“Molecular diagnostic techniques are part of the ancillary arsenal of anatomic pathologists. Advances in technology and knowledge regarding disease pathogenesis, tumorigenesis, and immune function contribute to the development of these assays. However, each technique,...
Aligning Genetic and Genomic Test Reimbursement With Value of Tests
“In the U.S., clinical genetic and genomic testing labs provide diagnostic, predictive, prognostic, and theragnostic tests with perceived clinical value—a perception is frequently untethered from reality. This means that many patients are inadvertently harmed when...
Test Reference
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings. The post Test Reference...
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 shards of...
June 2022 – The Data Driven Point of View Newsletter: “1 in 10 Americans Have Received a Test Result Report Inaccuracy”
Patients deserve accurate genetic or genomic test results that impact therapy and medical management decisions. Patients were interviewed by the PEW Trusts Foundation to better understand their perception on this issue. An online discussion board and a national survey...
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),...
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...
Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks
The #FDA released a statement today ALERTING laboratory personnel and healthcare providers about #Illumina cybersecurity vulnerabilities. Illumina supplies the majority of genomic laboratories with instrumentation to sequence DNA. The letter to healthcare providers...
Support for VALID in the FDA Safety and Landmark Advancement Act Draft of 2022
————— The letter below was addressed and emailed to Senators Burr and Murray on May 21, 2022: We at the independent and nonprofit Center for Genomic Interpretation (CGI) are writing in support of the FDA Safety and Landmark Advancement Act draft, specifically the...
May 2022 – The Data Driven Point of View Newsletter: Is Whole Exome or Whole Genome Sequencing Better?
————— Oftentimes, the terms Whole Exome Sequencing (WES) and Whole Genome Sequencing (WGS) are used interchangeably. This is an inappropriate usage of these two distinct sequencing options. More importantly, is one demonstrably better than the other to improve patient...