MedPath

GENOMIC HEALTH, INC.

🇺🇸United States
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JAMA Oncology Study Confirms Oncotype DX Test Effectiveness Across All Racial and Ethnic Groups

• Comprehensive JAMA Oncology review validates that the Oncotype DX Breast Recurrence Score test accurately predicts chemotherapy benefit for breast cancer patients regardless of race or ethnicity. • The largest real-world SEER registry analysis to date, involving over 171,000 breast cancer patients, provides new evidence supporting the test's consistent performance across diverse populations. • Despite a 40% higher breast cancer mortality rate among non-Hispanic Black women compared to non-Hispanic White women, the study confirms the test's reliability in guiding precision treatment decisions for all patients.

Exact Sciences' Oncodetect Shows Promise in Detecting Residual Colorectal Cancer

• Exact Sciences' Oncodetect MRD test demonstrates strong performance in detecting molecular residual disease in colorectal cancer patients, according to new clinical validation data. • The Alpha-CORRECT study showed Oncodetect achieved 78% sensitivity post-surgery and 91% during surveillance, with 80% and 94% specificity, respectively. • Beta-CORRECT study confirms a significant association between MRD positivity and recurrence in stage III colon cancer, extending prognostic value to other stages. • Exact Sciences plans to launch Oncodetect in Q2 2025 with Medicare coverage, supported by strategic partnerships for multi-cancer evidence generation.

Blood Tests Show Promise in Personalizing and Detecting Cancer Early

• A new blood test analyzes circulating tumor DNA to personalize cancer treatment by identifying specific mutations and recommending tailored therapies. • The Target National trial at The Christie hospital aims to recruit 6,000 patients to assess if 'liquid biopsies' improve outcomes, potentially becoming routine on the NHS. • Oxford University researchers developed the TriOx test, demonstrating high sensitivity (94.9%) and specificity (88.8%) in detecting early-stage cancers across six types. • Early results from personalized treatment approaches show significant benefits, such as tumor shrinkage in advanced cases, highlighting the potential for improved patient outcomes.

Barriers to Personalized Medicine: Payer Reimbursement Challenges Slow Diagnostic Test Adoption

• Less than 5% of US private companies currently reimburse for genetic tests, creating a significant barrier to personalized medicine adoption despite its potential to reduce healthcare costs. • Studies show personalized medicine diagnostic tests can generate savings between $600-$28,000 per patient, with successful examples like Oncotype DX demonstrating $1,930 savings per patient through reduced chemotherapy needs. • Pay-for-performance models are emerging as a potential solution, growing at 26% annually in the US, offering a win-win approach for pharmaceutical companies and payers in personalized medicine implementation.
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