State AG Pulse | CT AG Reacts to Genetic Data Breach
In the 2023 Regular Session, Louisiana lawmakers passed Act No. 210 (the Act), which provided protections for employees who are absent from work to obtain genetic testing or a medically necessary cancer screening. The Act has...more
It’s hard to keep up with all the recent changes to labor and employment law, especially since the law always seems to evolve at a rapid pace. In order to ensure you stay on top of the latest changes and have an action plan...more
A new Louisiana law takes effect today to require employers to provide time off from work for medically necessary genetic testing and cancer screening. The new law also prohibits discrimination and retaliation against...more
Cancer, the "Emperor of All Maladies" as it has been termed, has been studied for millennia. President Nixon's "War on Cancer" resulted in slow but steady progress, aided by the biotechnology revolution, the development of...more
No painful procedure or biopsy needed. We can test our blood to diagnose and even predict cancer. The Human Genome Project, a joint effort between the U.S. Department of Energy and the National Institutes of Health, began...more
The Food and Drug Administration’s approval of Guardant Health’s Guardant360 CDx assay marks a new era for genetic mutation testing in cancer treatment. On August 7, 2020, the FDA approved the first diagnostic test that...more
Genetic instability has long been recognized as a hallmark of oncogenesis and tumor progression. The phenomenon was first identified cytogenetically, most famously by the Philadelphia chromosome in chronic myelogenous...more
In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been...more
On January 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a national coverage determination (“NCD”) that authorizes Medicare coverage of next-generation sequencing (“NGS”) as a diagnostic laboratory...more
On October 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed decision memo with a national coverage determination (“NCD”) that would allow for Medicare coverage of next-generation sequencing...more
The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more
The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more
The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved...more
Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more
A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more
On March 6, 2018, 23andMe, Inc. received the first-ever FDA authorization for a direct-to-consumer genetic test that analyzes gene mutations to help predict a subject’s risk of developing specific cancers. 23andMe already...more
On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more
Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone...more
On Wednesday, the National Institutes of Health (NIH) announced that the agency had reached an understanding with the family of Ms. Henrietta Lacks regarding access to genomic data for the HeLa cell line, which was derived...more