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
Sign In

University of Texas Researchers Develop New Techniques in Genetic Testing to Improve Clinical Laboratory Results through RNA

Innovative technological advances could potentially provide clinical laboratories, pathology groups, and medical researchers with improved methodologies for designing, performing, and analyzing lab tests that use genetic information

Researchers at the University of Texas at Austin (UT Austin) have developed an innovative new enzyme that promises to improve the methods and tools used by pathology groups and clinical laboratories when conducting genetic testing.

The enzyme enables the reproduction of large quantities of Ribonucleic acid (RNA) to be accurately duplicated. It also can perform reverse transcription and scrutinize itself while copying genetic information, which will enable both researchers and clinical laboratories to improve the accuracy of gene sequencing where RNA is involved.

The team published their findings in Science, the academic journal of The American Association for the Advancement of Science (AAAS) and filed for a provisional patent for the new sequence of the discovered enzyme. (more…)

University of Pennsylvania Researchers Develop $2 Zika Proof-of-Concept Test That Needs Neither Electricity Nor a Clinical Laboratory to Return Accurate Results

Using 3D printing and a chemical heat source, University of Pennsylvania researchers have created a proof-of-concept for an affordable Zika test that returns results in just 40 minutes

There’s a gap in Zika virus testing that researchers at the University of Pennsylvania hope to fill. That gap is a point-of-care test for the Zika virus that can produce a fast and accurate result, whether in developed nations or in developing countries that don’t have many state-of-the art clinical laboratories.

Although numerous Zika virus tests have earned Emergency Use Authorizations from the US Food and Drug Administration (FDA), gold standard detection is still limited to medical laboratories. To date, the FDA’s list of current and terminated Emergency Use Authorizations include no point-of-care options to help medical professionals quickly screen patients for Zika infection.

As noted by the Center for Disease Control and Prevention’s “Interim Guidance for Interpretation of Zika Antibody Test Results,” the antibodies that indicate Zika virus activity also share similarities with other flavivirus viruses. Of particular note is similarities with Dengue virus—a virus prevalent in many of the areas in which Zika is found. (more…)

New Fast, Inexpensive, Mobile Device Accurately Identifies Healthcare-Acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers

Use of these new technologies creates opportunities for clinical laboratories and pathologists to add more value when collaborating with physicians to advance patient care

Ongoing improvements in point-of-care testing are encouraging one major academic medical center to apply this mode of testing to the diagnosis of hospital-acquired infections (HAIs). This development should be of interest to clinical laboratory professionals and pathologists, since it has the potential to create a different way to identify patients with HAIs than medical lab tests done in the central laboratory.

Massachusetts General Hospital (MGH), Harvard Medical School’s (HMS’) largest teaching hospital, has developed a prototype diagnostic system that works with doctors’ smartphones or mobile computers. The hand-held system can identify pathogens responsible for specific healthcare-acquired infections (HAIs) at the point of care within two hours, according to an MGH statement.

The researchers noted that 600,000 patients develop HAIs each year, 10% of which die, and that costs related to HAIs can reach $100 to $150 billion per year. However, as Dark Daily reported, the Centers for Medicare and Medicaid Services (CMS) does not reimburse hospitals for certain HAIs. (See Dark Daily, Consumer Reports Ranks Smaller and Non-Teaching Hospitals Highest in Infection Prevention,” October, 30, 2015.) Thus, the critical need to identify from where the infection originated, which generates a significant proportion of samples tested at the clinical laboratories of the nation’s hospitals and health systems.

Therefore, pathologists and medical laboratory scientists will understand that shifting some of that specimen volume to point-of-care testing will change the overall economics of hospital laboratories.

Smartphone-based Genetic Test for HIAs

The MGH research team created a way to do accurate genetic testing in a simple device powered by a system they call Polarization Anisotropy Diagnostics (PAD). The system measures changes in fluorescence anisotropy through a detection probe’s recognition of bacterial nucleic acid, reported Medscape Medical News. More than 35 probes for detecting bacterial species and virulence factors are available.

Optical test cubes are placed on an electronic base station that transmits data to a smartphone or computer, where results are displayed. “In a pilot clinical test, PAD accuracy was comparable to that of bacterial culture. In contrast to the culture, the PAD assay was fast (under two hours), multiplexed, and cost effective (under $2 per assay), wrote the MGH researchers in the journal Science Advances. (more…)

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…)

;