The skin cancer diagnostics company said it delivered 5 percent fewer DecisionDx-Melanoma test results in Q4 2020 than in the previous year's fourth quarter.
The assay from San Diego-based Cue is the first molecular test authorized by the US Food and Drug Administration for home use without a doctor's prescription.
The company also said that a previously granted EUA for its Alinity m SARS-CoV-2 assay has been expanded to include asymptomatic individuals and pooled testing.
R-Pharm, Illumina's strategic partner in Russia and the Commonwealth of Independent States (CIS), led the registration process with the Russian regulatory agency.
The firm said its T-cell test complements serology testing and provides a more comprehensive view of the adaptive immune response to SARS-CoV-2 infection.
Based on full approval from the FDA based on the Phase III CROWN trial, Pfizer can now market the drug as a front-line option for ALK-positive NSCLC patients.
The test is designed to assess the risk of a person developing severe disease if they contract COVID-19 based on a combination of genetic and clinical factors.
The firm said that with the addition of a target for SARS-CoV-2, its high-throughput NxTag syndromic respiratory panel includes 19 viral and two bacterial targets.
The company is using the funds to develop a blood-based test that uses infrared spectroscopy and artificial intelligence for early-stage cancer detection.
Michael and Regan Dube will pay a total of $9,015,046, plus interest as a result of their convictions. Regan Dube was previously sentenced in November.
QiaCube Connect MDx is designed specifically for IVD applications, and automates DNA, RNA, and protein sample processing using Qiagen spin column technology.
