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Gencurix' RT-PCR-based test detects SARS-CoV-2's Orf1-ab and RdRP genes, while Laihe's assay is designed to detect antibodies against the virus.
The tests are designed to detect regions in the SARS-CoV-2 genome in respiratory samples or antibodies against the virus in human serum, plasma, or blood.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The warning letters may signal increased vigilance from the FDA against firms offering coronavirus antibody tests that it believes could harm consumers.
Applied BioCode's test may be performed by any CLIA-certified lab, while Kaiser Permanente's and Emory's must be run at their developers' labs.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The FDA said that data from the company and an independent evaluation of the test found a higher than expected rate of false results.
The test has 100 percent sensitivity and almost 100 percent specificity, and the company has ramped its manufacturing capacity to deliver 30 million tests per month.
The test has been developed to run on Illumina's NextSeq 550Dx next-generation sequencing platform and will be prepared for commercial launch in Europe.
The PCR test detects HIV-1 RNA on the NeuMoDx 96/288 Molecular Systems and joins the company's other bloodborne viral tests for hepatitis B and C.
The disease occurs when cytomegalovirus infection is passed from a mother to an unborn child and can lead to severe and potentially fatal outcomes.
The PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in various respiratory specimens including nasopharyngeal swabs.
KidneyIntelX can be used to report risk assessment results for fast-progressing kidney disease and future kidney failure for patients with chronic kidney disease.
Cue Health's test is authorized for use at the point of care, while Tide and TBG's PCR-based tests are performed by CLIA-certified laboratories.
Warrior Diagnostics' RT-PCR test detects SARS-CoV-2 RNA in nasopharyngeal swab samples and uses the same primers and probes as the CDC SARS-CoV-2 test.
The test detects SARS-CoV-2 from nasopharyngeal swab specimens and runs on standard qPCR instruments, including Thermo Fisher's Applied Biosystems 7500 Fast machine.
To enable the use of saliva in addition to other types of samples, Sysmex requested a change to a marketing approval it obtained in March.
The firm developed the total antibody test for use on its Dimension analyzers alongside its development for its Advia Centaur and Atellica analyzers.
The tests are designed to detect and differentiate immunoglobulin M and immunoglobulin G antibodies against SARS-CoV-2 in various blood samples.
The company said it has scaled up production capacity to two million reactions per week and has the potential to scale up to three million reactions per week.