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More articles about Regulatory News & FDA Approvals

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.

The Access PCT assay can help clinicians assess patients in danger of severe sepsis or septic shock and delivers results in less than 20 minutes. 

Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.

The reagent is used for the detection of cytokeratin 19 mRNA in surgically removed sentinel lymph nodes in order to diagnose lymph node metastasis.

AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.

The company reported performance changes that led to the product recall and said it is pursuing eventual FDA clearance for the devices.

IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.

CE marking of PromarkerD Hub complements the CE mark that the mass spectrometry version of the test received in November.

The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.

The group wants the agency to allow labs to discuss gene-drug relationships with "adequate evidence" in test reports and hold a public meeting.

The CE mark advances the firm's strategy to develop and commercialize two- to five-minute tests that use fingerprick blood or stool samples, ProciseDx said.

The AlloSeq cfDNA kit is used to quantify the level of donor-derived cell-free DNA in transplant recipients in order to measure graft health.

Luminex got the nod for a qualitative test used to simultaneously detect and identify nucleic acids from respiratory viruses and bacteria.

The firm said its panel, which runs on its MDx-3000 system, tests nasopharyngeal swabs for the most common viruses and bacteria.

The 46-page document advises test makers on how to best implement cybersecurity measures under the new regulation, which is set to go into effect in 2022.

Despite the availability of more precision therapies and complex biomarker tests, systemic gaps and lack of physician education continued to hinder access.

The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.

The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.

BSI will be able to provide conformity assessments to the full scope of the IVDR, which includes more than 80 codes.

The LRT BAL panel detects a wide spectrum of clinically relevant causative agents, such as atypical pathogens and antibiotic resistance markers.

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