Small handheld device uses sound waves to detect certain clinical laboratory biomarkers in blood samples
University of Colorado Boulder researchers have developed a novel technology that uses sound waves to test for biomarkers in blood samples. In addition to being very easy to use, the handheld device is portable, highly sensitive, and delivers results in minutes. Though not ready for clinical use, this is yet another example of how researchers are developing faster diagnostic tests that can be performed in near-patient settings, and which do not have to be done in core laboratories, shortening time to answer.
The small instrument—referred to as an “acoustic pipette”—delivers sound waves to tiny particles within the device called “functional negative acoustic contrast particles” (fNACPs). These particles are cell-sized balls that can be customized with different coatings to identify specific biomarkers—such as viruses or proteins—in tiny blood samples, according to a news release.
To operate the device, the custom fNACPs are mixed with a drop of blood and then placed inside the acoustic pipette. The mixture is then blasted with sound waves, which forces particles carrying certain biomarkers to one side of the chamber where they are trapped while the rest of the blood is expelled. The captured biomarkers are then labeled with fluorescent tags and examined with lasers to determine how much of a specific biomarker is present.
“We’re basically using sound waves to manipulate particles to rapidly isolate them from a really small volume of fluid,” said Cooper Thome (above), PhD candidate in Chemical and Biological Engineering at UC Boulder and first author of the study in a news release. “It’s a whole new way of measuring blood biomarkers,” he added. Should further studies validate this approach, clinical laboratories may be able to use this technology to perform diagnostic tests with smaller volumes of patient samples. (Photo copyright: University of Colorado Boulder.)
Blood Testing Quickly and in Multiple Settings
To test their invention, the UC Boulder researchers examined antibodies against a protein called ovalbumin, which is found in egg whites and often used in the development of various vaccines. The scientists discovered that their device could detect the antibodies even in low amounts.
Current rapid tests known as lateral-flow assays can detect specific biomarkers in blood or urine samples but cannot determine how much of the biomarker is present. Enzyme-linked immunotherapy assays (ELISA), the leading clinical laboratory blood test, requires expensive equipment and can take hours to days for results to be received.
With UC Boulder’s new handheld device, tiny blood samples collected from a single finger prick could ensure accurate test results are available quickly at the point of care as well as outside of traditional healthcare settings. This would greatly benefit people in developing nations and underserved communities and may help ease test anxiety for individuals who are apprehensive about traditional blood tests.
“We’ve developed a technology that is very user friendly, can be deployed in various settings, and provides valuable diagnostic information in a short time frame,” said Wyatt Shields IV, PhD, Assistant Professor, Department of Chemical and Biological Engineering, UC Boulder, and senior author of the research in the news release.
“In our paper, we demonstrate that this pipette and particle system can offer the same sensitivity and specificity as a gold-standard clinical test can but within an instrument which radically simplifies workflows,” he added. “It gives us the potential to perform blood diagnostics right at the patient’s bedside.”
The graphic above, taken from UC Boulder’s published paper, illustrates how “fNACPs capture target biomarkers from whole blood samples. fNACPs are purified from blood components by acoustic trapping and captured biomarkers are labeled with a fluorescent antibody within the acoustic pipette. fNACP fluorescence is then measured to determine biomarker presence and concentration.” (Graphic/caption copyright: University of Colorado Boulder.)
Not Like Theranos
The authors of the UC Boulder study are cognizant of some skepticism surrounding the field of biosensing, especially after the downfall of Theranos. The scientists insist their technology is different and based on systematic experiments and peer-reviewed research.
“While what they (Theranos) claimed to do isn’t possible right now, a lot of researchers are hoping something similar will be possible one day,” said Thome in the news release. “This work could be a step toward that goal—but one that is backed by science that anybody can access.”
The device is still in its initial proof-of-concept stage, but the UC Boulder scientists have applied for patents for the apparatus and are searching for ways to scale its use and expand its capabilities.
“We think this has a lot of potential to address some of the longstanding challenges that have come from having to take a blood sample from a patient, haul it off to a lab, and wait to get results back,” Shields noted.
More research, studies, and regulatory reviews will be needed before this technology becomes available for regular, widespread use. But UC Boulder’s new blood testing device is another example of a research team using novel technology to test for known biomarkers in ways that could improve standard clinical laboratory testing.
PRESS RELEASE FOR IMMEDIATE RELEASE THE DARK REPORT21806 Briarcliff Dr.Spicewood, TX 78669512-264-7103 o512-264-0969 f Media Contact: Bill Sinagrainfo@darkreport.com Free Webinar: Pharmacogenomics: Leveraging Capacity to Expand Your Molecular Laboratory Capabilities AUSTIN, TEXAS (September 29, 2022) – A new, free Dark Daily webinar will help laboratories discover how to expand into pharmacogenomics (PGx) and learn about the importance of genetics and laboratory services in medication...
Free Webinar: Pharmacogenomics: Data and Innovation to Deliver Precise and Appropriate Medication Use PRESS RELEASE FOR IMMEDIATE RELEASE THE DARK REPORT21806 Briarcliff Dr.Spicewood, TX 78669512-264-7103 o512-264-0969 f Media Contact: Bill Sinagrainfo@darkreport.com AUSTIN, TEXAS (November 9, 2021) – A new, free webinar by Dark Daily and sponsored by Thermo Fisher Scientific explores how pharmacogenomics can help reduce adverse responses, deliver treatments faster and lower medical costs. On...
Though more payers are covering laboratory-developed genetic tests for conditions such as depression, the tests remain uncleared by the FDA
Clinical pathologists interested in pharmacogenetics tests for depression and other psychiatric disorders may be interested to learn that UnitedHealthcare (NYSE:UNH) announced in its Network Bulletin a change to its Molecular Pathology Policy and is now covering certain molecular diagnostics. That’s despite the federal Food and Drug Administration (FDA) warning “against the use of many genetic tests with unapproved claims to predict patient response to specific medications.”
In its Safety Communication, the FDA stated healthcare providers and clinical laboratories that “are using, or considering using, a genetic test to predict a patient’s response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication’s effects has not been established.”
In its coverage of the FDA’s warning, The Dark Report, sister publication to Dark Daily, wrote, “Serious concerns are associated with some pharmacogenetic tests and whether physicians have the training and knowledge needed to use this genetic test data appropriately in patient care.”
Should the FDA Even Be Regulating Clinical Laboratory Tests?
Experts note that it is notoriously difficult in some cases for providers to identify which drug or group of drugs is most likely to help a patient with a psychiatric disorder such as depression. Pharmaceuticals that work well for one individual may actually worsen things for someone else.
Nevertheless, the idea that a genetic test could reveal how a psychiatric patient is likely to react to a particular drug is extremely appealing. It could save years of trial and error, which is often terribly disruptive for the patient.
Currently, there’s quite a debate about whether these tests should be available, who should take them, and whether they offer any kind of guidance for providers. There’s even a faction that maintains the FDA should not be regulating clinical laboratory tests at all.
In its coverage of the FDA’s warning, NPR reported that Victoria Pratt, PhD (above), a medical and clinical molecular geneticist who at the time was President of the Association for Molecular Pathology (AMP), said, “Tests conducted in a lab are a medical service, not a medical device that’s shipped like a product. As a medical service, clinical laboratories are already regulated by the Centers for Medicare and Medicaid Services. It would be redundant to have dual regulation by both the FDA and CMS.” (Photo copyright: AMP.)
Does Evidence of Pharmacogenomics Effectiveness Exist?
Studies regarding the effectiveness of genetic tests for psychiatric disorders have had, at best, mixed results. “Genes determine some of our risk for depression and some of our response to treatment,” wrote Bruce Cohen, MD, PhD, and George Zubenko, MD, PhD, in a Harvard Health Blog post, titled, “Gene Testing to Guide Antidepressant Treatment: Has Its Time Arrived?” The authors go on to say that although the genes that are tested in the panels can have an effect on the levels of the drugs in the patient’s blood, they “generally don’t predict clinical response.”
The authors then discussed the results of a dozen studies that looked into the genetic panels. “Most studies were completely unblinded,” they wrote. “Even with that bias, the use of gene results showed no evidence of effectiveness.”
Advocacy Groups, Payors, and Clinicians Support Pharmacogenomics
Nevertheless, even with the FDA’s warning—and tepid study results— pharmacogenetic testing has its supporters. In large part, that is because identifying the most appropriate medication for any given patient can be incredibly difficult.
“Right now, one of our greatest frustrations is that when [patients] comes in with depression, we have very little idea of what the right treatment for them is,” said Amit Etkin, MD, PhD, Founder and CEO of Alto Neuroscience. Etkin is a professor in the Department of Psychiatry and Behavioral Sciences at Stanford and a member of the Wu Tsai Neuroscience Institute. He authored a study published in Nature that investigated measuring patients’ brainwaves to identify the most appropriate treatment. “Essentially, the medications are chosen by trial and error.”
“You use the science that you currently have,” Reyna Taylor, Vice President of Public Policy and Advocacy, National Council for Behavioral Health, told NPR. She says that doctors should be able to use the tests to inform their choice of medication.
Daniel Mueller, MD, PhD, a psychiatrist and clinical scientist, agrees. Mueller is a professor at the University of Toronto and head of the Pharmacogenetic Research Clinic at the Center for Addiction and Mental Health (CAMH) in Toronto. He told NPR that the pharmacogenomic clinical laboratory tests “are not an alternative intervention. It’s additional information.” He suggests that anyone who can afford the test should take it, because it could help them avoid “the cost of depression and weeks of suffering.”
The decision by UnitedHealthcare to cover genetic tests for depression and other psychiatric disorders could be important. “We expect this to be a tipping point,” Shawn Patrick O’Brien, CEO of Genomind, told NPR, adding that he expects other insurance companies to begin covering the cost of the tests, as well, “because they don’t want to be uncompetitive in the marketplace.”
Historically, there have been few clinical laboratory tests for patients with psychiatric disorders, and while these tests may open a new market in the future, for now, caution is warranted. In addition to the warning from the FDA, there will likely be challenges regarding physician education and curbing fraud.
