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The contractors will provide limited coverage for ctDNA tests if the patient has a personal history of stage II to stage III colorectal cancer.
The Medicare Administrative Contractor will cover ctDNA tests if the patient has a personal history of colorectal cancer.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
In a local coverage article, Medicare contractors in the MolDx program added prostate cancer to the covered indications for the test.
The classifiers are considered reasonable and necessary if the patient can tolerate chemotherapy and it's being considered as a treatment for the patient.
The MAC will consider PGx testing reasonable and necessary after a physician has narrowed a patient's treatment options to specific medications.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
Under the LCD, pharmacogenomic tests are covered when medications are being considered for use that are known to have a clinically actionable gene-drug interaction.
The decision comes after Myriad requested expanded coverage for women with breast cancer seeking information about extending endocrine therapy.
The DXRX marketplace, planned for launch in the fourth quarter of 2020, will provide a way for pharmaceutical companies, diagnostic firms, and laboratories to collaborate.
Two COVID-19 vaccine developers have released their trial protocols to build public trust, the New York Times reports.
A new analysis finds the rapid COVID-19 test from DnaNudge to be highly accurate, Reuters reports.
In Science this week: global citizens' assembly on genome-editing technologies proposed, epigenetic markers predict metformin response, and more.
According to the Verge, many US states are not including positive results from rapid COVID-19 testing in their case numbers.