A handful of rapid 2019-nCoV assays are in the works which could help triage patients more effectively and avoid unnecessary quarantines.
The Centers for Disease Control and Prevention says one of the test reagents will likely need to be remanufactured in its labs.
The EUA allows the test to be used at all CDC-qualified labs in the US on patients who meet CDC criteria for testing for the coronavirus.
The DNBSEQ-T7 ultra-high-throughput sequencer, metagenomic sequencing kit for coronaviruses, and 2019-nCoV RT-qPCR kit have received authorization from China's NMPA.
While it continues to seek investments, the firm is also making preparations for an initial public offering on the Nasdaq First North exchange.
Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.
The firm's EpiSwitch test for blood-based diagnosis of prostate cancer will be evaluated as part of the ongoing PROSTAGRAM trial.
Onkos Molecular Diagnostics is looking for a US partner to commercialize its 11 miRNA-based mir-THYpe test, which it believes offers advantages over tests on the market.
The kit, which was launched today, leverages real-time RT-PCR technology to detect and quantify hepatitis C virus-specific RNA with genotypes 1 to 6.
The firm's new RT-PCR assay identifies 20 gene fusion between NTRK1/2/3 and other genes, allowing clinicians to potentially detect rare forms of different cancers.