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…)

New Medical Laboratory Test from Washington University School of Medicine Could One Day Replace the Popular PCR Assays Used by Many Pathologists

Called ‘ViroCap,’ this new diagnostic technology is able to discover more viruses in patient samples, as compared to PCR genome sequencing tests

It could be the ultimate multi-analysis medical laboratory test ever. Researchers at Washington University School of Medicine in St. Louis have developed a diagnostic test that they claim tests for any virus infecting people and animals.

The new test, called ViroCap, detects viruses that standard tests based on genome sequencing cannot, according to a university statement.

Viruses Make for a Popular Research Subject

Are virus tests going, well, viral? It was just a few weeks ago that Dark Daily reported on research at Howard Hughes Medical Institute (HHMI) aimed at unlocking virus detection beyond one pathogen at a time. (See Dark Daily, “Researchers at Howard Hughes Medical Institute Develop Blood Test That Reveals a Patient’s Viral History; Could Reduce Unnecessary Clinical Laboratory Testing,” December, 30, 2015.)

The HHMI research resulted in VirScan, an alternative to medical laboratory tests that test for specific viruses one at a time, and which can detect all diseases a patient has had over his or her lifetime, according to an HHMI news statement about the new technology. (more…)

NIH Funds Nine Anti-Microbial Resistance Diagnostic Projects to Deal with ‘Super Bugs’ and Give Clinical Laboratories New Diagnostic Tools to Improve Patient Care

Lab-on-a-chip technology could reduce the time needed to identify infection-causing bacteria and for physicians to prescribe correct antibiotics 

Pathology groups and medical laboratories may see their role in the patient-care process grow if researchers succeed in developing culture-independent diagnostic tools that quickly identify bacterial infections as well as pinpoint the antibiotics needed to treat them.

In the battle against antibiotic-resistant infections (AKA “super bugs”) the National Institutes of Health (NIH) is funding nine research projects aimed at thwarting the growing problem of life-threatening infections that no longer are controlled or killed by today’s arsenal of drugs.

Common Practices in Hospitals Leading to Super Bugs

Currently, when infections are suspected in hospitals or other settings where illness can quickly spread, samples are sent to a central medical laboratory where it may take up to three days to determine what germ is causing the infection. Because of that delay, physicians often prescribe broad-spectrum antibiotics based on a patient’s symptoms rather than lab test results, a practice that can lead to the growth of antibiotic-resistant microbes. (more…)

With Launch of RNAcentral Database, Pathologists Now Have Unprecedented Access to RNA Data

New public database gives clinical laboratory researchers a single, searchable source for non-coding RNA data, thus aiding development of new diagnostic assays

Clinical laboratories involved in next-generation gene sequencing have a new single searchable database for RNA. Experts say that this database should help research and development of medical laboratory tests for clinical purposes.

The launch of RNAcentral now provides RNA biologists and other researchers with an open resource that offers integrated access to a comprehensive, up-to-date set of non-coding RNA sequences. This is a first step to building a repository of information for non-coding RNAs that is similar to the Universal Protein Resource (UniProt) database for proteins.

RNAcentral is the brainchildof the RNAcentral Consortium, a large international collaboration of more than 30 expert databases that specialize in different types of non-coding RNAs. So far, 12 of these databases have been integrated into RNAcentral. The project is hosted by the European Bioinformatics Institute and funded by a United Kingdom Biotechnology and Biological Sciences Research Council (BBSRC) grant. (more…)

New High-Tech Mobile Medical Laboratories Deployed by the U.S. Navy and a European Consortium Use Genetic Analysis to Get Rapid Diagnosis of Ebola

These genetic tests cut time to answer from days to a few hours, reducing the risk of exposing non-infected patients and improving outcomes for Ebola patients

In response to the continuing outbreak of Ebola in the West African countries of Guinea, Liberia, and Sierra Leone, more attention has been given to medical laboratory testing in these countries, along with a rush to develop diagnostic tests that can detect Ebola faster and more accurately without the need for state-of-the art clinical laboratories that are uncommon in those nations.The lack of even limited basic services in the region, such as electricity, hinders any attempt to install modern diagnostic facilities and clinical laboratories essential to controlling and preventing further spread of the disease. Another issue is the lack of trained pathologists, Ph.Ds., and clinical laboratory scientists to staff such labs in those nations.

One solution to this challenge, however, is for developed nations to provide mobile medical laboratories and hospital facilities. Such resources have been contributed by the United States, Canada, and several European countries. (more…)

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