News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Patent Dispute over CRISPR Gene-Editing Technology May Determine Who Will Be Paid Licensing Royalties by Medical Laboratories

U.S. Patent and Trademark Office will hold hearings to determine whether University of California Berkeley, or Broad Institute of Harvard and MIT, should receive patents for new genomic engineering technique

In the race to master gene-editing in ways that will advance genetic medicine and patient care, one of the hottest technologies is CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats. But now a patent fight has the potential to complicate how pathologists and other scientists use this exciting technology.

This dispute over the CRISPR patent—a tool that has been hailed as one of the biggest biotech breakthroughs of the decade—will likely be settled in the coming months by the United States Patent and Trademark Office (USPTO).

The USPTO will be reviewing key patents awarded for what is called CRISPR/Cas9. The technology is already generating novel therapies for diseases, which should create new opportunities for pathologists and medical laboratories. (more…)

Researchers at University of Rhode Island Unveil Lab-on-Paper Test Capable of Multireagent Diagnostics: Could Enable ‘Diagnostics Without the Lab’ say Developers

New diagnostic capabilities could enable clinical laboratories to obtain multiple outcomes on single fluidic strip tests

Researchers at the University of Rhode Island (URI) have developed a paper-based microfluidic valve technology that some claim may revolutionize existing lateral-flow tests. There is the potential for this innovation to eventually enable pathology groups and medical laboratories to conduct a wide variety of complex medical diagnostics on single fluidic test strips, such as those used to diagnose pregnancy and strep throat, according to a university statement.

Testing Multiple Biomarkers Using a Single Test Strip

Fluidic test strips commonly in use today are generally capable of rendering only one result. However, by combining their new paper-based valve platform with standards strip tests, the URI research team has produced strip tests capable of answering more challenging medical questions.

The evolution of the new technology, dubbed “Lab-on-Paper,” follows the development of the team’s earlier “lab-on-a-chip” device, which the researchers began developing back in 2005. (more…)

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…)

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