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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New Vaccine in Development at University of Buffalo Could Eradicate Pneumonia and Prevent the Deaths of Nearly One Million Children Under Five Worldwide Each Year

New vaccine has potential to reduce volume of clinical laboratory testing for bacterial and viral infections

By now, nearly all pathologists and clinical laboratory scientists acknowledge that advances in molecular diagnostics and genetic testing are contributing to significant improvements in patient care. Now comes news of a comparable breakthrough in another field of medicine with the potential to protect many individuals from pneumonia and similar infectious diseases.

A new way to develop vaccines made the news recently. Researchers at the University of Buffalo (UB) in New York have found a new way to reduce infections of specific and widespread Streptococcus pneumoniae (pneumococcus) diseases.

This cutting-edge pneumococcal vaccine allows Streptococcus pneumoniae to colonize and live inside the body as long as there is no risk to the host. When a threat is detected, the vaccine establishes an immune system response to annihilate the disease-causing bacteria. (more…)

Theranos CEO Elizabeth Holmes Presents Scientific Data to Clinical Laboratory Chemists and Pathologists at AACC in Philadelphia

Yesterday’s presentation by Holmes was made to an audience that was clearly skeptical, and she was careful to avoid discussions about her company’s many issues and federal investigations

DATELINE: PHILADELPHIA, PA.—Yesterday, Elizabeth Holmes, CEO of Theranos, Inc., took the stage at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo (AACC), the nation’s biggest clinical laboratory meeting, purportedly, for the first time ever, to deliver scientific data about her lab company’s diagnostic technologies. She also was there to answer questions from an expert panel before an attentive audience of clinical chemists and pathologists. A large number of journalists also were in attendance.

It may have escaped the notice of most of the audience—but not your intrepid editor—that the last song played over the PA system in the grand ballroom before Elizabeth Holmes was introduced and took the stage was “Sympathy for the Devil,” a big hit for The Rolling Stones in 1968. That song was an appropriate choice, since AACC’s invitation for Theranos to speak means the association is doing its own dance with the devil that some clinical chemists consider to be Theranos. (more…)

Secret Meeting Between Scientists and Thought Leaders at Harvard to Discuss Creating Synthetic Human Genome Sparks Controversy; Were Pathologists in Attendance?

The idea that human beings could be created without biological parents sounds like the stuff of science fiction, but it’s not, and the technology could be available in the not so distant future

It’s not known how many pathologists and clinical chemists were in attendance at a secret meeting that took place in Boston in May, which was organized to investigate the feasibility of building a synthetic human genome.

Nearly 150 scientists, lawyers, entrepreneurs, and ethicists met in a closed-door session at Harvard Medical School to discuss creating a synthetic human genome. Although this meeting was secret, people took notice. The possibility of using a synthetic genome to create human beings—without biological parents—understandably caused concern among the life science communities, the New York Times reported, and the apparent secrecy fueled speculation that ignited controversy, which spread rapidly. (more…)

Can Medical Laboratories Tell Patients There’s No Need for Overnight Fasting before a Cholesterol Test? Denmark’s Experience Says Answer is ‘Yes!’

Comparing results from more than 300,000 individuals, international experts recommend using non-fasting blood screening for most cholesterol and triglyceride tests

Every clinical laboratory offering cholesterol testing across the globe must deal with a common issue: because patients are told to fast overnight before giving a blood specimen, patient service centers (PSCs) and blood collection centers are overcrowded when they first open their doors in the morning. That’s because hungry patients want their sample collected so they then go eat something as soon as possible.

It has long been recognized that the overnight fasting requirement for collecting blood samples used in cholesterol testing is unpleasant for patients. It also adds cost to the healthcare system because labs must staff an adequate number of phlebotomists in their PSCs to handle the predictable early morning rush of hungry patients wanting to be done with this task. Meanwhile, in the afternoons, patient traffic in the same PSCs can dwindle to near nothing, leaving phlebotomists in those PSCs with little to do. (more…)

More Clinical Laboratories and Genetic Testing Companies Are Sharing Gene Sequencing Data That Involve Variations

The National Institute of Health’s ClinVar public database of genetic variation is demonstrating good accuracy, and a handful of clinical labs are learning to share and review this relatively small genetic database

In the analysis of genomic variants, data sharing is proving to be an important tool for researchers, scientists, pathologists, and clinical laboratory scientists.

Accessible databases like ClinVar, which was launched by the National Institute of Health (NIH) in 2013, have emerged to aggregate genetic sequencing with acceptable results. ClinVar exists to meet the needs of the medical genetics community. It collaborates with organizations to make pertinent genetic information available.

ClinVar is an archive of compiled data relating to genotype and phenotype variations among humans. Through this database, individuals can present and peruse submissions regarding variants found in patient samples.

ClinVar is averaging about 6,000 submissions per month by both commercial laboratory companies and reference labs. Major contributors to the database include: (more…)

When Screening for Esophageal and Gastrointestinal Cancer, Rice University’s Low-Cost Microendoscope Could Reduce Need to Send Biopsies to Pathologists

This low-cost solution opens new doors for low-resource regions and, in many cases, allows operators to rule out malignancy without the need for a pathologist to review biopsies

Rapid development of endoscopic technologies is bringing medical professionals closer to point-of-care pathology than ever before. The goal is to allow physicians to identify diseased or cancerous tissue in situ and reduce or eliminate the need to biopsy tissue for examination by surgical pathologists.

Researchers at Rice University in Houston are developing a high-resolution microendoscope (HRME) that offers the ability to view tissue at a subcellular level. This fiber optic probe would reduce the need to collect the biopsy that is typically sent to anatomic pathologists for analysis.

Measuring 1-mm in diameter, the probe works using the existing accessory channel of the endoscope. Touching it to the surface of the tissue provides real-time in vivo images to the technician at up to 12 frames per second on an accompanying tablet display. Images are enhanced using visual overlays and an algorithm that highlights the nuclei of cells within the field of view. The HRME system is battery powered and fits in a briefcase for easy transport. (more…)

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