Andrew P. Han

Sep 12, 2024 | precisionmedicineonline.com | Andrew P. Han

NEW YORK – Memorial Sloan Kettering Cancer Center (MSK) is in the process of implementing a new rapid sequencing-based cancer panel to complement ongoing comprehensive genomic profiling (CGP). The assay, branded as MSK-React, is based on a new panel from Pillar Biosciences, recently launched as the OncoReveal Nexus. MSK-React masks two of the 21 genes in the panel and is available in separate reported formats for solid and hematological tumors.

Dec 18, 2023 | 360dx.com | Andrew P. Han

NEW YORK – Illumina said on Monday that it plans to divest Grail by June 2024 in either a third-party sale or a capital markets transaction. The announcement comes after the US Court of Appeals for the Fifth Circuit issued a decision on Friday that sidestepped Illumina's grandest arguments about why the US Federal Trade Commission erred in April when it ordered Illumina to sell off the multi-cancer early detection test company it bought in 2021 for approximately $8 billion.

Nov 17, 2023 | 360dx.com | Andrew P. Han

SALT LAKE CITY – The Association for Molecular Pathology has asked Congress to revisit the idea of updating the Clinical Laboratory Improvement Amendments (CLIA) as an alternative to a recently proposed rule by the US Food and Drug Administration that would regulate laboratory-developed tests as medical devices. Nevertheless, the organization is bracing for the FDA to push through the rule and is preparing legal action to challenge the agency.

Nov 17, 2023 | 360dx.com | Andrew P. Han

SALT LAKE CITY – Roche has presented data on the concordance of its Avenio Tumor Tissue comprehensive genomic profiling (CGP) assay with alternative products from its Foundation Medicine subsidiary and Illumina.  In a sponsored session Wednesday at this year's annual meeting of the Association for Molecular Pathology, Roche Diagnostics Solutions Medical Affairs Lead Helle Sorensen shared data from studies comparing Avenio with the FoundationOne CDx and Illumina's TruSight Oncology (TSO) 500.

Oct 19, 2023 | 360dx.com | Andrew P. Han

NEW YORK – Children's Mercy Hospital has created a new laboratory-developed test based on long-read sequencing, which it says could reduce the number of tests needed to diagnose critically ill newborns. The recently validated test uses so-called "five-base" HiFi sequencing from Pacific Biosciences which provides methylation calls in addition to long reads.