Genetic Testing

News & Analysis as of

23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

Direct-to-Consumer Genetic Test Authorized by FDA

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

Game Over for Myriad -- Update: (Or, and then there was one were none)

As discussed for the past month, Myriad has finally given up trying to defend its BRCA gene testing franchise. The one remaining matter, Myriad's case against GeneDx has settled, as announced by the company today....more

Myriad Throws in the Towel

In the aftermath of the Supreme Court's decision in AMP v. Myriad Genetics in 2013, Myriad (paradoxically to those either not paying attention or who over interpreted the scope of the Court's holding in its opinion) filed...more

Blog: 23andMe Advances Its Goal of Creating Commercialized Database from Consumer Genetic Testing

On January 12, 23andMe announced an agreement with Pfizer to provide the drug company with access to anonymous, aggregated information from consumers who bought 23andMe’s test over the past seven years to learn about their...more

What Employers Need to Know - Requests for Medical Information and the Genetic Information Nondiscrimination Act: Avoiding a...

The Genetic Information Non-discrimination Act took effect in November 2009. It should also be noted that many States, including Maryland, have separate statutes prohibiting the acquisition of genetic information and...more

Good News, Bad News and More Inflammatory Rhetoric in Myriad Genetics Case

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

Myriad Appeals Adverse Preliminary Injunction Decision

On March 13, Myriad Genetics filed a Notice of (interlocutory) Appeal with the Federal Circuit. Myriad is seeking to have the Court review and reverse the District Court's denial of the company's preliminary jnjunction...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

Six Hot Opportunities in Genomic Medicine

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

Task Force Recommendation for BRCA-Related Genetic Testing

The U.S. Preventive Services Task Force (“USPSTF”) recently issued a report regarding the effectiveness of BRCA1/BRCA2 genetic tests for women and within the report, issued recommendations for preventive screening for women...more

2013 Virginia Employment Law Pocket Guide

In this guide: - Employment At-Will - Right to Work - Employment of Children - Restrictive Covenants in Employment Contracts - Virginia Human Rights Act - Virginians with Disabilities...more

Why a Class Action Lawsuit Against 23andMe? Quick Hit Q&A With Audet & Partners

The bad news for 23andMe keeps coming. In late November, we learned that the U.S. Food and Drug Administration had ordered the company to stop selling its $99 DNA testing kit owing to a number of accuracy and validity...more

Myriad Genetics Sues LabCorp over BRCA Gene Testing

The very latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is LabCorp (Laboratory Corporation of America), located in Burlington, North Carolina. ...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

Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back

The latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is Invitae Corp. located in San Francisco. Myriad sued Invitae on Monday in the District of...more

Patients Push Back on FDA Threats to 23andMe Genetic Testing Products

In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe...more

Health Care Reform Update -- November 25, 2013

In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled. Excerpt from...more

California Court Holds Diagnostic Claims Not Patent-Eligible

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

Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing

On July 19th, Myriad Genetics amended its complaint against Ambry Genetics to include claims to its patents relating to colon cancer predictive genetic diagnostic testing (amended complaint). ...more

Bioethicists "Urge Maximal Transparency" in Response to 23andMe Patent

Last week, we discussed a patent, recently issued to 23andMe, Inc., that has created some controversy. The patent, U.S. Patent No. 8,543,339, is directed to a system for identifying a preferred gamete donor from among the...more

Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics

Whether relying on Carl von Clausewitz or Jack Dempsey for the sentiment, Counsyl, Inc., a genetic diagnostic testing company has decided that the best defense against Myriad Genetics is a good offense and, accordingly, has...more

Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies

Not to be outdone by defendants Ambry Genetics and Gene-by-Gene's 109-page brief in opposition to Myriad's Preliminary Injunction Motion, Myriad has now filed a Reply Brief weighing in at 140 pages (page limits in briefs...more

Defendants' Response to Myriad's Preliminary Injunction Motions - Myriad Genetics v. Ambry Genetics Corp. and Myriad Genetics v....

Last month, Ambry Genetics and Gene By Gene responded to Myriad's motion for preliminary injunction in a 109 page brief that sets out its invalidity case as well as the basis for its antitrust counterclaims. Supported by...more

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