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The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.
If approved, the kit would enable automated sample preparation for the company's T-SPOT.TB test using blood samples stored up to 54 hours at room temperature.
The RT-PCR-based test was first authorized in March for the detection of SARS-CoV-2 nucleic acid in specimens collected by a healthcare provider.
The test was first authorized in May for the detection of the SARS-CoV-2 N, E, and ORF1a genes in nasopharyngeal swabs and other specimens.
The Logan, Utah-based company's ELISA-based test is designed to detect immunoglobulin G against SARS-CoV-2 in human serum and plasma.
Though Guardant and Foundation have pioneered a path through the FDA for liquid biopsy tests, label differences highlight complex choices for oncologists.
The saliva collection devices are designed for use with third-party SARS-CoV-2 tests or home/self-collection kits and are not intended for sale to patients.
The point-of-care test runs on the VitaPCR instrument and delivers results in 20 minutes, and has been implemented at Charles De Gaulle airport.
Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
The company's RT-PCR/MALDI-TOF test comprises five assays designed to detect the N, ORF1, and ORF1ab regions of the SARS-CoV-2 genome.
The reissued EUA expands the types of samples that may be used with the Broad Institute's PCR-based SARS-CoV-2 test, which was first authorized in July.
Ortho said its antigen test offers 98.9 percent concordance to real-time PCR tests, making it a viable alternative for mass-scale testing during the pandemic.
FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer.
The test can be used with the Liaison XL, Liaison XS, and Liaison analyzers. More than 8,000 such systems are installed in laboratories worldwide.
The firm said that its antibody tests detect the presence or absence COVID-19 antibodies and measure their levels.
The test analyzes substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, along with some genomic signatures in solid tumors.
The reissued Emergency Use Authorization from the US Food and Drug Administration also permits the test's use in asymptomatic individuals, the firm said.
The test confirms the presence of antibodies directed to various gene products of HIV-1 and HIV-2 in human serum or plasma.
Wren Laboratories and P23 Labs received revised EUAs that allow their previously authorized tests to now be used with new specimen types.
The product, which received the CE mark earlier this year, uses digital imaging and AI to automate peripheral blood smear analysis.