‘Care Studio’ is designed to give physicians a ‘single, centralized view’ of patients’ records that are spread among multiple disparate databases within a healthcare system
Lack of interoperability between electronic health records (EHRs) has been a thorn in the side of healthcare providers—including clinical laboratorians and pathologists—who have to search multiple healthcare organizations’ databases to pull together medical records on individual patients. Google Health claims it may have the answer to the longstanding issue of siloed patient records.
Google Health and St. Louis-based Ascension, one of the largest healthcare systems in the US, have announced the clinical pilot of their new Care Studio platform. The software tool, according to the Care Studio website, “leverages Google’s expertise in organizing information to help clinicians find health record information faster.
“The tool’s Clinical Search feature,” Google Health continues, “enables nurses and doctors to simply type what they’re looking for and quickly find the specific information requested—which might otherwise require significant time and effort to uncover.”
Essentially, Care Studio complements existing EHR systems and enables healthcare providers to quickly search and organize previously siloed patient healthcare data stored on multiple EHRs within a health system. If successful, such a tool would clearly help streamline physicians’ workflows and shave hours off their daily patient research.
According to Google Health, Care Studio is a cross-platform EHR tool that gives clinicians a “single, centralized view that brings forward a patient’s hospital visits, outpatient events, laboratory tests, medications and treatments, and progress notes.”
Gathered data then can be visualized in tables, graphs, and other formats.
According to Medical Device Network, Google and Ascension originally introduced Care Studio to a small number of providers at Ascension’s Nashville and Jacksonville, Fla., locations. They are now expanding the pilot to more nurses and physicians working in clinical settings.
In a blog post, Eduardo Conrado, Executive Vice President, Strategy and Innovation at Ascension, wrote, “In current EHR systems, clinical information too often is buried in siloed records scattered across hospitals, clinics, urgent care centers, pharmacies, physician offices, labs, and other sites of care, making it challenging for physicians and caregivers to efficiently deliver coordinated and precise care.
“When information is finally retrieved from these disparate EHR systems,” he added, “it is usually poorly organized and fragmented. Most clinicians work in an environment where data is incomplete, inaccessible, and delivered in disjointed bursts of information without context.”
COVID-19 Accelerates Need for Improvements in Data Access
Conrado notes that the ability for clinicians to quickly retrieve and organize a patient’s complete clinical history is “the essence of delivering effective and efficient care.” He wrote that the “once-in-a-generation” COVID-19 pandemic has accelerated the need for improvements in public health infrastructure, health technology services, and care delivery models and “reinforced the significant impact that complex and often confusing EHR systems, and the fragmentation of patient health data, have on delivering effective care.”
While the collaboration between Ascension and Google began in 2018, Conrado said “remarkable” progress was made on Care Studio this past year.
Conrado did not state how long the clinical pilot of Care Studio would last but emphasized that the technology will be enhanced with additional features and improvements based on feedback from pilot clinicians. Ultimately, the clinical search tool will be made available to all caregivers across Ascension’s 2,600 sites of care, including 145 hospitals and more than 40 senior living facilities in 19 states and the District of Columbia.
Clinical laboratories should welcome this development. Any software tool or information technology that allows clinical laboratory test data to move across different EHRs will help interoperability.
VCU scientists used the technique to measure mutations associated with acute myeloid leukemia, potentially offering an attractive alternative to DNA sequencing
More accurate but less-costly cancer diagnostics are the Holy Grail of cancer research. Now, research scientists at Virginia Commonwealth University (VCU) say they have developed a clinical laboratory diagnostic technique that could be far cheaper and more capable than standard DNA sequencing in diagnosing some diseases. Their method combines digital polymerase chain reaction (dPCR) technology with high-speed atomic force microscopy (HS-AFM) to generate nanoscale-resolution images of DNA.
The technique allows the researchers to measure polymorphisms—variations in gene lengths—that are associated with many cancers and neurological diseases. The VCU scientists say the new technique costs less than $1 to scan each dPCR reaction.
“We chose to focus on FLT3 mutations because they are difficult to [diagnose], and the standard assay is limited in capability,” said physicist Jason Reed, PhD, Assistant Professor in the Virginia Commonwealth University Department of Physics, in a VCU press release.
Reed is an expert in nanotechnology as it relates to biology and medicine. He led a team that included other researchers in VCU’s physics department as well as physicians from VCU Massey Cancer Center and the Department of Internal Medicine at VCU School of Medicine.
Validating the Clinical Laboratory Test
The physicists worked with two VCU physicians—hematologist/oncologist Amir Toor, MD, and hematopathologist Alden Chesney, MD—to compare the imaging technique to the LeukoStrat CDx FLT3 Mutation Assay, which they described as the “current gold standard test” for diagnosing FLT3 gene mutations.
The researchers said their technique matched the results of the LeukoStrat test in diagnosing the mutations. But unlike that test, the new technique also can measure variant allele frequency (VAL). This “can show whether the mutation is inherited and allows the detection of mutations that could potentially be missed by the current test,” states the VCU press release.
“We plan to continue developing and testing this technology in other diseases involving DNA structural mutations,” Reed said. “We hope it can be a powerful and cost-effective tool for doctors around the world treating cancer and other devastating diseases driven by DNA mutations.”
“In our approach we first used digital PCR, in which a mixed sample is diluted to less than one target molecule per aliquot and the aliquots are amplified to yield homogeneous populations of amplicons,” he said. “Then, we deposited each population onto an atomically-flat partitioned surface.”
The VCU researchers “scanned each partition with high-speed atomic force microscopy, in which an extremely sharp tip is rastered across the surface, returning a 3D map of the surface with nanoscale resolution,” he said. “We wrote code that traced the length of each imaged DNA molecule, and the distribution of lengths was used to determine whether the aliquot was a wild type [unmutated] or variant.”
In Diagnostics World, Reed said the method “doesn’t really have any more complexity than a PCR assay itself. It can easily be done by most lab technicians.”
Earlier Research
A VCU press release from 2017 noted that Reed’s research team had developed technology that uses optical lasers (similar to those in a DVD player) to accelerate the scanning. The researchers previously published a study about the technique in Nature Communications, and a patent is currently pending.
“DNA sequencing is a powerful tool, but it is still quite expensive and has several technological and functional limitations that make it difficult to map large areas of the genome efficiently and accurately,” Reed said in the 2017 VCU press release. “Our approach bridges the gap between DNA sequencing and other physical mapping techniques that lack resolution. It can be used as a stand-alone method or it can complement DNA sequencing by reducing complexity and error when piecing together the small bits of genome analyzed during the sequencing process.”
Using CRISPR technology, the team also developed what they described as a “chemical barcoding solution,” placing markers on DNA molecules to identify genetic mutations.
New DNA Clinical Laboratory Testing?
Cancer diagnostics are constantly evolving and improving. It is not clear how long it will be before VCU’s new technique will reach clinical laboratories that perform DNA testing, if at all. But VCU’s new technique is intriguing, and should it prove viable for clinical diagnostic use it could revolutionize cancer diagnosis. It is a development worth watching.
Painless technology could one day replace some phlebotomy blood draws as the go-to specimen-collection method for clinical laboratory testing and health monitoring
Clinical laboratories have long sought a non-invasive way to do useful medical laboratory testing without the need for either a venipuncture or a needle stick. Now engineers at the McKelvey School of Engineering at Washington University in St. Louis in Missouri have developed a disposable microneedle patch that one day could be a painless alternative to some blood draws for diagnostics tests and health monitoring.
The technology uses an easy-to-administer low-cost patch that can be applied to the skin like an adhesive bandage. The patch is virtually painless because the microneedles are too small to reach nerve receptors. Another unique aspect to this innovative approach to collecting a specimen for diagnostic testing is that the Washington University in St. Louis (WashU) research team designed the microneedle patch to include plasmonic-fluor. These are ultrabright gold nanolabels that light up target protein biomarkers and can make the biomarkers up to 1,400 times brighter at low concentrations, compared to traditional fluorescent labels.
The patch, states a WashU news release, “… can be applied to the skin, capture a biomarker of interest and, thanks to its unprecedented sensitivity, allow clinicians to detect its presence.”
The technology is low cost, easy for clinicians or patients themselves to use, and could eliminate the need for a trip to patient service center where a phlebotomist would draw blood for clinical laboratory testing, the news release states.
“We used the microneedle patch in mice for minimally invasive evaluation of the efficiency of a cocaine vaccine, for longitudinal monitoring of the levels of inflammatory biomarkers, and for efficient sampling of the calvarial periosteum [a skull membrane]—a challenging site for biomarker detection—and the quantification of its levels of the matricellular protein periostin, which cannot be accurately inferred from blood or other systemic biofluids,” the researchers wrote. “Microneedle patches for the minimally invasive collection and analysis of biomarkers in interstitial fluid might facilitate point-of-care diagnostics and longitudinal monitoring.”
Mark Prausnitz, PhD, Regents’ Professor, J. Erskine Love Jr. Chair in Chemical and Biomolecular Engineering, and Director of the Center for Drug Design, Development, and Delivery at Georgia Tech, told WIRED, “Blood is a tiny fraction of the fluid in our body. Other fluids should have something useful—it’s just hard to get those fluids.”
“Previously, concentrations of a biomarker had to be on the order of a few micrograms per milliliter of fluid,” said Zheyu (Ryan) Wang, a PhD candidate in Srikanth Singamaneni’s lab at McKelvey School of Engineering and a lead author of the paper, in the WashU news release. By using plasmonic-fluor, researchers were able to detect biomarkers on the order of picograms per milliliter—one millionth of the concentration.
“That’s orders of magnitude more sensitive,” Wang said.
Can Microneedles Be Used as a Diagnostic Tool?
As reported in WIRED, the polystyrene patch developed by Srikanth Singamaneni’s lab at McKelvey School of Engineering removes interstitial fluid from the skin and turns the needles into “biomarker traps” by coating them with antibodies known to bind to specific proteins, such as Interleukin 6 (IL-6). Once the microneedles are mixed with plasmonic-fluor, the patch will glow if the IL-6 biomarkers are present.
The development of such a highly sensitive biomarker-detection method means skin becomes a potential pathway for using microneedles to diagnose conditions, such as myocardial infarction or to measure COVID-19 antibodies in vaccinated persons.
“Now we can actually use this tool to understand what’s going on with interstitial fluid, and how we’re going to be able to use it to answer healthcare-related or medical problems,” Maral Mousavi, PhD, Assistant Professor of Biomedical Engineering, Viterbi School of Engineering at the University of Southern California, told WIRED. “I think it has the potential to be that kind of a game changer.”
Because the WashU study is a proof-of-concept in mice, it may be many years before this technology finds its way to clinical application. Many skin biomarkers will need to be verified for direct links to disease before microneedle patches will be of practical use to clinicians for diagnostics. However, microneedle patch technology has already proven viable for the collection of blood.
In 2017, Massachusetts-based Seventh Sense Biosystems (7SBio) received 510(k) clearance for a new microneedle blood collection device. Called TAP, the device is placed on the upper arm and blood collection starts with a press of a button. The process takes two to three minutes.
Initially, the FDA clearance permitted only healthcare workers to use the device “to collect capillary blood for hemoglobin A1c (HbA1c) testing, which is routinely used to monitor blood sugar levels in diabetic or pre-diabetic patients,” a Flagship Pioneering news release noted.
Then, in 2019, the FDA extended its authorization “to include blood collection by laypersons. Regulators are also allowing the device to be used ‘at-home’ for wellness testing,” a 7SBio news release stated. This opened the door for a microneedle device to be used for home care blood collection.
“No one likes getting blood drawn, but blood is the single-most important source of medical information in healthcare today, with about 90% of all diagnostic information coming from blood and its components,” Howard Weisman, former CEO of 7SBio and current CEO of PaxMedica, a clinical-stage biopharmaceutical company, said in the Flagship Pioneering news release. “TAP has the potential to transform blood collection from an inconvenient, stressful, and painful experience to one people can do themselves anywhere, making health monitoring much easier for both healthcare professionals and patients.”
As microneedle technology continues to evolve, clinical laboratories should expect patches to be used in a growing number of drug delivery systems and diagnostic tests. But further research will be needed to determine whether interstitial fluid can provide an alternate pathway for diagnosing disease.
The palm-sized device could one day be engineered to track down explosives and gas leaks or could even be used by medical laboratories to detect disease
Here’s a technology breakthrough with many implications for diagnostics and clinical laboratory testing. Researchers at the at the University of Washington (UW) are pushing the envelope on what can be achieved by combining technology with biology. They developed “Smellicopter,” a flying drone that uses a living moth antenna to hunt for odors.
According to their published study, the UW scientists believe an odor-guided drone could “reduce human hazard and drastically improve performance on tasks such as locating disaster survivors, hazardous gas leaks, incipient fires or explosives.”
“Nature really blows our human-made odor sensors out of the water,” lead author Melanie Anderson, a UW doctoral student in mechanical engineering, told UW News. “By using an actual moth antenna with Smellicopter, we’re able to get the best of both worlds: the sensitivity of a biological organism on a robotic platform where we can control its motion.”
The researchers believe their Smellicopter is the first odor-sensing flying biohybrid robot system to incorporate a live moth antenna that capitalizes on the insect’s excellent odor-detecting and odor-locating abilities.
In their paper, titled, “A Bio-Hybrid Odor-Guided Autonomous Palm-Sized Air Vehicle,” published in the IOPscience journal Bioinspiration and Biomimetics, the researchers wrote, “Biohybrid systems integrate living materials with synthetic devices, exploiting their respective advantages to solve challenging engineering problems. … Our robot is the first flying biohybrid system to successfully perform odor localization in a confined space, and it is able to do so while detecting and avoiding obstacles in its flight path. We show that insect antennae respond more quickly than metal oxide gas sensors, enabling odor localization at an improved speed over previous flying robots. By using the insect antennae, we anticipate a feasible path toward improved chemical specificity and sensitivity by leveraging recent advances in gene editing.”
How Does it Work?
In nature, a moth uses its antennae to sense chemicals in its environment and navigate toward sources of food or a potential mate.
“Cells in a moth antenna amplify chemical signals,” said study co-author Thomas Daniel, PhD, UW Professor of Biology, in UW News. “The moths do it really efficiently—one scent molecule can trigger lots of cellular responses, and that’s the trick. This process is super-efficient, specific, and fast.”
Because the moth antenna is hollow, researchers are able to add wires into the ends of the antenna. By connecting the antenna to an electrical circuit, they can measure the average signal from all of the cells in the antenna. When compared to a metal oxide gas sensor, the antenna-powered sensor responded more quickly to a floral scent. It also took less time to recover between tracking puffs of scent.
Anderson compared the antenna-drone circuitry to a human heart monitor.
“A lot like a heart monitor, which measures the electrical voltage that is produced by the heart when it beats, we measure the electrical signal produced by the antenna when it smells odor,” Anderson told WIRED. “And very similarly, the antenna will produce these spike-shaped pulses in response to patches of odor.”
Making a Drone Hunt Like a Moth
Anderson told WIRED her team programmed the drone to hunt for odors using the same technique moths employ to stay targeted on an odor, called crosswind casting.
“If the wind shifts, or you fly a little bit off-course, then you’ll lose the odor,” Anderson said. “And so, you cast crosswind to try and pick back up that trail. And in that way, the Smellicopter gets closer and closer to the odor source.”
However, the researchers had to figure out how to keep the commercially available $195 Crazyflie drone facing upwind. The fix, co-author and co-advisor Sawyer Fuller, PhD, UW Assistant Professor of Mechanical Engineering told UW News, was to add two plastic fins to create drag and keep the vehicle on course.
“From a robotics perspective, this is genius,” Fuller said. “The classic approach in robotics is to add more sensors, and maybe build a fancy algorithm or use machine learning to estimate wind direction. It turns out, all you need is to add a fin.”
Other Applications for Odor Detecting Robots
While any practical clinical application of this breakthrough is years away, the scientific team’s next step is to use gene editing to engineer moths with antennae sensitive to a specific desired chemical, such as those found in explosives.
“I think it is a powerful concept,” roboticist Antonio Loquercio, a PhD candidate in machine learning at the University of Zurich who researches drone navigation, told WIRED. “Nature provides us plenty of examples of living organisms whose life depends on this capacity. This could have as well a strong impact on autonomous machines—not only drones—that could use odors to find, for example, survivors in the aftermath of an earthquake or could identify gas leaks in a man-made environment.”
Could a palm-sized autonomous device one day be used to not only track down explosives and gas leaks but also to detect disease?
As clinical pathologists and medical laboratory scientists know, dogs have demonstrated keen ability to detect disease using their heightened sense of smell.
Therefore, it is not inconceivable that smell-seeking technology might one day be part of clinical laboratory testing for certain diseases.
This latest research is another example of how breakthroughs in unrelated fields of science offer the potential for creation of diagnostic tools that one day may be useful to medical laboratories.
The researchers also found that certain molecules, when added to cancer drugs, can prevent chromosome shattering from occurring in a discovery that may be useful to pathologists and oncologists
Anatomic pathologists who diagnose tissue and closely monitor advances in cancer diagnostics and therapy will be interested in a recent study into how a mutational process known as chromothripsis (chromosome shattering) can promote cancer cell growth in humans and increase resistance to cancer drug therapies.
The study, which was published in the journal Nature, titled, “Chromothripsis Drives the Evolution of Gene Amplification in Cancer,” provides insights into how cancer cells can adapt to different environments and also may suggest potential solutions to drug resistance among cancer patients.
Led by researchers from the University of California San Diego School of Medicine and the UC San Diego branch of the Ludwig Institute for Cancer Research, the discovery could open up a new field in cancer diagnostic testing, where the pathology laboratory analyzes a cancer patient’s tumor cells to determine where chromosomal damage exists. This knowledge could then inform efforts to repair damaged chromosomes or to identify which therapeutic drugs would be most effective in treating the patient, a key element of precision medicine.
Shattered Chromosomes
Chromosomes that undergo chromothripsis shatter or fragment into several pieces and then are stitched back together by a DNA repair processes. However, not all of the fragments make it back into the repaired chromosome, and this can be a problem.
“During chromothripsis, a chromosome in a cell is shattered into many pieces, hundreds in some cases, followed by reassembly in a shuffled order,” Shoshani told Genetic Engineering and Biotechnology News (GEN News). “Some pieces get lost while others persist as extra-chromosomal DNA (ecDNA). Some of these ecDNA elements promote cancer cell growth and form minute-sized chromosomes called double minutes.”
Studies have shown that up to half of all cancer cells contain cancer-promoting ecDNA chromosome fragments.
Some Cancer Drugs Could be Fueling Drug Resistance
To perform their study, the UC San Diego/Ludwig scientists sequenced entire genomes of cancer cells that had developed drug resistance. Their research revealed that chromothripsis prompts and drives the formation of ecDNA and that the process can also be induced by some chemotherapeutic drugs. The researchers also discovered that the particular type of damage these drugs may cause can provide an opening for ecDNA to reintegrate back into chromosomes.
“We show that when we break a chromosome, these ecDNAs have a tendency to jump into the break and seal them, serving almost like a DNA glue,” Shoshani said in the news release. “Thus, some of the very drugs used to treat cancers might also be driving drug resistance by generating double-stranded DNA breaks.”
Preventing DNA Shattering and Reducing Drug Resistance
The scientists also discovered that ecDNA formation could be halted by pairing certain cancer drugs with molecules that prevent DNA shattering from occurring in the first place, thus reducing drug resistance.
“This means that an approach in which we combine DNA repair inhibitors with drugs such as methotrexate or vemurafenib could potentially prevent the initiation of drug resistance in cancer patients and improve clinical outcomes,” Shoshani said.
“Our identifications of repetitive DNA shattering as a driver of anticancer drug resistance and of DNA repair pathways necessary for reassembling the shattered chromosomal pieces has enabled rational design of combination drug therapies to prevent development of drug resistance in cancer patients, thereby improving their outcome,” Don Cleveland, PhD, Head of the Cleveland Laboratory of Cell Biology at the Ludwig Institute for Cancer Research and one of the authors of the paper, told GEN News.
This research from the University of California San Diego School of Medicine and the UC San Diego branch of the Ludwig Institute for Cancer Research is the latest example of how scientists have gained useful insights into how human genomes operate. More research and clinical studies are needed to solidify the advantages of this study, but the preliminary results are promising and could lead to new cancer diagnostics and therapies.
Researchers find declining antibody levels in SARS-CoV-2 patients are offset by T cells and B cells that remain behind to fight off reinfection
Questions remain regarding how long antibodies produced by a COVID-19 vaccine or natural infection will provide ongoing protection against SARS-CoV-2. However, a new study showing COVID-19 immunity may be “robust” and “long lasting” may signal important news for clinical laboratories and in vitro diagnostics companies developing serological tests for the coronavirus disease.
The LJI research team analyzed blood samples from 188 COVID-19 patients, 7% of whom had been hospitalized. They measured not only virus-specific antibodies in the blood stream, but also memory B cell infections, T helper cells, and cytotoxic (killer) T cells.
While antibodies eventually disappear from the blood stream, T cells and B cells appear to remain to fight future reinfection.
“As far as we know, this is the largest study ever for any acute infection that has measured all four of those components of immune memory,” Crotty said in a La Jolla Institute news release.
The LJI researchers found that virus-specific antibodies remained in the blood stream months after infection while spike-specific memory B cells—which could trigger an accelerated and robust antibody-mediated immune response in the event of reinfection—actually increased in the body after six months. In addition, COVID-19 survivors had an army of T cells ready to halt reinfection.
“Our data show immune memory in at least three immunological compartments was measurable in ~95% of subjects five to eight months post symptom onset, indicating that durable immunity against secondary COVID-19 disease is a possibility in most individuals,” the study concludes. The small percentage of the population found not to have long-lasting immunity following COVID-19 infection could be vaccinated in an effort to stop reinfection from occurring on the way to achieving herd immunity, the LJI researchers maintained.
Do COVID-19 Vaccines Create Equal Immunity Against Reinfection?
Whether COVID-19 vaccinations will provide the same immune response as an active infection has yet to be determined, but indications are protection may be equally strong.
“It is possible that immune memory will be similarly long lasting similar following vaccination, but we will have to wait until the data come in to be able to tell for sure,”
LJI Research Professor Daniela Weiskopf, PhD, said in the LJI statement. “Several months ago, our studies showed that natural infection induced a strong response, and this study now shows that the response lasts. The vaccine studies are at the initial stages, and so far, have been associated with strong protection. We are hopeful that a similar pattern of responses lasting over time will also emerge for the vaccine-induced responses.”
The study’s authors cautioned that people previously diagnosed with COVID-19 should not assume they have protective immunity from reinfection, the Washington Post noted. In fact, according to the LJI news release, researchers saw a “100-fold range in the magnitude of immune memory.”
Previous Studies Found Little Natural Immunity Against SARS-CoV-2 Reinfection
The Scientist reported that several widely publicized previous studies raised concerns that immunity from natural infection was fleeting, perhaps dwindling in weeks or months. And a United Kingdom study published in Nature Microbiology found that COVID-19 generated “only a transient neutralizing antibody response that rapidly wanes” in patients who exhibited milder infection.
Daniel M. Davis, PhD, Professor of Immunology at the University of Manchester, says more research is needed before scientists can know for certain how long COVID-19 immunity lasts after natural infection.
“Overall, these results are interesting and provocative, but more research is needed, following large numbers of people over time. Only then, will we clearly know how many people produce antibodies when infected with coronavirus, and for how long,” Davis told Newsweek.
While additional peer-reviewed studies on the body’s immune response to COVID-19 will be needed, this latest study from the La Jolla Institute for Immunity may help guide clinical laboratories and in vitro diagnostic companies that are developing serological antibody tests for COVID-19 and lead to more definitive answers as to how long antibodies confer protective immunity.