FDA Authorizes New High-Throughput, Automated System for Leading COVID-19 Test

Rhea-AI Summary

Thermo Fisher Scientific Inc. (NYSE:TMO) has received Emergency Use Authorization (EUA) from the FDA for its Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit. This system allows laboratories to conduct up to 8,000 PCR tests daily with minimal staffing. The Amplitude Solution combines Thermo Fisher's technologies and is already implemented in labs globally, including Europe and Japan. Although COVID-19 cases are decreasing, demand for routine testing remains, reinforcing the system's relevance. The solution is aimed at scaling testing capacity amidst ongoing pandemic challenges.

Positive

• FDA granted EUA for Amplitude Solution, enhancing testing capacity for COVID-19.
• System can process up to 8,000 samples daily, improving lab efficiency.
• Implemented globally, including in Europe and Japan, showing robust demand.

Negative

• None.

WALTHAM, Mass., April 12, 2021 /PRNewswire/ -- Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit.

Amplitude Solution with TaqPath COVID-19 High-Throughput Combo Kit enables labs to scale high-sensitivity PCR testing

The Amplitude Solution enables clinical and public health laboratories to scale gold standard PCR testing and process up to 8,000 samples in a single day with minimal staffing resources and a secured supply of kits, reagents and consumables to meet their testing needs. The Amplitude Solution has been implemented globally including labs in Europe and Japan.

"While COVID-19 cases globally may be decreasing in some areas as vaccines become more widely available, there continues to be a demand for frequent routine testing to control future outbreaks," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "For population-wide testing programs, lab-based PCR is the best fitting technology, providing confidence in results, capacity to process thousands of samples a day, and consistent, reliable turnaround times. The Amplitude Solution can help support a systematic testing strategy by enabling labs to quickly scale their testing and begin processing high-volume samples, even with limited personnel."

The Amplitude Solution is a molecular diagnostic testing system that helps clinical labs expand testing capacity by combining Thermo Fisher's extraction and real-time PCR instruments with liquid handling products from Tecan Group. The modular system utilizes a high-throughput version of Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, which received EUA in March 2020, to process samples in four steps with minimal hands-on time and laboratory space requirements. The kit's multi-gene target design and updated interpretive software may help labs detect SARS-CoV-2 variants.

For more information on the Amplitude Solution, please visit www.thermofisher.com/amplitude.

Testing with the Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.

The Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit has not been FDA cleared or approved and is only authorized for the duration of the EUA granted under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Media Contact Information: Ron O'Brien	Investor Contact Information: Rafael Tejada
Phone: 781-622-1242	Phone: 781-622-1356
E-mail: ron.obrien@thermofisher.com	E-mail: rafael.tejada@thermofisher.com

 

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SOURCE Thermo Fisher Scientific

FAQ

What is the Amplitude Solution by Thermo Fisher Scientific (TMO)?

The Amplitude Solution is a high-throughput testing system allowing labs to process up to 8,000 COVID-19 samples daily.

When did Thermo Fisher receive FDA authorization for the Amplitude Solution?

Thermo Fisher received Emergency Use Authorization (EUA) for the Amplitude Solution on April 12, 2021.

How does the Amplitude Solution support COVID-19 testing?

The Amplitude Solution combines extraction and PCR technologies to enhance lab testing capacity with minimal staffing.

What are the capabilities of the TaqPath COVID-19 High-Throughput Combo Kit?

The TaqPath Combo Kit can detect SARS-CoV-2 variants and is designed for high-throughput PCR testing.

Is the Amplitude Solution FDA approved?

No, the Amplitude Solution has not been FDA cleared or approved; it is authorized only under the EUA.