A recent article published in ProPublica has so much amazing information that we will be outlining today and tomorrow. Part 1 is below. Part 2 will be tomorrow. Happy reading! In 2020, the American College of Obstetricians and Gynecologists...
Blog
Congress Needs to Update FDA’s Ability to Regulate Diagnostic Tests, Cosmetics
“According to the Centers for Disease Control and Prevention, 70% of health care decisions are based on clinical lab tests. The potential for the future is even greater, with early detection and better treatment guidance, and opportunities for new targeted...
Disagreement in Clinical Genetics Could Determine a Mother’s Freedom
An article recently published in Nature discusses a legal case in which a #cardiology#genemutation classification has been evaluated by 2 expert groups. The stakes of an accurate classification are high since they impact the freedom or continued...
Myriad Genetics to Submit Hereditary Cancer Risk Variants to ClinVar in 2023
Myriad Genetics will be contributing to the #ClinVar database starting spring of 2023, including BRCA1 and BRCA2 variants! "Over recent months, Myriad has focused on lifting barriers that have hindered clinicians, health systems, and genetic counselors...
Texas Doctor Pleads Guilty to Role in $54 million Medicare Fraud Scheme including Hereditary Cancer Genetic Testing
"A Texas doctor pleaded guilty today for his role in a $54 million scheme to defraud Medicare by prescribing durable medical equipment and cancer genetic testing without ever seeing, speaking to, or otherwise treating patients."...
Grail Galleri testing proving to have high false positive rates
Last year, Grail reported that 44.6% of patients with positive test results on Galleri actually had cancer. Galleri is a multi-cancer early detection test. However, in the latest analysis, the figure, known as the positive predictive value, has fallen to 38.0%. ...
Medical Device Innovation Consortium (MDIC) Launching New Initiative for Somatic Reference Samples
The Medical Device Innovation Consortium (MDIC) is launching a new initiative testing somatic (tissue) reference samples to improve validation, as well as the regulatory review process for cancer diagnostic testing based on next generation sequencing (NGS). This will...
Should Laboratory Developed Tests (LDTs) be available to the general population before they have been fully demonstrated to work?
The New York Times just released an article on one of the new blood screening tests for healthy individuals to detect cancer early - GRAIL Galleri. ExactSciences is following Grail’s lead with a similar Laboratory Developed Test (LTD) offering. Minuscule...
How can you spot fraudulently recruited COVIDera Hereditary Cancer Tests?
𝗢𝗻𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗹𝗮𝗿𝗴𝗲𝘀𝘁 𝗵𝗲𝗮𝗹𝘁𝗵 𝗰𝗮𝗿𝗲 𝗳𝗿𝗮𝘂𝗱 𝘀𝗰𝗵𝗲𝗺𝗲𝘀 𝗲𝘃𝗲𝗿 𝗰𝗵𝗮𝗿𝗴𝗲𝗱 𝗯𝘆 𝘁𝗵𝗲 𝗨𝗦 𝗗𝗲𝗽𝗮𝗿𝘁𝗺𝗲𝗻𝘁 𝗼𝗳 𝗝𝘂𝘀𝘁𝗶𝗰𝗲 𝘄𝗮𝘀 𝗳𝗼𝗿 𝗚𝗘𝗡𝗘𝗧𝗜𝗖 𝗧𝗘𝗦𝗧𝗜𝗡𝗚! Variations of 𝘁𝗵𝗲 𝗳𝗿𝗮𝘂𝗱 𝗮𝗿𝗲 𝗼𝗻𝗴𝗼𝗶𝗻𝗴 𝗮𝗻𝗱 𝗻𝗮𝘁𝗶𝗼𝗻 𝘄𝗶𝗱𝗲, and so severe that the US HHS Office of Inspector General maintains a website, with a professionally...
Caris Life Sciences Pays Over $2.8 Million to Settle False Claims Act Allegations from Delay in Submission of Genetic Cancer Screening Tests
“Caris Life Sciences, Inc. (Caris) has agreed to pay $2,886,674.86 to resolve allegations that it violated the False Claims Act in an alleged nationwide scheme to improperly bill Medicare for laboratory tests”* The U.S. Department of Health and Human Services (HHS),...