NHS England will wait to consider NHS rollout of Galleri multi-cancer early detection test

Pooled analysis questions reliability of an endpoint used in multi-cancer detection trials

An analysis by researchers from the International Agency for Research on Cancer casts doubt on validity of an endpoint used in key studies of multi-cancer detection tests.

NCI launches research network to evaluate emerging cancer screening technologies

NCI has launched a clinical trials network to evaluate emerging technologies for cancer screening. The Cancer Screening Research Network will support the Biden-Harris administration’s Cancer Moonshot by investigating how to identify cancers earlier.

February 23, 2024

Vol.50 No.08

Regulatory News

Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approval
Meanwhile, NCI trial will assess clinical utility

Multi-cancer detection tests evoke conflicting reactions—the excitement at their promise is quickly dampened by concerns over the uncertainty of their clinical benefit, very low sensitivity for detecting stage 1 cancers, and the risks that come from subsequent workups.

Crapo, Bennet, Cardin, and Scott introduce legislation to expand coverage of MCEDs

On June 22, Sens. Mike Crapo (R-ID), Michael Bennet (D-CO), Ben Cardin (D-MD), and Tim Scott (R-SC) introduced the Medicare Multi-Cancer Early Detection Screening Coverage Act, which would grant Medicare the authority to cover multi-cancer early detection tests once they are approved by FDA.

July 07, 2023

Vol.49 No.27

Clinical Roundup

GRAIL presents PATHFINDER multi-cancer early detection screening study results

GRAIL LLC presented final results from the interventional PATHFINDER study, which evaluated multi-cancer early detection screening using a blood test and the clinical care pathways following a “cancer signal detected” MCED test result in 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer.

September 16, 2022

Vol.48 No.33

Fate of Illumina-GRAIL $7.1B merger uncertain as (1) EU blocks it, (2) FTC administrative law judge jettisons agency’s opposition

European regulators have prohibited the already-implemented $7.1 billion merger of Illumina and GRAIL, stating that the deal “would have stifled innovation, and reduced choice in the emerging market for blood-based early cancer detection tests.”

September 09, 2022

Vol.48 No.32

By Paul Goldberg

NHS England will wait to consider NHS rollout of Galleri multi-cancer early detection test

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Pooled analysis questions reliability of an endpoint used in multi-cancer detection trials

NCI launches research network to evaluate emerging cancer screening technologies

Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approval
Meanwhile, NCI trial will assess clinical utility

Crapo, Bennet, Cardin, and Scott introduce legislation to expand coverage of MCEDs

GRAIL presents PATHFINDER multi-cancer early detection screening study results

Fate of Illumina-GRAIL $7.1B merger uncertain as (1) EU blocks it, (2) FTC administrative law judge jettisons agency’s opposition

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NHS England will wait to consider NHS rollout of Galleri multi-cancer early detection test

YOU MAY BE INTERESTED IN

Pooled analysis questions reliability of an endpoint used in multi-cancer detection trials

NCI launches research network to evaluate emerging cancer screening technologies

Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approvalMeanwhile, NCI trial will assess clinical utility

Crapo, Bennet, Cardin, and Scott introduce legislation to expand coverage of MCEDs

GRAIL presents PATHFINDER multi-cancer early detection screening study results

Fate of Illumina-GRAIL $7.1B merger uncertain as (1) EU blocks it, (2) FTC administrative law judge jettisons agency’s opposition

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Heated discussion breaks out in recent meeting as FDA mulls standards for MCD approval
Meanwhile, NCI trial will assess clinical utility