News
Pathologists and physicians in UK comment on how shortage of medical laboratory professionals could soon delay essential diagnostic, therapeutic testing
In the United Kingdom, pathologists and other physicians are going public with their concerns that a growing shortage of pathologists and medical laboratory scientists will soon contribute to delays in performing the lab tests needed to diagnose patients and identify which therapies will work best for them.
A 2016 report from Cancer Research UK, "Testing Times to Come? An Evaluation of Pathology Capacity Across the UK," predicts a critical shortage in laboratory staffing within the next decade. Data on Provider-based Cancer Waiting Times for August 2016 from National Health Service England shows that 17.2% of patients with an urgent referral for suspected cancer fail to start treatment within two months of the referral.
Both the Royal College of Pathologists and the Royal College of Physicians have petitioned UK government leaders to infuse funding for medical training programs to help slow the speed at which their current diagnostic facilities and medical infrastructure are being overwhelmed. In a letter targeted to the Minister, the Royal College of Physicians wrote, "… investment levels are not sufficient to meet current or future patient needs. As a result, in spite of rapid advances in clinical care, services are often too paralyzed by spiraling demand to transform and modernize." In a response, the Royal College of Pathologists (RCPath), highlights how staffing shortages and shifting regulations in other specialties are further increasing the impact of shortages on medical laboratories and histopathology labs.
SpaceX is about to send a lethal superbug into orbit
SpaceX launched a lethal, antibiotic-resistant superbug into orbit (Feb 14), to live its days in the microgravity environment of the International Space Station. The NASA-funded study will see colonies of MRSA (Methicillin-resistant Staphylococcus aureus) cultivated in the US National Laboratory on the Space Station. Nanobiosym developed a device known as Gene-RADAR and will be used on this space mission - the world's first mobile scanner that enables real-time diagnosis of any disease, at a tenth of the cost of similar diagnostic tests. From that, Anita Goel and her team will develop models that predict how the antibiotic-resistant pathogen will mutate on Earth in the coming years, giving drug developers a chance to pre-empt its next defensive moves. "[This] will lead to next generation antibiotics that are more precisely tailored to stop the spread of the world's most dangerous pathogens," says Goel, lead researcher and CEO Nanobiosym.
A 2000 experiment found that after 40 days aboard a Russian space station mutation rates for a cloned bacterial gene inserted into yeast were up to three times higher than the control group back on Earth. Another study from 1999 found that certain strains of E. coli had high mutation frequencies after a trip into space, but the types and frequencies varied widely depending on their conditions. If Goel's hunch is right, and space really does put MRSA into overdrive, it'll basically be like seeing all of your opponent's moves in advance when you're playing a game of chess. So instead of waiting for MRSA to develop a new kind of defence in response to current medications before we respond with a new kind of treatment, we could 'fast-forward' this process in space, and come out with a model for the next few decades of antibiotic resistance.
Leadership
Reclaiming the clinical conversation: A challenge for the laboratory
Remember back to where you used to be, shoulder to shoulder with the clinicians taking care of the patients and engaged in the clinical dialogue. The lab was more than just a sophisticated machine accepting questions and returning answers. How do we get back the value we lost?
There is a clear way to start: become engaged again with the care team and project your knowledge past the conventional confines of the lab report. That report can be seen as just the conversation starter, not the final product of your work. After all, gone are the days when clinicians can effectively consume and utilize a laboratory test menu, both on the ordering and the resulting side. They are having enough trouble just keeping their heads above water with the rapidly changing medical knowledge in their fields and the added pressure and noise of the modern practice of medicine. They want to talk with you!
You have to be proactive, stand up, and project your voice for this to work. Simply being good and showing up to do the work is not enough. It is less about what the data is (we know and expect it to be correct and timely), and it is more about what we do with that data. Your customers (clinicians) need the laboratory’s help more than ever with complex data and results. It is time for the laboratory to stand up and speak.
Read this article and see how language and dialogue can help change our profession.
Clinical Chemistry
Hair analysis may help diagnose Cushing Syndrome, NIH researchers report
Analyzing a hair sample may help with the diagnosis of Cushing Syndrome (CS), a rare and potentially fatal disorder in which the body overproduces the stress hormone cortisol. It is often difficult and time-consuming to diagnose, requiring 24 hours to analyze blood and urine tests, brain imaging tests, and tissue samples from sinuses at the base of the skull. Published in Endocrine: International Journal of Basic and Clinical Endocrinology, researchers found that measuring cortisol levels in hair samples tracked closely with standard techniques for diagnosing CS. "Our results are encouraging," said Dr. Mihail Zilbermint, an endocrinologist at Eunice Kennedy Shriver National Institute of Child Health and Human Development. "We are hopeful that hair analysis may ultimately prove useful as a less-invasive screening test for Cushing Syndrome or in helping to confirm the diagnosis."
Given the rarity of the disease, only 30 CS patients and 6 patients who did not have the condition were enrolled in the study. The study participants provided hair samples divided into three equal segments. Researchers observed that the hair segments closest to the scalp had the most cortisol. Compared to hair segments furthest away from the scalp, the cortisol content of the proximal segments correlated closely with tests for cortisol levels in the urine and in blood taken at night. For most people, cortisol levels decrease at night. An elevated nighttime cortisol level in the blood is considered to be a key indicator of CS.
Related Article: Introducing "Armadillo Syndrome"
Hematology
CWRU researchers secure $2 million NIH grant to test portable sickle cell monitor
Researchers at Case Western Reserve University will use a $2 million grant from the National Institutes of Health to develop and test a small, portable blood-adhesion monitor for sickle cell disease patients.
Sickle cell patients suffer from vaso-occlusive crises when abnormal sticky blood cells clog blood vessels. Although the proximate causes of this are not well understood, hemoglobin molecules link into long chains inside red blood cells, stiffening the cells and changing cell shape from a donut without a hole to a crescent. Simultaneously, adhesive proteins form on the surface of the cells. These changes hamper the flow of the cells in the bloodstream and increase blood clogged vessels. Early test versions have proven capable of determining whether cells are sticky and the level of stickiness, "but we don't know if this information will make a difference in patients' lives or in how the disease is managed," said Umut Gurkan, assistant professor of mechanical and aerospace engineering and project leader. Gurkan and colleagues believe the stickiness of a patient's blood cells reflects disease severity and may be used to predict vaso-occlusive crises. If a prodrome can be identified, strategies can be developed to block the generation of the vaso-occlusive episode.
Transfusion Medicine
New test predicts graft-versus-host disease outcome and survival
It’s tragically ironic that in medicine, sometimes the cure is almost as harmful as the poison. This is the case for bone marrow transplant, which could have the nearly same chance of saving a patient as it does harming the patient.
To minimize the risks and guide the decision process, scientists at the Mount Sinai School of Medicine developed an algorithm that’s smart enough to predict the outcome of this procedure for each patient. With the use of 1,300 samples from 11 hospitals, the team found that presence of two key proteins predicted the likelihood of a patient developing lethal GVHD.
Dubbed the "MAGIC algorithm" (Mount Sinai Acute GVHD International Consortium algorithm), this tool measures the concentrations of the proteins ST2 and REG3A. Abnormal presence of these proteins can signal the oncoming of graft-versus-host disease (GVHD) weeks before symptoms occur. In GVHD, the patient’s body recognizes the transplanted bone marrow as foreign and begins to attack, causing life-threatening complications. Knowing if this scenario will play out should give doctors more time to react and possibly prevent full-blown GVHD cases.
Anatomic Pathology
British medical laboratory test for early screening of lung cancer shows promising interim results in large trial
Encouraging preliminary results from a 12,000-person clinical trial into the effectiveness of a non-invasive medical laboratory blood test for the early detection of lung cancer could signal an advance that leads to creation of similar anatomic pathology screening tests for the early detection of other cancers. Interim results of a study using the potentially life-saving blood test EarlyCDT-Lung were presented at the International Association for the Study of Lung Cancer’s 17th World Conference on Lung Cancer. Initial results from the trial indicated the blood test can detect lung cancer potentially up to five years before symptoms develop and traditional scans show damage.
The National Health Service Scotland Early Lung Cancer Detection Study (ECLS) is the largest randomized trial for the early detection of lung cancer using biomarkers ever conducted, according to Oncimmune, an early-cancer detection company in the UK that has developed and is commercializing the EarlyCDT platform technology. EarlyCDT-Lung measures a panel of seven autoantibodies associated specifically with lung cancer.
Interim results that showed nearly one in 10 (9.8%) participants of the 6,000-person test group who received the blood test had results indicating antibodies present. Those with a positive test result were then investigated further with a chest X-ray and serial CT scans to look for signs of cancer. Sixteen lung cancers have been detected, 12 (75%) of which are at an early stage. "The results continue to be very encouraging and suggest it could be possible to detect early stage lung cancers sooner than with current methods," Frank Sullivan, PhD, research professor at the University of Toronto. "We look forward to completing the study and presenting full results, including the control group, after the full follow-up period."
Cytology
HPV vs. Pap test for cervical cancer screening: Strong evidence calls for new protocols, say experts
For many years, cytology has been the established method used for annual cervical cancer screening. Evidence now shows that sexually transmitted human papillomavirus (HPV) infection is almost always responsible for cases of cervical cancer with two types most responsible. Many members of the health care community are now calling for a shift in screening procedures to reflect our improved understanding of cervical cancer development.
In a special issue of Preventive Medicine, experts look at the emerging evidence that HPV screening may be a better way than Pap tests for doctors to screen for cervical cancer. As Guest Editor for the special issue, Dr. Mark Schiffman, senior investigator in the Clinical Genetics Branch at the National Cancer Institute, wrote, "HPV testing is coming and the role of cytology will be reduced; however, this collection of evidence summaries, guidelines, and editorials aims to illustrate the variety of ways the changeover will occur globally. More broadly, this special issue illustrates the importance and limits of epidemiology as the 'basic science of public health.' The conclusion is that given an established epidemiologic set of scientific facts and validated prevention tools, real-life concerns that vary by region will determine which public health strategies are used."
Dr. Schiffman's straightforward editorial touches on the potentially controversial elements of HPV testing as a primary screening method for cervical cancer. "It turns out that detailed implementation of HPV primary screening to replace cytology reveals many choices reliant on value judgments and not risk assessment, particularly when resources are limited," said Dr. Schiffman. "Controversial areas include acceptable costs and effort, choices of safety and action thresholds, and the role of the clinician in the integration of test data vs apps and guidelines."
Research
Parkinson's disease diagnosis could be aided with blood test
Swedish researchers say a simple blood test examining for a biomarker is effective at differentiating symptoms of Parkinson's disease from similar disorders, but it isn't ready for clinical use. Published in the journal Neurology, Dr. Oskar Hansson of Lund University examined 504 people in three groups. The study included 3 independent prospective cohorts: the Lund (n = 278) and London (n = 117) cohorts, comprising healthy controls and patients with PD, progressive supranuclear palsy (PSP), corticobasal syndrome (CBS), and multiple system atrophy (MSA), as well as an early disease cohort (n = 109) of patients with PD, PSP, MSA, or CBS with disease duration ≤3 years.
Blood NfL (neurofilament light chain) concentration was measured using an ultrasensitive single molecule array (Simoa) method, and the diagnostic accuracy to distinguish PD from APD was investigated. "The results of the present study strongly indicate that NfL, when measured in blood, can be used to distinguish between patients with Parkinson's disease and patients with progressive supranuclear palsy multiple system atrophy and corticobasal degeneration with high diagnostic accuracy," the study's authors said. The results also seem highly reliable as described in a journal editorial. Most patients with Parkinson's showed NfL levels in the normal range. "We still lack an easily accessible disease-specific diagnostic biomarker for the most common movement disorder," according to the editorial.
Breaking research published in AACC's Clinical Chemistry journal could help to combat rise in drivers impaired by edible marijuana consumption
Though marijuana edibles are becoming increasingly common, scant information exists on how to test drivers for impairment following their consumption. For the first time, research published in Clinical Chemistry evaluates the performance of roadside saliva tests for tetrahydrocannabinol (THC) following consumption of edibles, showing that lower THC cutoff points are needed for these tests to effectively detect marijuana ingestion.
In this study, a team of researchers from the National Institute on Drug Abuse, set out to fill this critical gap in roadside marijuana testing knowledge. The researchers gave occasional and frequent marijuana smokers brownies laced with 50.6 mg of THC. Over the course of 48 hours, the researchers then collected saliva and blood samples from the participants at several time-points. The saliva samples were analyzed using two roadside screening devices, the Draeger DrugTest 5000 (DT5000) and Alere DDS2 (DDS2); these devices use THC cutoff points of 5 µg/L and 25 µg/L, respectively, to determine if someone is positive or negative for marijuana use. Through comparing the roadside and LC-MS/MS results, the researchers determined that confirmation cutoffs for THC of ≥1 µg/L and ≥2 µg/L led to the greatest number of true positive results, i.e. individuals who tested positive for marijuana both through the initial screening and through confirmation testing. This shows that on-site saliva testing devices can successfully detect THC after marijuana ingestion, but that these devices need lower cutoff points to optimize their efficacy.
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