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More articles about Regulatory News & FDA Approvals

Temple City, California-based Fulgent offers genetic tests for a range of diseases and disorders, as well as custom panels and sequencing services.

The regulatory approval means that the assay for minimal residual disease is available to monitor B cell blood cancers in patients in all 50 states.

NeuMoDx's tests are designed for central laboratory use and run on the company's fully automated NeuMoDx 96 or 288 real-time PCR systems.

Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.

The test is designed to detect clinically relevant pathogens and markers of antibiotic resistance from bronchoalveolar lavage specimens.

The test could potentially enable labs to bring resistance testing in house, rather than send testing out to Canada's National Microbiology Laboratory.

The iC-GN Assay detects target DNA and identifies gram-negative organisms associated with gram-negative bacteremia, and three antibiotic-resistance markers. 

The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.

Forensic laboratories can now use the Applied Biosystems Precision ID System mtDNA analysis to submit profiles to a national database.

The firm said its assay is a real-time qPCR test for the direct detection of methicillin-resistant Staphylococcus aureus DNA in nasal swabs.

The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.

iCubate said that it now has a comprehensive solution within European markets for the detection of bloodstream bacteria and important resistance markers.

Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.

MSK-ACCESS sequences 129 cancer-associated genes selected from the MSK-IMPACT assay and is designed to detect gene alterations in cfDNA specimen.

The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.

The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.

The UK Competition and Markets Authority has announced concerns that the $1.2 billion merger will reduce competition for Illumina and could scrutinize it further.

The firm said that with the approval, the firm's liquid biopsy-based ExoDx Prostate IntelliScore (EPI) test is now available in every state.

Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.

Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.

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In PLOS this week: preconception carrier screening program results, comparative genomics-based analysis of Elizabethkingia meningoseptica, and more.

Canadian regulators are beginning to share information from new drug studies, Undark reports.

In a column at the Dallas Morning News, the Stanley Medical Research Institute's E. Fuller Torrey says the Human Genome Project hasn't delivered on promised results.

Researchers explore a possible genetic cause for some cases of sudden infant death syndrome, KOMO News reports.