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QIAGEN (QGEN) Announces COVID-19 Test Updates as Cases Rise

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QIAGEN N.V. (QGEN - Free Report) recently announced two major updates on the COVID-19 testing front. Within Antigen Testing, the company announced its plans to resubmit Emergency Use Authorization application for its QIAreach SARS-CoV-2 Antigen Test to the FDA in the first quarter of 2021. This test claims to detect SARS-CoV-2 antigens in people with active infections in a matter of 15 minutes.

In November 2020, the company had withdrawn the first EUA submission for this test to address a chemistry-related issue.

QIAGEN jointly with Australia-based digital diagnostics company Ellume, developed this QIAreach SARS-CoV-2 Antigen Test. According to QIAGEN, this test, by providing digital results for more than 30 swab samples per hour and with its ability to process antibody tests in parallel, is setting new standards in terms of scalability and flexibility. The company earlier noted this test to be an important step toward decentralized mass screening by processing samples in a short period.

In a parallel press release, the company talked about its polymerase chain reaction (PCR) tests. While global concerns regarding the detection of new viral variants of COVID-19 rising, the company claims that it is closely monitoring the situation and its PCR tests remain accurate and effective in detecting infections.

The company noted that the viral variants have no impact on the effectiveness of its three SARS-CoV-2 PCR tests. In this regard, the company assessed its SARS-CoV-2 PCR tests against genetic mutations of the virus uploaded to the GISAID and GenBank public databases since May 2020. The last assessment was done in January on which the company again reconfirmed the accuracy of QIAGEN assays for detection of SARS-CoV-2 despite all gene mutations.

A Glimpse of Recent COVID-19 Testing Updates

Both in terms of diagnostic tests (molecular and antigen) and antibody tests to detect SARS-CoV-2, diagnostic testing companies have invested billions of dollars so far. Though it was initially assumed that once vaccines are rolled out, the demand for testing will decline, the ongoing resurgence in cases has put the focus back on the testing space.

Given the relentless surge in COVID-19 cases over the past couple of months,Abbott’s (ABT - Free Report) endeavor to complete the supply of 150 million BinaxNOW COVID-19 tests by this week has come as a major respite for the government.

Meanwhile, competing against Abbott’s rapid antigen test, Quidel Corporation (QDEL - Free Report) recently gained EUA for its QuickVue SARS Antigen test. This point-of-care assay for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens, requires no supplemental instrumentation and is visually read. The company was the first to achieve the FDA’s EUA for its rapid antigen test, Sofia 2 SARS Antigen FIA in May.

Again,Becton, Dickinson and Company’s or BD Veritor antigen test is claimed to directly compete with Quidel’s Sofia kit. This rapid antigen test received EUA in July. In terms of molecular diagnostics and antigen tests, Hologic (HOLX - Free Report) has earned a lot of public attention over the past few months. The company generated solid third-quarter revenues from strong customer adoption of Hologic’s SARS-CoV-2 assays that run on the Panther and Panther Fusion systems.

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