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Folowing AACR, ASCO Supports FDA's Guidance for LDTs
The ASCO statement corroborates the need for regulation of laboratory-developed tests, which are increasingly being used to guide personalized treatment in oncology as well as other therapeutic areas.
ASCO supports the FDA's Framework Guidance that proposes a risk-based approach to regulation of laboratory-developed tests (LDTs), particularly genomic tests that, increasingly, are being used to guide therapy selection for patients with cancer. Failure of such tests to perform as intended can lead to patients receiving an inappropriate and potentially harmful treatment or, alternatively, not receiving a treatment that has the potential to benefit them.
Prevailing regulations that apply to LDTs offered for clinical use, namely CLIA, do not assess the safety and effectiveness of LDTs offered by laboratories. Rather, they determine that the laboratory follows generally accepted standards for good laboratory practices. Under CLIA, laboratories are required to demonstrate the analytical validity of the tests they offer, that is, that the test accurately and reproducibly measures what it claims to measure. However, CLIA does not evaluate the clinical validity of a test, ie, the test’s ability to detect the clinical condition for which the test is intended. Nor does CLIA evaluate the clinical utility of the test, ie, whether or not patient outcomes are improved by using the test.
Press release from ASCO: http://bit.ly/1og3UPg
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Uniting to Support Patients With Cancer Beyond Treatment
November 17th 2024Kasey Bond, MPH, of Perlmutter Cancer Center at NYU Langone Health, speaks to why it’s vital to keep patients at the center of all strategic partnerships between academic institutions and community-based oncology practices.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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Bridging Cancer Care Gaps and Overcoming Medical Mistrust
November 13th 2024In this clip from our interview with Oscar B. Lahoud, MD, cochair of our Institute for Value-Based Medicine® evening hosted with NYU Langone Health, he addressed medical mistrust in underrepresented communities.
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How English- and Spanish-Preferring Patients With Cancer Decide on Emergency Care
November 13th 2024Care delivery innovations to help patients with cancer avoid emergency department visits are underused. The authors interviewed English- and Spanish-preferring patients at 2 diverse health systems to understand why.
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