Federal Court Issues Ruling in the Gene Patent Case Involving Myriad Genetics and the Association of Molecular Pathology

Many in the clinical laboratory and pathology industry will hold their breath as Myriad seeks to derail gene patent challenge by attacking standing of sole remaining plaintiff

There’s news regarding the widely-watched federal lawsuit that challenges the gene patents owned by Myriad Genetics  (NASDAQ:MYGN). On September 13, a Federal Circuit panel denied the ACLU’s Petition for Rehearing in this case. Clinical laboratory managers and pathologists following this controversial lawsuit will be interested in this latest development.

Since early this year, there have ongoing legal maneuvers by both sides in this case, which is officially titled: Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office et al. 09-civ-4515. It is a high profile lawsuit because of its potential to establish important new legal precedents in how and when genes may be patented. (more…)

HHS and CMS Team Up to Propose New Rule to Give Patients Direct Access to their Clinical Pathology Laboratory Test Results

Draft language of new rule would change existing requirements on access to medical laboratory test results as defined in CLIA and HIPAA laws

Big changes lie ahead in how clinical laboratories and pathology groups must give patients access to their medical laboratory test results. Last week, federal agencies published a draft rule that specifies how patients or their authorized representatives are to be given direct access to their medical laboratory test results.

This draft rule was made public on September 12 by the Department of Health and Human Services (HHS), along with the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the HHS Office for Civil Rights. Two days later, on September 14, the proposed rule was published in the Federal Register. There will be a 60-day period from the date of this publication for public comment on the proposed rule. (more…)