Using ctDNA as an endpoint in your cancer clinical trial? FDA wants to hear from you

Monica Bertagnolli joins Friends of Cancer Research board of directors

Monica Bertagnolli, former director of NIH and NCI, joined the Friends of Cancer Research as board of directors.

March 07, 2025

FDA grants de novo authorization for PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test

Labcorp announced it has received de novo marketing authorization from FDA for PGDx elio plasma focus Dx—the industry’s first and only kitted, pan-solid tumor liquid biopsy test.

August 09, 2024

Vol.50 No.32

Clinical Roundup

Novel liquid biopsy methodology can track evolution of metastatic prostate cancer

DNA/RNA material contained in circulating extracellular vesicles secreted into the bloodstream by tumor cells captures cancer genomics and transcriptomic evolution in patients with metastatic prostate cancer, according to a new study.

July 26, 2024

Vol.50 No.30

In Brief

Monica Bertagnolli and Brett Guthrie named Friends 2024 Cancer Leadership Award recipients

Monica BertagnolliBrett GuthrieNIH Director Monica Bertagnolli and Rep. for Kentucky’s 2nd congressional district, Brett Guthrie were named recipients of Friends of Cancer Research 2024 Cancer Leadership Award.

July 19, 2024

Vol.50 No.29

Clinical Roundup

Oncology drugs approved post-2020 more likely to include postmarketing approaches to collecting data in underrepresented populations

Friends of Cancer Research characterized postmarketing requirements and commitments over the last decade. The perspective article, titled “An evaluation of novel oncology approvals with a PMR/C for assessing data in racial and ethnic populations underrepresented in premarket clinical trials,” provides insights into FDA’s expectations for representation of race and ethnicity in oncology clinical trials.

June 21, 2024

Vol.50 No.25

Clinical Roundup

AI-based blood test outperforms ultrasound in early liver cancer detection

Helio Genomics, an AI-driven healthcare company specializing in diagnostics technology and test development for cancer detection, has released results from its latest clinical trial demonstrating the superior performance of their HelioLiver Dx test compared to ultrasound.

June 14, 2024

Vol.50 No.24

Using ctDNA as an endpoint in your cancer clinical trial? FDA wants to hear from you

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Monica Bertagnolli joins Friends of Cancer Research board of directors

FDA grants de novo authorization for PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test

Novel liquid biopsy methodology can track evolution of metastatic prostate cancer

Monica Bertagnolli and Brett Guthrie named Friends 2024 Cancer Leadership Award recipients

Oncology drugs approved post-2020 more likely to include postmarketing approaches to collecting data in underrepresented populations

AI-based blood test outperforms ultrasound in early liver cancer detection

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