How does medical purpose drive regulatory requirements in EU clinical trials?
Clear and accurate assessment of whether use of an assay in a clinical trial assay is considered exploratory or an “IVD” is necessary as implications extend to quality/regulatory pathways, assay de
Taking Spatial Toward the Clinic: DeciBio’s Q&A with Sandy Au of NeoGenomics
Blog originally posted on Decibio Insights here.
Is IHC going to exhaust our archival blocks the way single gene testing used to?
Over the past year we have seen unprecedented demand for IHC assay development services with the goal of creating a prototype CDx assay.
Orphan CDx assays
Drug development is rapidly outpacing our ability to bring companion diagnostics to market.
First CDx Approval for HLA Typing
We have seen HLA typing become more prominent in oncology clinical studies. Especially in the realm of immuno-oncology therapeutics including CAR T-cells, bi-specifics, and cancer vaccines.
ISO 15189 accreditation of the Swiss and Singapore NeoGenomics sites
In 2020 NeoGenomics decided to launch an accreditation program for its international sites in Switzerland and Singapore.
Perspectives on a ssPMA CDx submission
The proprietary, high sensitivity Sanger sequencing assay (LOD <1%), developed by NeoGenomics, was used in certain BeiGene Phase 2 and Phase 3 clinical studies to determine the MYD88 status of p
Talking Cancer: Conversations with Trailblazers, Advocates, Patients, and Medical Ambassadors
In the middle of the pandemic, GO2 Foundation for Lung Cancer appointed Dr. Jennifer King as their Chief Scientific Officer in May 2020.