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Thermo Fisher’s COVID-19 Test Could Have Inaccurate Results

Article-Thermo Fisher’s COVID-19 Test Could Have Inaccurate Results

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FDA warned earlier this week that Thermo Fisher Scientific’s TaqPath test could have a risk of false results. This follows the Waltham, MA-based company exiting its bid to acquire Qiagen for $12.5 billion.

Thermo Fisher Scientific’s August has been very full so far.

The latest development involves FDA alerting clinical laboratory staff and healthcare providers of a risk of false results with the Waltham, MA-based company’s TaqPath COVID-19 Combo Kit based on two issues related to the test kit and the associated Applied Biosystems COVID-19 Interpretive Software.

The federal agency said this first issue is specifically related to inadequate vortexing and centrifugation of RT-PCR reaction plates. Thermo Fisher Scientific said it has updated its instructions to reduce the risk of inaccurate results.

FDA said the second issue is related to the assay Internal Positive Control (IPC) and requires laboratory staff to upgrade their software to reduce the risk of invalid, potential false negatives, or inconclusive tests and to decrease the potential need to retest.

Thermo Fisher Scientific was granted Emergency Use Authorization for TaqPath in March. FDA said the test has been granted several modifications through supplemental EUA requests between March and July 2020.

TaqPath was granted CE mark in late March.

Thermo Fisher Backs Out of Qiagen Deal

Nearly a week ago, Thermo Fisher Scientific walked away from one of the biggest medtech deals in the pandemic era. (Editor’s note: Teladoc Health’s proposed acquisition of Livongo for $18.5 billion is the largest to date.)

Since November, Thermo Fisher was rumored to be interested in acquiring diagnostic specialist Qiagen. At the time the price was rumored to be for $8 billion. However, after a series of twists and turns, Thermo Fisher made an official proposal of $11.5 billion to acquire Qiagen in March at the beginning of the pandemic.

More layers of complexity were added to the deal when a hedge fund with a stake in Qiagen pushed for a better offer. This then prompted Thermo Fisher to boost its offer by about $1 billion.  The company finally folded on the Qiagen deal last week.

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