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…)

New DNA Analysis Laboratory from Bento Bioworks Enables Anyone to Perform DNA Testing, Whether at Home or in Clinical Pathology Laboratories

Blood genotyping is one type of DNA test this miniature lab can perform as entrepreneurs work to take DNA testing out of medical laboratories and into other settings

It had to happen! There’s now a product designed to allow individuals to perform “do-it-yourself” DNA testing. Pathologists and clinical laboratory managers will be interested to learn that—for less than $800—they can acquire their own home set-up, which includes a PCR thermocycler, a centrifuge, a gel electrophoresis box, and a power supply with blue LED transillumination.

This new, compact, deoxyribonucleic acid (DNA) analysis product was developed to give individuals who want to work with DNA a fun and easy way to explore their genetic make-up.

It was developed by Bento Bioworks, a company based in London, England, and is described as a do-it-yourself DNA analysis kit called Bento Lab. The device is about the size of a laptop computer and may be used anywhere to conduct a variety of DNA experiments.

Bento Lab allows people to conduct simple DNA tests from samples obtained from saliva or hair follicles. Animal tissue, food, and drink samples may also be evaluated with the unit.

To perform an experiment, the user simply places a sample into a centrifuge located in the middle of the device. Bento Lab then extracts the DNA for analysis and a thermocycler targets a specific portion of the DNA and copies it. A gel unit then portrays the DNA to enable the user to interpret the results. (more…)

How Smart Clinical Laboratories and Genetic Testing Labs Are Collecting More Revenue by Pricing Tests to Meet the Expectations of Patients

By rethinking how their medical labs relate to health insurers, physicians, and patients, a handful of progressive lab companies are enjoying increased revenue while also lifting patient and payer satisfaction

There is widespread agreement across the clinical laboratory industry that it is becoming ever more difficult to have health plans reimburse claims for common tests, molecular assays, and genetic tests in a reliable and consistent manner. Many lab companies report that they are experiencing high rates of denied claims. Moreover—even for claims reimbursed by payers—the amount paid will vary on claims for the same type of lab test.

“Essentially, on this point, the consistent theme we hear from many lab companies—particularly those labs with a menu of proprietary, specialized molecular and genetic tests—is that it is now almost a crap-shoot to submit lab test claims to many payers and see timely and predictable reimbursement for those claims,” stated Robert L. Michel, Editor-In-Chief of Dark Daily’s sister publication, The Dark Report. “One could say that, today, the function of billing patients and payers for clinical lab testing has become financial quicksand for most labs. By following traditional coding, billing, and collection practices, in today’s healthcare market, they find themselves sinking steadily deeper in this financial quicksand.” (more…)

Johnson & Johnson Investing to Learn How to Predict or Prevent Disease; Studies Could Lead to Clinical Laboratory Tests that Detect Disease Earlier and More Accurately

COPD and gestational diabetes research are the subject of two new projects aimed at intercepting diseases prior to onset and identifying preventive treatments

Can new insights into the human genome make it possible to diagnose disease much earlier—even before symptoms can be observed? Multiple research programs are targeting this possibility. One example is being conducted by Johnson & Johnson (J&J). The American multinational medical-device company wants to leverage recent developments in genetics, data analysis, and its worldwide partnerships, in an attempt to answer two profound questions:

• Can the earliest signals of disease be identified; and

• What treatments will assist researchers who are trying to prevent diseases?

To pursue these two goals, Johnson & Johnson (NYSE: JNJ) is expanding its existing research project into disease prediction and prevention, which currently involves 24 global partners, according to an Associated Press March story. (more…)

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