After decades of intense scientific research into developing gene editing technologies, and more than a few setbacks, the field has produced a number of success stories in recent years, demonstrating that regulatory agencies...more
An international cadre of scientists* from almost 70 institutions worldwide recently reported their findings in the scientific journal Nature that the domesticated dog (Canis familiaris) arose from two populations of...more
As gene editing techniques come to the fore in the UK and elsewhere, industry increasingly needs clarity on the breeder's exception to plant variety rights. Originally published on IAM media.com on May 2022....more
In the past several months we have written a couple of times about the world of anonymous parentage and the conflict it has unintentionally ignited. In October we published “23 and EEEEEE” excerpting from the Philadelphia...more
The dire wolf (Canis dirus), prototype of the various wolves that were important members of the House Stark family of characters in Game of Thrones, was found uniquely in North America until its extinction in the late...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
In the last days of the most recent legislative session, the California State Legislature was busy passing several privacy bills set to impact businesses. The most recent, the Genetic Information Privacy Act, would require...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
Lions (Panthera leo) once were a widely distributed group of terrestrial mammals, ranging during the Pleistocene (from about 2,580,000 to 11,700 years ago) in Eurasia, Africa, and North America, with species that included the...more
As the coronavirus pandemic engulfs us, it is easy to imagine the litigation that may follow—including tort suits seeking damages for illness or death allegedly caused by negligent or reckless exposure. Possible fact patterns...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 avocado, having gained popularity (at least in the U.S.) as a convenient (and delicious) vehicle for consuming otherwise not particularly healthful corn chips, has more recently been hailed as a "superfood" when consumed...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
Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more
Most experts in traumatic brain injury (TBI) agree that there is a high degree of variability in outcomes after TBI, including concussions (usually characterized as “mild” TBIs – mTBI.) In other words, this injury is...more
Genetic information is basically one’s DNA sequence, which includes health information and genetic information about the individual and their family. It is at the core of one’s individual privacy, as well as providing...more
While the rest of the patent world was focused on Supreme Court opinions (issued and pending) and Congressional action vel non on threats like patent trolls, the consolidated Multi District Litigation between Myriad Genetics...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