Close Menu

NEW YORK ─ Invivoscribe said this week it has received an approval from the US Food and Drug Administration that enables it to distribute its LeukoStrat CDx FLT3 Mutation Assay as an in vitro diagnostic kit in the US.  

This premarket approval (PMA) supplement gives its customers an option to purchase the IVD-labeled LeukoStrat CDx FLT3 Mutation Assay with analysis software for in-house testing, Invivoscribe said.

To read the full story....

...and receive Weekly News bulletins.

Already have a Precision Oncology News or 360Dx or GenomeWeb account?
Login Now.

Don't have a Precision Oncology News or 360Dx or GenomeWeb account?
Register for Free.

Mar
11
Sponsored by
Foundation Medicine

In this session, the third in the Precision Oncology News Virtual Molecular Tumor Board Series, our expert panelists will review patient cases in which genomic profiling has identified gene fusions that may or may not serve as druggable targets.

Mar
23
Sponsored by
Roche

This webinar will discuss findings from the study, in which molecular residual disease (MRD) was assessed using circulating tumor DNA (ctDNA) without prior mutational knowledge in oligometastatic colorectal cancer (CRC) patients who had received neoadjuvant chemotherapy. This study also investigated urine as an alternative analyte for ctDNA MRD detection.

Mar
25
Sponsored by
Foundation Medicine

In this session, the fourth in the Precision Oncology News Virtual Molecular Tumor Board Series, our expert panelists will review patient cases in which genomic profiling identified no clear molecular markers to help guide personalized therapy.

Apr
08
Sponsored by
Roche

This webinar will discuss a single-center prospective interventional study that evaluated the success of a targeted therapy selected by profiling of ctDNA and tissue in patients with advanced and refractory carcinoma.