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The MiQLab system can look for 27 different targets, allowing the detection of SARS-CoV-2 as well as the determination of specific variants.
TruGenX claims that Thermo Fisher's technical support did not resolve testing issues for months, damaging its business and reputation.
The firm's stock price has dropped since the announcement that the agency would need additional information and it has paused test shipments.
The Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit can detect and differentiate RNA from SARS-CoV-2, influenza A, and influenza B viruses.
The test was previously cleared by the FDA for use with ethylenediaminetetraacetic acid plasma samples to manage BK virus in transplant patients.
The researchers also found SARS-CoV-2 neutralizing antibodies in Thai bats and pangolins, suggesting that the progenitor virus may have originated outside of China.
The assay kit also received interim authorization from Health Canada on Jan. 21 and will be used by a large Canadian provincial authority.
The firm expects to increase commercial coverage for its pigmented lesion assay for melanoma while widening its pipeline to diagnose other varieties of skin cancer.
The pace of development for CRISPR-based infectious disease assays increased as the pandemic progressed, more funding became available, and collaboration accelerated.
The two new tests, which have the capability to quantify a patient's viral load, have been designed without external RNA extraction or amplification steps.
Politico reports that the NYPD DNA database has grown since it announced it would be removing profiles from it.
Forbes reports that a structural biology lab at Oxford University studying the coronavirus was hacked.
Science reports that a Dutch research funding agency is combating a ransomware attack.
In Science this week: set of 64 haplotype assemblies from 32 individuals, and more.