Reports from Memorial Sloan-Kettering Cancer Center Advance Knowledge in Cancer (Regulation of Laboratory-Developed Tests in Preventive Oncology: Emerging Needs and Opportunities): Cancer

2022 AUG 22 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Research findings on cancer are discussed in a new report. According to news originating from New York City, New York, by NewsRx correspondents, research stated, “Cancer predictive or diagnostic assays, offered as Laboratory-Developed Tests (LDTs), have been subject to regulatory authority and enforcement discretion by the US Food and Drug Administration.”

Our news reporters obtained a quote from the research from Memorial Sloan-Kettering Cancer Center: “Many LDTs enter the market without US Food and Drug Administration or any regulatory review. The Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments focuses on analytic performance, but has limited oversight of the quality or utility of LDTs, including whether patients have been harmed as a result of their use. Increasingly, LDTs for cancer risk or early detection have been marketed directly to consumers, with many LDT developers depicting these tests, requested by patients but ordered by personal or company-associated physicians, as procedures falling under the practice of medicine. This patchwork of regulation and enforcement uncertainty regarding LDTs and public concerns about accuracy of tests given emergency authorization during the COVID-19 pandemic led to the Verifying Accurate Leading-edge IVCT (in vitro clinical test) Development Act of 2021. This pending federal legislation represents an opportunity to harmonize regulatory policies and address growing concerns over quality, utility, and safety of LDTs for cancer genomics, including tests marketed directly to consumers.”

According to the news editors, the research concluded: “We review here questions regarding the potential benefits and harms of some cancer-related LDTs for cancer risk and presymptomatic molecular diagnosis, increasingly marketed to oncologists or directly to the worried well. We offer specific proposals to strengthen oversight of the accuracy and clinical utility of cancer genetic testing to ensure public safety.”

For more information on this research see: Regulation of Laboratory-Developed Tests in Preventive Oncology: Emerging Needs and Opportunities. Journal of Clinical Oncology, 2022. The publisher for Journal of Clinical Oncology is American Society of Clinical Oncology (ASCO).

A free version of this journal article is available at https://doi.org/10.1200/jco.22.00995.

Our news journalists report that more information may be obtained by contacting Kenneth Offit, Clinical Genetics Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, United States. Additional authors for this research include Catherine M. Sharkey, Dina Green, Xiaohan Wu, Magan Trottier, Jada G. Hamilton, Michael F. Walsh, Sita Dandiker, Sami Belhadj, Steven M. Lipkin, Thelma Alessandra Sugranes, Michele Caggana, Zsofia K. Stadler.

ORCID is an identifier for authors and includes bibliographic information. The following is ORCID information for the authors of this research: Jada G. Hamilton (http://orcid.org/0000-0001-8377-4666), Michael F. Walsh (http://orcid.org/0000-0001-5006-6778), Sita Dandiker (http://orcid.org/0000-0003-3837-7690), Sami Belhadj (http://orcid.org/0000-0002-0528-9187), Steven M. Lipkin (http://orcid.org/0000-0002-0603-9139), Zsofia K. Stadler (http://orcid.org/0000-0002-6985-2864).

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