-19 Antigen Home Test. We anticipate testing virus samples, once they become available to us, to further verify the performance of

SAN DIEGO, CA., October 4, 2021 – ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced today that its Flowflex™ COVID-19 Antigen Home Test has been authorized for emergency use by the U.S. Food and Drug Administration. The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test which will soon be available for purchase without a prescription in major retail stores and online. It may be used for self-testing by individuals aged 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old. In contrast to other home tests which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home