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FDA Signals Willingness to Approve CRISPR-Based Treatment for Sickle Cell Anemia

Ever since Watson and Crick ended their seminal Nature paper in 1953 by saying that:  "It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the...more

Neanderthal Ancestors Can Be Human Guardian Angels for COVID Infection, Too

When it comes to SARS-CoV-2 infection (and resulting COVID-19), it seems our Neanderthal ancestors giveth and taketh away.  Genetic material inherited from interbreeding between Neanderthals and early humans has been shown to...more

Epigenetic Changes Implicated in Age-related Diminution in Vision and Its Possible Reversal

The Fountain of Youth -- an enduring aspiration, particularly as the ravages of age reduce human faculties prior to leading inexorably to death.  Reduction in sight is the human faculty that can have the greatest effect on...more

Neanderthal-specific Variants in Sodium Ion Channel Gene Associated with Sensitivity to Pain in Modern Humans

Over the past decade, genetic archeology has revealed two branches of the human family tree, one known since the 19th Century (the Neanderthals) and the other more recently discovered (the Denisovans, an Asian relative of the...more

Appendiceal Cancer Shows Age-related Somatic Gene Variants with Potential Diagnostic Relevance

Cancer of the appendix is a very rare form of cancer, having an incidence of 0.12 per 1,000,000 person-years (Siegel et al., 2020, Cancer statistics 2020 70:7-30).  Incidence is rising (by 232% from 2000-2016 in the U.S.)...more

Broad Institute Loses Appeal in European Patent Office, Patents Remain Revoked

Earlier this year, and almost one year to the day (January 17, 2019) that the Opposition Division (OD) of the European Patent Office revoked in its entirety European Patent No. EP 2771468, the Technical Board of Appeal...more

Inherited Neanderthal Gene Encodes Genetic Risk for COVID-19

Svante Pääbo created the science of detecting Neanderthal DNA in archeological samples (and living humans) almost single-handedly (see Neanderthal Man: In Search of Lost Genomes).  So it will come as little surprise to many...more

Sequence Variants in Human Olfaction Genes Associated with Perceptual Differences

Perception by the five human senses (sight, hearing, taste, smell, and touch) varies significantly between individuals and populations.  Some use these differences to their advantage, such as sommeliers capable of detecting...more

Chromosomal Rearrangements Associated with Chemotherapeutic Drug Resistance

Chemotherapeutic drug resistance is one reason cancer remains an unsolved clinical problem despite the efforts ever since President Nixon declared his "War on Cancer" in 1971.  Cancer cells, due in part to the genetic...more

Alternative APOE Gene Variants Associated with Different Diseases of Aging

The inherent, ineluctable unpredictability of biology can be the basis for biological patent claims being non-obvious (lacking the requisite "reasonable expectation of success"; see, e.g., OSI Pharmaceuticals v. Apotex) and...more

Genetic Research Continues to Reveal Ancestry Relationships in Early Human Migrations

The human tendency to identify with tribes of "like" humans (related by family, place of origin, or religion, among other bases) was perverted during the Twentieth Century (and in some places remains so today) into the idea...more

CVC Reply No. 2 to Broad's Opposition No. 2 to CVC's Motion No. 2 to Be Accorded Benefit of Priority

March 23rd was the deadline for the parties in Interference No. 106,115 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the...more

Correlation Found Between Left-Handedness and Genetic Markers Associated with Neurological Disease

Left-handedness is a uniquely human trait, with 90% human populations globally being right-handed since the Paleolithic (extending from 3.3 million years ago to the end of the Pleistocene).  A feature of motor control, the...more

11/14/2019  /  DNA , Human Genes , Life Sciences

BRCA2 Gene Mutations Associated with Risk of Childhood Lymphoma

The BRCA2 gene is one member of a pair of genes that changed the patent landscape several years ago, when the Supreme Court ruled that "mere" isolation was insufficient to render genomic embodiments thereof patent eligible,...more

Using Genetics to Uncover Human History

Human history is often something modern man only sees as through a glass, darkly. This is particularly the case when that history did not occur in the Mediterranean, the Nile Valley, India, or China, or when there is no...more

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

Dr. Cook-Deegan Brings the Medical Community Up to Date on the Myriad Case

In an article in The Cancer Letter entitled "Robert Cook-Deegan's Viewers' Guide To the Super Bowl of Gene Patent Cases," Professor Robert Cook-Deegan (at right) of the Institute for Genome Sciences & Policy and Sanford...more

Utah Judge Denies Myriad's Preliminary Injunction Motion

In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more

Gene-by-Gene Cries Uncle, Settles with Myriad Genetics

Gene-by-Gene, Inc. was one of the first direct-to-consumer (DTC) genetic diagnostics companies to announce that it would offer BRCA1/BRCA2 testing after the Supreme Court's decision last June that certain of Myriad Genetics'...more

Sequenom Files Opening Brief in Appeal of Summary Judgment on Section 101 Grounds

Earlier this week, Sequenom, Inc. filed its opening brief in Ariosa Diagnostics, Inc. v. Sequenom, Inc., appealing summary judgment that its licensed claims to a genetic diagnostic method for detecting fetal diseases and...more

23andMe Named in Class Action Lawsuit

Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more

FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing

As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without...more

Where Do We Stand?

Some of our commenters have asked (with greater or lesser degrees of stridency) that we "take a position" on claims like the Myriad method claims at issue in the lawsuits brought against Ambry Genetics, Gene-by-Gene, and...more

Myriad Genetics Sues Quest for Patent Infringement

Turnabout being fair play, Myriad Genetics today filed suit against Quest Diagnostics, Inc. and Quest Diagnostics Nichols Institute for patent infringement in an action brought in the Federal District Court for the District...more

Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents

After a brief hiatus that saw Counsyl and Quest Diagnostics file declaratory judgment actions in alternate venues, Myriad has filed yet another lawsuit against a genetic diagnostics company that brought its own BRCA gene...more

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