Podcast - Who Owns Your DNA? Lessons Learned from 23andMe
State AG Pulse | CT AG Reacts to Genetic Data Breach
Pharmaceutical company sponsorship of diagnostic testing remains an area with a gaping divide between the views of regulators and industry, with regulators focused on potential fraud and abuse concerns while industry...more
Expectant parents, doctors, and regulators need to reconsider the rising use of gee-whiz genetic testing as doubts emerge about popular blood screenings to detect rare prenatal disorders and a costly test relied on by...more
Last week, the Food and Drug Administration (FDA) issued a safety communication warning the public about the potential risks of false results with genetic non-invasive prenatal screening tests (referred to as “NIPS” or...more
Last week, OIG posted Advisory Opinion No. 22-06 regarding a biopharmaceutical company’s (BioPharm Co.) arrangement to provide free genetic testing and genetic counseling services to patients potentially eligible for...more
I have written about genetic testing kits before, but this subject matter is worth repeating. I find that people don’t always understand the consequences when sending a swab to a genetic testing company. Consumer Reports...more
DOJ Announces Charges Against 138 Defendants for Alleged Health Care Fraud Schemes Resulting in $1.4 Billion in Losses, with Focus on Telemedicine - On September 17, 2021, the Department of Justice (DOJ) announced criminal...more
Scientists at the University of California-San Francisco (UCSF) have developed a single test, Metagenomic Next-Generation Sequencing (mNGS), that can rapidly identify infectious microbes in body fluids, increasing the speed...more
California’s “Genetic Information Privacy Act” (SB 980), vetoed on September 25, 2020 by Governor Gavin Newsom, would have established obligations for direct-to-consumer (“DTC”) genetic testing companies and others that...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
Nearly five years ago the U.S. Court of Appeals for the Federal Circuit (CAFC) decided the controversial case of Ariosa v. Sequenom. In Sequenom the invention was a radically new method of fetal genetic testing by amplifying...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
In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...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 Maryland General Assembly recently passed a bill that permits any person to directly or indirectly advertise diagnostic laboratory tests in the state, with certain limitations. The bill currently awaits the Governor’s...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
Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
More than three years after the June 15, 2012 deadline for providing it, the U.S. Patent and Trademark Office has issued its report on so-called "second opinion" genetic diagnostic testing, mandated by Section 27 of the...more
In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more