COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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New Jersey Laboratory Sues Thermo Fisher, Alleging Problems With COVID-19 Testing Technology

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Lawsuit alleges test control and software problems that affected clinical laboratories’ ability to perform COVID-19 testing

A New Jersey-based clinical laboratory has filed a lawsuit against Thermo Fisher Scientific, alleging problems with their negative controls and interpretation software. Gene Tox Worldwide, doing business as TruGenX, filed the complaint in the US District Court for the District of New Jersey on Feb. 18, 2021.

TruGenX has claimed that, despite Thermo Fisher’s ongoing technical support, the testing failures they experienced with their equipment have remained an unresolved problem. According to TruGenX’s complaint, this led to “significant financial, operational, professional, and reputational hardship due to [Thermo Fisher Scientific’s] products and services.”

In their complaint, TruGenX cites a public alert to providers and clinical laboratories by the US Food and Drug Administration (FDA) that addressed potential issues with sample processing for the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.

Of note, however, is that this letter was issued in August 2020 and was quickly and thoroughly responded to by Thermo Fisher with software updates and new, in-depth training. TruGenX’s complaint addresses issues that were encountered beginning in September of 2020, after the FDA’s alert had been addressed by Thermo Fisher.

This lawsuit has only recently been filled, and it is important to note that there are still many legal processes that this case must pass through before it becomes evident whether there are any grounds to the allegations being leveled by TruGenX.

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.

Sincerely,

Robert L. Michel
President, Founder
The Dark Intelligence Group