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Thermo Fisher Scientific Sued by New Jersey Lab Over COVID-19 Testing Problems

NEW YORK – Molecular diagnostics lab Gene Tox Worldwide, doing business as TruGenX, has sued Thermo Fisher Scientific, claiming that the firm provided the lab with faulty COVID-19 testing equipment and reagents and didn't adequately help it resolve testing issues for several months.

According to a complaint filed in the US District Court for the District of New Jersey on Thursday, Lyndhurst, New Jersey-based TruGenX has been using Thermo Fisher's 7500 FDx RT-PCR instrumentation, TaqPath COVID-19 Combo kit, and associated interpretive software to conduct COVID-19 testing since the spring of 2020. Starting in September, the lab experienced a number of testing failures related to issues with the negative control and the interpreting software.

TruGenX claims that Thermo Fisher's technical support, despite multiple interactions and visits, did not resolve these issues, and that the problems became worse over time and continued into January 2021.

This, TruGenX wrote, led to "significant financial, operational, professional, and reputational hardship due to [Thermo Fisher Scientific's] products and services," adding that the kit and software were also the subject of a public alert to providers and labs by the US Food and Drug Administration in August 2020 and of a manufacturer recall in September.

TruGenX said it spent "millions of dollars" for Thermo Fisher's products, which it claims were defective, and that Thermo Fisher's conduct has "severely impacted TGX's testing capabilities, business relationships with referring providers, and ability to report valid results to both referring providers and the appropriate public health authorities."

The lab accuses Thermo Fisher of breach of contract, breach of warranty, fraud, and negligent misrepresentation. It asked the court for a jury trial, $1.5 million in damages, including punitive damages, as well as trial costs.

Thermo Fisher Scientific, through a spokesperson, declined to comment on the lawsuit.

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