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Thermo Fisher Scientific

The firm said as part of a development study it is using a gut microbiome analysis tool developed in collaboration with Thermo Fisher Scientific.

Q1 revenues totaled $6.23 billion, up from $6.13 billion in Q1 2019 and beating the consensus analyst estimate of $6.17 billion.

While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.

The PCR-based tests, which detect SARS-CoV-2 nucleic acid, are limited to use in the labs where they were developed, according to the FDA.

Originally developed by Thermo Fisher Scientific, the test is modified for use on additional specimen types, including saliva, as well as with alternative nucleic acid extraction and amplification systems.

The FDA has also granted emergency use authorization for PCR-based tests for SARS-CoV-2 developed by Orig3n, Specialty Diagnostic Laboratories (SDI), and the University of North Carolina (UNC) Medical Center.

The company said that as the COVID-19 pandemic spread throughout the world, it saw a "significant reduction in customer activity" by late March.

The test is designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal and oropharyngeal swab specimens from individuals suspected of having COVID-19.

The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.

Thermo Fisher plans to use the proceeds to pay in part for the acquisition of Qiagen, expected to close in the first half of 2021, and for general corporate purposes.

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New analyses indicate the P.1 variant found in Brazil may be able to infect people who have already had COVID-19, the New York Times reports.

According to CNBC, Novavax's CEO says its vaccine could be authorized in the US as early as May.

The US National Institutes of Health has a new initiative to address structural racism in biomedical research.

In PNAS this week: GWAS of TLV-1-associated myelopathy/tropical spastic paraparesis, analysis of twins with hypertrophic cardiomyopathy, and more.