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Qiagen NV is set to launch a rapid portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes, the company announced on 8 September.

The portable Access Anti-SARS-CoV-2 antigen test will process up to 32 swab samples per hour using a small digital detection system. Two versions of the antigen test are scheduled for US launch in the fourth quarter – one for labs and one for point-of-care (POC) use. The company said it has applied for emergency use authorization (EUA) from the US Food and Drug Administration and intends to CE mark the test in Europe. 

The POC version could be used in screening settings like airports or stadiums that require a high volume of fast and accurate test results. A positive result would need to be confirmed by PCR. The test is expected to become available in the fourth quarter of 2020 and will rival Abbott’s BinaxNOW COVID-19 Ag Card rapid test. (Also see "FDA Authorizes Abbott’s '$5, 15 Minute' COVID-19 Antigen Test" - Medtech Insight, 27 Aug, 2020.)

“It will deliver highly accurate results and will complement the gold-standard PCR tests used for detection of active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy but are time-consuming and lab-bound,” said Qiagen CEO, Thierry Bernard.

Qiagen said that feasibility tests have shown the Access antigen test to have a sensitivity of at least 90% and a specificity of 100%.

The launch of the test extends Qiagen’s partnership with Australian digital diagnostics company Ellume. The test will run on the Access eHub, a portable digital device that handles up to eight patient samples simultaneously and performs up to 32 total tests per hour, and uses Ellume’s eStick device, which uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein. It is claimed to deliver negative results within 15 minutes.

In August, Qiagen submitted an EUA for its Access Anti-SARS-CoV-2 Total antibody test, which uses the same Ellume devices and said due to demand it has placed a pre-order for 900,000 tests and the first batch of product has been shipped to the US.  

Qiagen has positioned itself as a key player in the COVID-19 testing market. Demand for its portfolio of tests helped boost sales, triggering a shareholder dispute over a planned takeover bid by Thermo Fisher Scientific. (Also see "Hedge Fund Seeks Higher Price For Qiagen As COVID-19 Boosts Sales" - Medtech Insight, 14 Jul, 2020.)

On 13 August, Thermo Fisher Scientific said it had terminated the $11.5bn buyout. Although Thermo Fisher Scientific increased the offer from €39.00 per share in cash to a new price of €43.00, Qiagen shareholders said the price still fell short.  (Also see "Qiagen Terminates Thermo Fisher Deal After Shareholders Reject Last Offer" - Medtech Insight, 13 Aug, 2020.)

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