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FDA Grants Breakthrough Device Designation to Gene Solutions' SPOT-MAS 10 for Cancer Screening

FDA Grants Breakthrough Device Designation to Gene Solutions' SPOT-MAS 10 for Cancer Screening

Gene Solutions, a biotechnology company, has received the U.S. FDA Breakthrough Device Designation for its SPOT-MAS 10 multi-omic blood test. This test is designed to detect cancer-associated signals by analyzing circulating cell-free DNA methylation and fragmentomic signatures using a machine-learning-based algorithm. The test is intended for use as an adjunctive screening tool in asymptomatic adults aged 40 and older, covering various cancers such as breast, lung, and colorectal. The designation highlights the test's potential to provide more effective diagnosis of life-threatening diseases compared to current options. SPOT-MAS 10 aims to complement existing screening programs and expand opportunities for cancers lacking established pathways.
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Kelun-Biotech Unveils Promising Phase II Data for Lunbotinib in RET Fusion-Positive NSCLC at ASCO 2026

Kelun-Biotech Unveils Promising Phase II Data for Lunbotinib in RET Fusion-Positive NSCLC at ASCO 2026

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. presented pivotal Phase II study results for their next-generation selective RET inhibitor, lunbotinib fumarate, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The study focused on patients with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The trial included 71 pre-treated patients and 92 treatment-naïve patients, showing an objective response rate of 81.3% in treatment-naïve and 87.1% in pre-treated patients. The drug demonstrated significant efficacy, particularly in patients with central nervous system metastases, achieving a 30% intracranial complete response rate. Lunbotinib fumarate was well tolerated, with minimal treatment-related adverse events leading to discontinuation.
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Research Links Poor Sleep to Increased Cancer Risk in Under-50s

Research Links Poor Sleep to Increased Cancer Risk in Under-50s

Recent studies presented at the American Society of Clinical Oncology's annual meeting in Chicago have highlighted a potential link between poor sleep patterns and an increased risk of early-onset cancers in individuals under 50. Conducted by the MD Anderson Cancer Center in Houston, the research analyzed health data from over 18 million U.S. adults aged 18 to 50. Findings suggest that those with irregular sleeping patterns are more likely to develop cancers such as bowel, breast, uterine, or ovarian cancer. In some cases, individuals diagnosed with insomnia were found to be three times more likely to develop cancer within five years. The studies underscore sleep disruption as a potentially modifiable risk factor in early-onset cancer risk stratification, warranting further investigation.
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Illumina Launches New MRD Kit to Enhance Cancer Research Capabilities

Illumina Launches New MRD Kit to Enhance Cancer Research Capabilities

Illumina Launches New MRD Kit to Enhance Cancer Research Capabilities
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GRAIL's NHS-Galleri Trial Shows Significant Reduction in Stage IV Cancer Diagnoses

GRAIL's NHS-Galleri Trial Shows Significant Reduction in Stage IV Cancer Diagnoses

GRAIL, Inc. has announced the results of its NHS-Galleri trial, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial, conducted in collaboration with NHS England, evaluated the Galleri multi-cancer early detection (MCED) test. Over three years, the trial involved 142,250 participants aged 50 to 77. The results showed a 22% reduction in Stage IV cancer diagnoses in the second screening round and a 26% reduction in the third round. The Galleri test increased cancer detection rates four-fold when added to standard screening, and reduced emergency cancer diagnoses by 25%. The trial aims to detect cancers earlier, potentially allowing for curative treatment.
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Kelun-Biotech Presents Phase II Data for Lunbotinib Fumarate in RET Fusion-Positive NSCLC at ASCO

Kelun-Biotech Presents Phase II Data for Lunbotinib Fumarate in RET Fusion-Positive NSCLC at ASCO

Kelun-Biotech Presents Phase II Data for Lunbotinib Fumarate in RET Fusion-Positive NSCLC at ASCO
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Pfizer and Innovent Biologics Announce $10.5 Billion Cancer Treatment Collaboration

Pfizer and Innovent Biologics Announce $10.5 Billion Cancer Treatment Collaboration

Pfizer and Innovent Biologics Announce $10.5 Billion Cancer Treatment Collaboration
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BeOne Medicines Reveals Phase 3 HERIZON-GEA Trial Results with Significant Survival Benefits

BeOne Medicines Reveals Phase 3 HERIZON-GEA Trial Results with Significant Survival Benefits

BeOne Medicines Reveals Phase 3 HERIZON-GEA Trial Results with Significant Survival Benefits
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FDA Grants Breakthrough Device Designation to Gene Solutions' SPOT-MAS 10 for Cancer Screening

FDA Grants Breakthrough Device Designation to Gene Solutions' SPOT-MAS 10 for Cancer Screening

FDA Grants Breakthrough Device Designation to Gene Solutions' SPOT-MAS 10 for Cancer Screening
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Melanoma Focus Launches Campaign to Train Barbers in Skin Cancer Detection

Melanoma Focus Launches Campaign to Train Barbers in Skin Cancer Detection

Melanoma Focus Launches Campaign to Train Barbers in Skin Cancer Detection
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Blood Testing Added to Colorectal Cancer Screening Recommendations by American Cancer Society

Blood Testing Added to Colorectal Cancer Screening Recommendations by American Cancer Society

The American Cancer Society has updated its colorectal cancer screening guidelines to include blood testing as an option for adults aged 45 and older. This addition aims to provide an alternative for individuals who decline or cannot complete traditional screening methods like colonoscopies or stool-based tests. The blood test, known as the Shield test, was approved by the FDA in 2024 and offers a less invasive option for detecting colorectal cancer.
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American Cancer Society Recommends Blood Testing for Colorectal Cancer Screening to Address Rising Cases

American Cancer Society Recommends Blood Testing for Colorectal Cancer Screening to Address Rising Cases

The American Cancer Society has updated its guidelines to include blood testing as a screening option for colorectal cancer. This decision aims to increase screening rates, particularly among younger populations, as colorectal cancer has become the leading cause of cancer deaths among people under 50 in the United States. The new blood test, known as the Shield test, detects tumor DNA in the blood and is recommended for adults aged 45 and older who are at average risk and have not completed or declined other screening methods like colonoscopies or stool tests. Despite its lower sensitivity in detecting precancerous polyps compared to other methods, the blood test offers a less invasive option for those unwilling or unable to undergo traditional screenings.