The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for the at-home Covid-19 testing kit for children aged three years and above by Eurofins Scientific subsidiary Clinical Enterprise, doing business as empowerDX.
The direct-to-consumer company noted that the polymerase chain reaction (PCR) nasal test is the first-of-its-kind to obtain an EUA for at-home use in children.
In last year’s third quarter, the FDA-authorised empowerDX at-home test was unveiled. The test was indicated for precise detection of the virus in symptomatic and asymptomatic individuals aged 18 years and above.
The company noted that users aged 13 years and above can collect the sample themselves using a painless, shallow nasal swab under adult supervision, while children aged three and above should be assisted by an adult.
The empowerDX at-home test kit comes with instructions, nasal swab, test tube and a pre-paid FedEx package to dispatch the sample for testing.
Test results are provided through a patient portal up to 24 hours after receiving the sample at the company’s lab.
In March, Eurofins launched its upgraded RT-PCR kit, GSD NovaType II, for identifying mutations linked to SARS-CoV-2 variants of concern (VOC).
In another development, Seegene has unveiled an exclusive diagnostic system for detecting Covid-19 variants.
Named ‘Full Screening Solution’, the one-step system can potentially confirm if a person has contracted SARS-CoV-2 wildtype or the variant using a single real-time PCR test.
At present, healthcare specialists are conducting an additional round of genomic sequencing, following standard PCR tests, to detect the presence of Covid-19 variants, which increases the time needed for testing.
Seegene marketing strategy director Dr Guy Willem Lee said: “Seegene’s ‘Full Screening Solution’ will play a critical role in controlling the spread of Covid-19 pandemic amid fast-spreading virus variants.”
In February, Seegene reported that the company’s less-invasive Covid-19 saliva test is as accurate as the nasopharyngeal specimen test, according to a new study.