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…)

Canadian Province’s Plan to Begin Next-Generation Gene Sequencing of Newborns Shows Growing Role in Clinical Care for Genome-Guided Medicine

Utah-based Tute Genomics and UNIConnect will partner with Newborn Screening Ontario to uncover rare but treatable diseases in newborns

In the Canadian province of Ontario, next-generation gene sequencing will soon be part of newborn screening. This development is another confirmation for clinical laboratory managers and pathologists that genetic information from such diagnostic testing is contributing to improvements in clinical care.

Newborn Screening Ontario (NSO) is teaming up with Tute Genomics of Provo, Utah, and UNIConnect of Sandy, Utah, to enhance the province’s testing program for rare but treatable diseases in newborns.

The Ontario Ministry of Health and Long-Term Care is contracting with NSO to offer a next-generation sequencing testing panel and a multiple ligation-dependent probe amplification assay for the diagnostic confirmation of a variety of disorders. (more…)

Venter’s Research Team Creates an Artificial Cell and Reports That 32% of Genes Are Life-Essential but Contain Unknown Functions

Understanding the unknown functions of these genes may lead to the creation of new diagnostic tests for clinical laboratories and anatomic pathology groups

Once again, J. Craig Venter, PhD, is charting new ground in gene sequencing and genomic science. This time his research team has built upon the first synthetic cell they created in 2010 to build a more sophisticated synthetic cell. Their findings from this work may give pathologists and medical laboratory scientists new tools to diagnose disease.

Recently the research team at the J. Craig Venter Institute (JCVI) and Synthetic Genomics, Inc. (SGI) published their latest findings. Among the things they learned is that science still does not understand the functions of about a third of the genes required for their synthetic cells to function. (more…)

Recently published White Paper discusses the importance of clinical diagnostics laboratories having a capable system to handle molecular testing needs

The laboratory industry’s forward thinkers define molecular diagnostics and genetic testing as both the future of pathology and the #1 opportunity to add clinical value while earning appropriate reimbursement.

Personalized medicine and predictive medicine have become a reality. As molecular technology and personalized medicine increasingly becomes the default position for clinical diagnostics laboratories, these modalities place significant demands on laboratory information systems. Although hospitals and healthcare institutions often focus on an electronic medical records system that includes a laboratory information system (LIS), those LIS’s do not typically have the functionality needed to handle current molecular testing needs, or needs expected in the near future.

DarkDaily.com is pleased to offer a recently published White Paper that discusses the trends in increasing use of genetic and molecular testing, the growth of big data in healthcare, and the challenges facing laboratories in handling the complexities of personalized medicine. (more…)

Free Pharmacogenomics Test for Newborns Could Open Door to Wider Acceptance of Genomic Testing in Ways that Benefit Medical Laboratories

A hospital in Virginia now offers a genetic service to new parents that could impact clinical pathology laboratories if it develops into a trend

Here’s a first in the rapidly-developing field of pharmacogenomics testing. A hospital in Virginia announced that it would offer a free pharmacogenomics test to newborns. This is a development that will catch the attention of clinical pathologists and medical laboratory professionals at other hospitals across the country.

Inova Women’s Services at the Inova Woman’s Hospital on the Inova Fairfax Medical Campus in Falls Church, VA, has begun offering free MediMap tests to newborns. MediMap is a pharmacogenomics (PGx) test that looks for variations in seven genes that could indicate a child might process certain drugs differently than the majority of the population.

The program is an example of a well-known and often-used marketing tactic: “Buy X and get Y free!” Given the choice between a new free diaper bag and a free, painless test that, as Inova’s website states, “personalizes prescriptions to more effectively treat and manage illnesses in the future,” what new mother would choose the diaper bag? (more…)

3D Imaging of Cancer Cells Could Lead to Improved Ability of Pathologists and Radiologists to Plan Cancer Treatments and Monitor Cell Interactions

New technology from researchers at the University of Texas Southwestern Medical Center enables the ability to study cancer cells in their native microenvironments

Imaging research is one step closer to giving clinicians a way to do high-resolution scans of malignant cells in order to diagnose cancer and help identify useful therapies. If this technology were to prove successful in clinical studies, it might change how anatomic pathologists and radiologists diagnose and treat cancer.

Researchers at the University of Texas Southwestern Medical Center developed a way to create near-isotropic, high-resolution scans of cells within their microenvironments. The process involves utilizing a combination of two-photon Bessel beams and specialized filtering. (more…)

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