GRAIL has submitted an FDA premarket approval application for its Galleri multi-cancer early detection test, supported by data from more than 25,000 participants in US and UK clinical trials.
A study reports that post-treatment circulating tumor DNA levels may better predict recurrence in HER2-positive breast cancer patients than current pCR measures.
Three abstracts showcase PreciseBreast's ability to predict recurrence risk in early-stage invasive breast cancer using digital pathology.
New diagnostic chip pulls packets released from tumor cells out of blood, showing whether cancer cells died during chemotherapy infusion.
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Two peer-reviewed studies demonstrate superior risk stratification compared to traditional clinicopathologic features and competitor testing.
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The test can now be used to identify HER2-positive metastatic breast cancer patients that could be eligible for Enhertu.
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A blinded validation in more than 400 women shows the test provides clearer guidance on recurrence risk and radiation therapy decisions.
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Johns Hopkins researchers found the blood test detected multiorgan tissue damage in patients experiencing immune-related adverse events from checkpoint inhibitor therapy.
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A study of 431 patients demonstrates the test can detect cancer recurrence months ahead of standard imaging.
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Research analyzing cell-free DNA fragmentation patterns in healthy individuals reveals physiological confounders that could improve test accuracy.
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Transaction expands Natera’s solid tumor MRD capabilities and adds ultrasensitive phased variant technology with detection below 0.1 parts per million.
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The collaboration combines AI-based analysis tools with a next-generation sequencing system to support labs performing tumor and liquid biopsy testing.
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The new guidelines allow self-collected vaginal samples for HPV testing and outline criteria for safely discontinuing cervical cancer screening.
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The test receives premarket approval as an aid in biopsy decision-making for men 50 and older with elevated PSA levels.
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The Mercy Halo test demonstrates performance similar to low-dose CT screening with the potential to reach underscreened populations.
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The standards developed through a public-private partnership contain seven oncogenic mutations selected for clinical significance.
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Coverage applies to stage II and III breast cancer patients across three major subtypes for up to six years of recurrence monitoring.
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Research demonstrates the MRD assay’s utility in tracking disease progression and predicting treatment outcomes.
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