Genetic Testing

News & Analysis as of

Genetic Testing, Genome Sequencing, and the FDA

In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more

Three Pressing Challenges for Personalized Medicine

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

Millennium Health to Pay $256 million in False Claims Act Settlement

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

USPTO Report on State of Confirmatory Genetic Testing Comes off the Waffle Iron

In 2011—after the Fed. Cir. decision in Myriad upholding claims to BRACA1 and 2 genes—the PTO was tasked by a section of the AIA with providing Congress with a report on the effect of patenting on confirmatory genetic...more

PTO Releases Report on Confirmatory Genetic Diagnostic Testing

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

The Case Of GINA And The "Devious Defecator"

In a case dubbed “the mystery of the devious defecator” by a Georgia federal district judge, an Atlanta jury recently awarded a $2.2 million verdict against a company that requested DNA samples from two workers in an attempt...more

Sometimes You Just Cannot Make This Stuff Up

Warning: The following is true. Some readers may find the content disturbing. Reader discretion is advised. We have previously stated, although in somewhat tongue-in-cheek fashion, that labor and employment is the “TMZ”...more

Legal Alert - Updated FMLA Forms Issued by the DOL

This week, the U.S. Department of Labor (DOL) issued its new Family and Medical Leave Act (FMLA) forms, updating the previous forms which had expired on February 28, 2015. The new FMLA forms can be found on the DOL’s website....more

North Carolina General Assembly Week in Review

The Senate started its budget process this week, with a draft schedule being handed out to senators on Wednesday outlining precisely how the General Assembly can have a budget in place and approved by June 30. Distributed at...more

What Does Pharmacogenomics Have To Do With Product Liability? – Potentially Everything

Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On...more

Quest Diagnostics and Inserm Launch BRCA Data-Sharing Initiative

Last week, diagnostics services provider Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, announced the launch of BRCA Share, a new datashare initiative that will provide...more

Genetics-based medical treatment is not without problems

Many doctors and politicians are hailing genetics-based medical treatments as the future of medicine. With the personalized attention this medical approach allows, patients are expected to soon receive the best possible care...more

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

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