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

Direct-to-Consumer Health Testing Company LetsGetChecked Acquires Veritas Genetics, Veritas Intercontinental, and BioIQ

As demand for DTC at-home genetic testing increases among consumers and healthcare professionals, clinical laboratories that offer similar assays may want to offer their own DTC testing program

Things are happening in the direct-to-consumer (DTC) medical laboratory testing market. Prior to the pandemic, the number of consumers interested in ordering their own diagnostic tests grew at a rapid rate. The SARS-CoV-2 outbreak, however, and the need for consumers to access COVID-19 tests, caused DTC test sales to skyrocket.

One company benefiting from the DTC trend is New York City-based LetsGetChecked. In March, it announced its acquisition of Veritas Genetics which included that company’s Veritas Intercontinental business division. No purchase price was disclosed.

LetsGetChecked describes itself as a “virtual care company that allows customers to manage their health from home, providing direct access to telehealth services, pharmacy, and [clinical] laboratory tests with at-home sample collection kits for a wide range of health conditions,” according to the company’s LinkedIn page.

The acquisition of Veritas brings whole genome sequencing capabilities to LetsGetChecked, according to MobiHealthNews.

“Through these acquisitions, LetsGetChecked will leverage the power of whole genome sequencing to launch a full lifecycle of personalized healthcare, delivering the most comprehensive health testing and care solution on the market,” said Peter Foley, Founder and CEO of LetsGetChecked in a press release.

“By integrating Veritas Genetics’ and Veritas Intercontinental’s capabilities with LetsGetChecked’s scalable diagnostic and virtual care infrastructure, we are able to turn comprehensive genetic insights into practical recommendations and lifestyle changes, guided by clinical experts,” he added.

George Church, PhD
“Our mission to deliver the benefits of whole genome sequencing to millions of individuals continues as part of the LetsGetChecked family. I am particularly excited about the opportunity to combine genetic testing with the broad spectrum of virtual and at-home care models offered by LetsGetChecked. I expect these acquisitions will change the future of personalized healthcare as we know it,” said geneticist George Church, PhD, co-founder of Veritas Genetics, and Professor of Health Sciences and Technology at Harvard and MIT, in a press release. (Photo copyright: Wyss Institute at Harvard University.)

Leveraging the Power of Whole Genome Sequencing

To date, LetsGetChecked claims it has delivered nearly three million at-home direct-to-consumer tests and served more than 300 corporate customers with testing services and biometric screening solutions since its founding in 2015.

The company focuses on manufacturing, logistics, and lab analysis in its CAP-accredited, CLIA-certified laboratory in Monrovia, Calif., as well as physician support, and prescription fulfillment. The DTC company’s products include at-home tests for women’s health, men’s health, basic wellness, sexual health, and SARS-CoV-2 testing.

Veritas Genetics also was a DTC testing company co-founded by internationally-known geneticist George Church, PhD. In 2016, the company announced it would deliver a whole human genome sequence (WGS) for just $999—breaking the $1,000 cost barrier for whole genome sequencing.

In “Veritas Genetics Drops Its Price for Clinical-Grade Whole-Genome Sequencing to $599, as Gene Sequencing Costs Continue to Fall,” Dark Daily covered how just three years later, in 2019, the company announced it would do a WGS for only $599.

“There is no more comprehensive genetic test than your whole genome,” Rodrigo Martinez, former Veritas Chief Marketing and Design Officer, told CNBC. “So, this is a clear signal that the whole genome is basically going to replace all other genetic tests. And this [price drop] gets it closer and closer and closer.”

That market strategy did not succeed. By the end of 2019, the company announced it would cease operations in the United States but continue operations in Europe and Latin America. It has sought a buyer for the company since that time. Now, almost three years later, LetsGetChecked will become the new owner of Veritas Genetics.

Veritas’ primary product, myGenome was launched in 2018 as a whole genome sequencing and interpretation service to help consumers improve their health and increase longevity. The myGenome test screens for and provides insight on many hereditary diseases such as cancer, cardiovascular disease, and neurological disorders. It also provides observations on more than 50 personal traits and ancestry information.

In addition to bringing whole genome sequencing abilities to its test offerings for consumers, LetsGetChecked hopes the acquisitions will create new testing capabilities such as pharmacogenomics, cancer and viral screenings, and maternal fetal screenings.

“By integrating Veritas Genetics’ and Veritas Intercontinental’s genetics offering with our scalable virtual care infrastructure, we are able to leverage the power of whole genome sequencing to launch a full lifecycle of personalized healthcare, which has always been our goal,” Foley told MobiHealthNews.

Veritas Genetics and Veritas Intercontinental will continue to operate under the LetsGetChecked family of companies.

BioIQ also Acquired by LetsGetChecked

In early May, LetsGetChecked also acquired diagnostic testing and health improvement technology company BioIQ, which will continue to operate as a wholly-owned subsidiary.

BioIQ offers at-home tests, health screenings, and vaccinations to consumers. The company’s products include:

  • Heart health panel,
  • Lipid panel,
  • Respiratory panel,
  • Prevention panel, and
  • Wellness panel.

Individual tests offered by BioIQ include:

  • A1C,
  • COVID-19,
  • Hepatitis C test and
  • Sexually transmitted diseases.

BioIQ also offer e-vouchers for health screenings and vaccinations at participating retail pharmacies, clinical laboratories, and physician’s offices.

“The future of healthcare is in providing high-quality at-home diagnostics and care that comprehensively serve an individual’s health needs throughout their whole life,” said Foley in a press release about the BioIQ acquisition. “With this acquisition, LetsGetChecked gains a trusted partner with an extensive knowledge base and a breadth of experience in serving health plans and employer markets to deliver healthcare solutions at scale.”

These acquisitions by LetsGetChecked demonstrate how genetic testing companies are pivoting to new strategies. Clinical laboratories that perform genetic testing will want to monitor how these partnerships unfold in the future as healthcare consumers and providers continue to embrace at-home genetic testing.

JP Schlingman

Related Information:

Genetic Sequencing Opens New Doors—and Concerns—for Home Health Testing

LetsGetChecked to Acquire Veritas Genetics and Veritas Intercontinental to Unlock the Future of Personalized At-Home Healthcare

LetsGetChecked Scoops Up Genomics Company Veritas Genetics

Veritas Genetics Drops Its Price for Clinical-Grade Whole-Genome Sequencing to $599, as Gene Sequencing Costs Continue to Fall

LetsGetChecked Completes Acquisition of BioIQ

Columbia University Researchers Say New High-Speed 3D Microscope Could Replace Traditional Biopsy, with Implications for Surgical Pathology

Columbia University’s MediSCAPE enables surgeons to examine tissue structures in vivo and a large-scale clinical trial is planned for later this year

Scientists at Columbia University in New York City have developed a high-speed 3D microscope for diagnosis of cancers and other diseases that they say could eventually replace traditional biopsy and histology “with real-time imaging within the living body.”

The technology is designed to enable in situ tissue analysis. Known as MediSCAPE, the microscope is “capable of capturing images of tissue structures that could guide surgeons to navigate tumors and their boundaries without needing to remove tissues and wait for pathology results,” according to a Columbia University news story.

The research team, led by Columbia University professor of biomedical engineering and radiology Elizabeth Hillman, PhD, described the technology in a paper published in Nature Biomedical Engineering, titled, “High-Speed Light-Sheet Microscopy for the In-Situ Acquisition of Volumetric Histological Images of Living Tissue.”

“The way that biopsy samples are processed hasn’t changed in 100 years, they are cut out, fixed, embedded, sliced, stained with dyes, positioned on a glass slide, and viewed by a pathologist using a simple microscope. This is why it can take days to hear news back about your diagnosis after a biopsy,” said Hillman in the Columbia news story.

“Our 3D microscope overcomes many of the limitations of prior approaches to enable visualization of cellular structures in tissues in the living body. It could give a doctor real-time feedback about what type of tissue they are looking at without the long wait,” she added in I News.

Hillman’s team previously used the technology—originally dubbed SCAPE for “Swept Confocally Aligned Planar Excitation” microscopy—to capture 3D images of neurological activity in living samples of worms, fish, and flies. In their recent study, the researchers tested the technology with human kidney tissue, a human volunteer’s tongue, and a mouse with pancreatic cancer.

Shana M. Coley, MD, PhD
“This was something I didn’t expect—that I could actually look at structures in 3D from different angles,” said nephropathologist and study co-author Shana M. Coley, MD, PhD (above), Director, Transplant Translational Research and Multiplex Imaging Center at Arkana Laboratories, in the Columbia news story. At the time of the Columbia study, Coley was an assistant professor at Columbia University and a renal pathologist at the Columbia University Medical Center. “We found many examples where we would not have been able to identify a structure from a 2D section on a histology slide, but in 3D we could clearly see its shape. In renal pathology in particular, where we routinely work with very limited amounts of tissue, the more information we can derive from the sample, the better for delivering more effective patient care,” she added. (Photo copyright: Arkana Laboratories.)

How MediSCAPE Works

Unlike traditional 3D microscopes that use a laser to scan tiny spots of a tissue sample and then assemble those points into a 3D image, the MediSCAPE 3D microscope “illuminates the tissue with a sheet of light—a plane formed by a laser beam that is focused in a special way,” I News reported.

The MediSCAPE microscope thus captures 2D slices which are rapidly stacked into 3D images at a rate of more than 10 volumes per second, according to I News.

“One of the first tissues we looked at was fresh mouse kidney, and we were stunned to see gorgeous structures that looked a lot like what you get with standard histology,” said optical systems engineer and the study’s lead author, Kripa Patel, PhD, in the Columbia news story. “Most importantly, we didn’t add any dyes to the mouse—everything we saw was natural fluorescence in the tissue that is usually too weak to see.

“Our microscope is so efficient that we could see these weak signals well,” she continued, “even though we were also imaging whole 3D volumes at speeds fast enough to rove around in real time, scanning different areas of the tissue as if we were holding a flashlight.”

A big advantage of the technology, Hillman noted, is the ability to scan living tissue in the body.

“Understanding whether tissues are staying healthy and getting good blood supply during surgical procedures is really important,” she said in the Columbia news story. “We also realized that if we don’t have to remove (and kill) tissues to look at them, we can find many more uses for MediSCAPE, even to answer simple questions such as ‘what tissue is this?’ or to navigate around precious nerves. Both of these applications are really important for robotic and laparoscopic surgeries, where surgeons are more limited in their ability to identify and interact with tissues directly.”

Clinical Trials and FDA Clearance

Early versions of the SCAPE microscopes were too large for practical use by surgeons, so Columbia post-doctoral research scientist Wenxuan Liang, PhD, co-author of the study, helped the team develop a smaller version that would fit into an operating room.

Later this year, the researchers plan to launch a large-scale clinical trial, I News reported. The Columbia scientists hope to get clearance from the US Food and Drug Administration (FDA) to develop a commercialized version of the microscope.

“They will initially seek permission to use it for tumor screening and guidance during operations—a lower and easier class of approval—but ultimately, they hope to be allowed to use it for diagnosis,” Liang wrote.

Charles Evans, PhD, research information manager at Cancer Research UK, told I News, “Using surgical biopsies to confirm a cancer diagnosis can be time-consuming and distressing for patients. And ensuring all the cancerous tissue is removed during surgery can be very challenging unaided.”

He added, “more work will be needed to apply this technique in a device that’s practical for clinicians and to demonstrate whether it can bring benefits for people with cancer, but we look forward to seeing the next steps.” 

Will the Light Microscope be Replaced?

In recent years, research teams at various institutions have been developing technologies designed to enhance or even replace the traditional light microscope used daily by anatomic pathologists across the globe.

And digital scanning algorithms for creating whole-slide images (WSIs) that can be analyzed by pathologists on computer screens are gaining in popularity as well.

Such developments may spark a revolution in surgical pathology and could signal the beginning of the end of the light microscope era.

Surgical pathologists should expect to see a steady flow of technologically advanced systems for tissue analysis to be submitted to the FDA for pre-market review and clearance for use in clinical settings. The light microscope may not disappear overnight, but there are a growing number of companies actively developing different technologies they believe can diagnose either or both tissue and digital images of pathology slides with accuracy comparable to a pathologist.

Stephen Beale

Related Information:

New Technology Could Make Biopsies a Thing of the Past

Cancer Care: 3D Microscope That Could Replace Tumor Biopsies Is ‘As Revolutionary as Ultrasound’

High-Speed Light-Sheet Microscopy for the In-Situ Acquisition of Volumetric Histological Images of Living Tissue

SCAPE Microscopy

UC Davis Researchers Develop Microscope That Uses Ultraviolet Light for Diagnosis, Eliminates Need for Traditional Histology Slide Preparation

Attention All Surgical Pathologists: Algorithms for Automated Primary Diagnosis of Digital Pathology Images Likely to Gain Regulatory Clearance in Near Future

Researchers Develop ‘Smart’ Microneedle Adhesive Bandage System for Monitoring Sodium, Glucose, pH, and More

Platform could be next breakthrough in quest for painless technology to replace in-patient phlebotomy blood draws for many clinical laboratory tests

In a proof-of-concept study, scientists from Israel and China have developed a “smart” microneedle adhesive bandage that measures and monitors in real time three critical biomarkers that currently require invasive blood draws for medical laboratory tests commonly performed on patients in hospitals.

The “smart” microneedle system developed by Israeli scientists from Technion-Israel Institute of Technology working with their Chinese counterparts from the Eighth Affiliated Hospital Sun Yat-Sen University in Shenzhen, Lanzhou University, and Xidian University in Xi’an, continuously monitors patients’ sodium, glucose, and pH levels.

According to a Technion news release, the microneedles are short, thin, and relatively painless because they only extend through the outer layer of skin to reach the interstitial fluid underneath. The needle system attaches to the patient’s skin using an adhesive patch and transfers data wirelessly to both doctor and patient in real time through cloud and Internet of Things (IoT) technologies.

Such a novel technology that allows inpatients to be monitored for key biomarkers without the need for a phlebotomist to collect blood for testing will be attractive and would likely improve the patient’s experience.

It also could reduce the volume of specimen required, potentially eliminating the invasive specimen collection procedure altogether.

The researchers published their findings in the journal Advanced Materials, titled, “A Wearable Microneedle-Based Extended Gate Transistor for Real-Time Detection of Sodium in Interstitial Fluids.”

Hossam Haick, PhD
“To adapt the technology to daily life, we have developed a unique [adhesive bandage] made of a flexible and soft polymer that stretches and contracts along with the skin and therefore does not interfere with any action whatsoever,” said Hossam Haick, PhD (above), in a Technion news release. “Since it is important for us that the system is available to everyone, we made sure to use relatively inexpensive materials, so the final product will not be expensive. The technology we have developed represents a leap forward in diagnosing diseases and continuous physiological monitoring at home and in the clinic.” Such a real-time monitoring device could eliminate clinical laboratory testing for certain biomarkers that currently require invasive blood draws. (Photo copyright: Technion-Israel Institute of Technology.)

Leap Forward in Diagnostic Testing and Disease Monitoring

As pathologists and medical laboratory scientists are aware, sodium is a prominent prognostic biomarker for assessing certain blood conditions such as dysnatremia, the presence of too much or too little sodium. It’s an essential element found in blood cells and blood fluid that plays a vital role in transmitting signals to the nervous system, as well as in other biological functions.

Currently, a patient’s sodium levels are monitored using a sodium blood test, which may be included in both a basic metabolic panel and a comprehensive metabolic panel.

Led by Hossam Haick, PhD, head of the LNDB (Laboratory for Nanomaterials-based Devices) group and Dean of Certification Studies at Technion, the team of scientists tested their device’s effectiveness at monitoring patients’ blood for both hypernatremia (high concentration of sodium in the blood) as well as hyponatremia (low concentration of sodium in the blood).

Both conditions can affect neurological function and lead to loss of consciousness and coma. Thus, early monitoring is critical.

“As of now, detection and monitoring of sodium levels in the human body is carried out by means of laborious and bulky laboratory equipment, or by offline analysis of various bodily fluids,” the study’s authors explained in the news release. Use of the smart microneedle patch, they added, allows the patient to continue about their day as normal, as well as gives their doctor time to attend to more patients.

The “innovative stretchable, skin-conformal and fast-response microneedle extended-gate FET (field-effect transistor) biosensor [integrated with] a wireless-data transmitter and the Internet-of-Things cloud for real-time monitoring and long-term analysis [could] eventually help [bring] unlimited possibilities for efficient medical care and accurate clinical decision-making,” noted the study’s authors in Advanced Materials.

More research will be needed to determine whether this latest medical technology breakthrough will lead to a viable minimally invasive method for measuring, diagnosing, and monitoring medical conditions, but Technion’s platform appears to be another step toward a long-sought alternative to painful blood draws.

Further, pathologists and clinical laboratory managers should expect more products to hit the market that are designed to collect a lab specimen without the need for a trained phlebotomist. Companies developing these products recognize that recruiting and retaining trained phlebotomist is an ongoing concern for medical labs. Thus, to have a method of collecting a lab specimen that is simple and can be done by anyone—including patients themselves—would be an important benefit.

Andrea Downing Peck

Related Information:

A Wearable Microneedle-Based Extended Gate Transistor for Real-Time Detection of Sodium in Interstitial Fluids

Researchers at the Technion Developed a Flexible Microneedles Platform That Provides Quick, Continuous, and Pain-Free Diagnosis

Microneedle Drug Delivery Systems Market Are Slated to Increase at Healthy 6.6% CAGR Over the Forecast Period

King’s College London Researchers Discover Causal Link between Blood Type and COVID-19 Severity; May Provide Clinical Laboratories with a Useful Diagnostic Insight

Findings are ‘a vital first step in discovering potentially valuable targets for development of new [COVID-19] treatments,’ noted co-first author of the study

Researchers at King’s College London (KCL) have determined that levels of certain blood proteins specific to each person’s blood type can be “causally linked” to an increased risk of hospitalization and death from a COVID-19 infection. The scientists also found that a person’s genetics play a key role in establishing the levels of those proteins in the blood.

This is relevant for clinical laboratories—particularly hospital/health system laboratories—because testing for specific proteins in the blood by medical laboratories could help flag incoming patients at higher risk for an acute COVID-19 infection.

Also, “By identifying this suite of proteins, the research has highlighted a number [of] possible targets for drugs that could be used to help treat severe COVID-19,” noted a KCL news release.

Identifying certain drugs that would be more effective for specific individuals or healthcare groups is a core goal of precision medicine.

The KCL researchers published their findings in the journal PLOS Genetics, titled, “Proteome-wide Mendelian Randomization Identifies Causal Links between Blood Proteins and Severe COVID-19.”

Alish Palmos, PhD
“We have used a purely genetic approach to investigate a large number of blood proteins and established that a handful have causal links to the development of severe COVID-19,” said Alish Palmos, PhD (above), Postdoctoral Research Associate, King’s College London Social, Genetic and Developmental Psychiatry Center, and co-first author of the study. “Honing in on this group of proteins is a vital first step in discovering potentially valuable targets for development of new treatments.” Medical laboratories may soon be able to use this knowledge as a way to determine risk for severe COVID-19 hospitalization, as well as to guide decisions on how to use new precision medicine drugs for combating the infection. (Photo copyright: Twitter.)

Genetic Variants Linked to Causality

Since the COVID-19 pandemic began in late 2019, scientists and researchers have been vigorously trying to understand the SARS-CoV-2 coronavirus and determine why some patients have more severe symptoms than others.

To conduct their study, the KCL researchers screened more than 3,000 blood proteins to identify which proteins have a causal link to hospitalization risk, the need for respiratory support, and death from a severe COVID-19 infection.

“Causality between exposure and disease can be established because genetic variants inherited from parent to offspring are randomly assigned at conception similar to how a randomized controlled trial assigns people to groups,” said Vincent Millischer, MD, PhD, Medical University of Vienna and co-first author of the study in the KCL news release.

“In our study, the groups are defined by their genetic propensity to different blood protein levels, allowing an assessment of causal direction from high blood protein levels to COVID-19 severity whilst avoiding influence of environmental effects,” he added. 

The scientists selected genetic variants, known as single nucleotide polymorphisms, that were strongly associated with blood protein levels. They then performed their analysis using Mendelian randomization to test the causal associations of those blood proteins with the development of severe COVID-19 infections.

“Mendelian randomization uses genetic variants associated with a trait [e.g., protein level] and measures their causal effect on disease outcomes, [avoiding] environmental confounding factors, such as lifestyle, being physically ill, etc.,” Alish Palmos, PhD, told Medical News Today. Palmos is a Postdoctoral Research Associate at King’s College London’s Social, Genetic, and Developmental Psychiatry Center and co-first author of the study.

Blood Groups Linked to COVID-19 Hospitalization, Death

One of the most important findings of the KCL research is a causal association between COVID-19 severity and an enzyme called ABO, which determines blood type. This discovery suggests that blood groups perform an instrumental role in whether individuals develop severe forms of the illness. 

“The enzyme helps determine the blood group of an individual and our study has linked it with both risk of hospitalization and the need of respiratory support or death,” said Christopher Hübel, PhD, Postdoctoral Research Associate, King’s College and co-last author of the study in the press release. “Our study does not link precise blood group with risk of severe COVID-19, but since previous research has found that proportion of people who are group A is higher in COVID-19 positive individuals, this suggests that blood group A is more likely candidate for follow-up studies.” 

The KCL researchers uncovered several compelling findings regarding blood proteins and COVID-19, including:

  • The discovery of six blood markers that were significantly associated with an elevated risk of hospitalization.
  • The discovery of nine blood markers that were significantly associated with a decreased risk of hospitalization.
  • Consistent results indicating hospitalization being significantly associated with decreased levels of macrophage inflammatory protein.
  • Five blood markers associated with the need for respiratory support or death.
  • Eight blood markers causally associated with a statistically significantly decreased risk of need for respiratory support or death.
  • Consistent results with respiratory support or death being significantly causally associated with decreased levels of neprilysin.

Developing New COVID-19 Treatments and Preventative Therapies

“What we have done in our study is provide a shortlist for the next stage of research,” said Gerome Breen, PhD, in the KCL news release. Breen is Professor of Psychiatric Genetics at King’s College London’s Institute of Psychiatry, Psychology and Neuroscience, and co-last author of the study.

“Out of 1000s of blood proteins we have whittled it down to about 14 that have some form of causal connection to the risk of severe COVID-19 and present a potentially important avenue for further research to better understand the mechanisms behind COVID-19 with an ultimate aim of developing new treatments but potentially also preventative therapies,” he added. 

Further research and clinical investigation are needed to validate the King’s College London researchers’ findings. However, their insights could result in new clinical laboratory tests and personalized treatments for COVID-19.

JP Schlingman

Related Information:

Genetic Study Reveals Causal Link Between Blood Type and COVID Severity

Proteome-wide Mendelian Randomization Identifies Causal Links Between Blood Proteins and Severe COVID-19

New Research Suggests a Causal Link Between Blood Group and Severe COVID-19

Researchers Identify Six Proteins Linked with Severe COVID-19

COVID: Risk of Severe Disease Could be in Your Blood, New Research Finds

COVID-19 Severity: Blood Group May Influence Risk

A Two Minute Primer on Mendelian Randomization

University of Washington Researchers Develop Home Blood Clotting Clinical Laboratory Test That Uses a Smartphone and a Single Drop of Blood

UW scientists believe their at-home test could help more people on anticoagulants monitor their clotting levels and avoid blood clots

In a proof-of-concept study,researchers at the University of Washington (UW) are developing a new smartphone-based technology/application designed to enable people on anticoagulants such as warfarin to monitor their clotting levels from the comfort of their homes. Should this new test methodology prove successful, clinical laboratories may have yet one more source of competition from this at-home PT/INR test solution.

PT/INR (prothrombin time with an international normalized ratio) is one of the most frequently performed clinical laboratory blood tests. This well-proven assay helps physicians monitor clotting in patients taking certain anticoagulation medications.

However, the process can be onerous for those on anticoagulation drugs. Users of this type of medication must have their blood tested regularly—typically by a clinical laboratory—to ensure the medication is working effectively. When not, a doctor visit is required to adjust the amount of the medication in the bloodstream.

Alternatively, where a state’s scope of practice law permits, pharmacists can perform a point-of-care test for the patient, thus allowing the pharmacist to appropriately adjust the patient’s prescription.

Though in the early stages of its development, were the UW’s new smartphone-based blood clotting test to be cleared by the federal Food and Drug Administration (FDA), then users would only need to see a doctor when their readings went and stayed out of range, according to Clinical Lab Products (CLP).

The UW researchers published their findings in the journal Nature Communications, titled, “Micro-Mechanical Blood Clot Testing Using Smartphones.”

Enabling Patients to Test Their Blood More Frequently

More than eight million Americans with mechanical heart valves or other cardiac conditions take anticoagulants, and 55% of people taking those medication say they fear experiencing life-threatening bleeding, according to the National Blood Clot Alliance.

They have reason to be worried. Even when taking an anticoagulation drug, its level may not stay within therapeutic range due to the effects of food and other medications, experts say. 

“In the US, most people are only in what we call the ‘desirable range’ of PT/INR levels about 64% of the time. This number is even lower—only about 40% of the time—in countries such as India or Uganda, where there is less frequent testing. We need to make it easier for people to test more frequently,” said anesthesiologist and co-author of the study Kelly Michaelsen, MD, PhD, UW Assistant Professor of Anesthesiology and Pain Medicine, in a UW news release.

Shyam Gollakota, PhD
“Back in the day, doctors used to manually rock tubes of blood back and forth to monitor how long it took a clot to form. This, however, requires a lot of blood, making it infeasible to use in home settings,” said senior study author Shyam Gollakota, PhD (above), professor and head of the Networks and Mobile Systems Lab at UW’s Paul G. Allen School of Computer Science and Engineering, in the UW news release. “The creative leap we make here is that we’re showing that by using the vibration motor on a smartphone, our algorithms can do the same thing, except with a single drop of blood. And we get accuracy similar to the best commercially available techniques [used by clinical laboratories].” (Photo copyright: University of Washington.)

How UW’s Smartphone-based Blood Clotting Test Works

The UW researchers were motived by the success of home continuous glucose monitors, which enable diabetics to continually track their blood glucose levels.

According to the Nature Communications paper, here’s how UW’s “smartphone-based micro-mechanical clot detection system” works:

  • Samples of blood plasma and whole blood are placed into a thimble-size plastic cup.
  • The cup includes a small copper particle and thromboplastin activator.
  • When the smartphone is turned on and vibrating, the cup (which is mounted on an attachment) moves beneath the phone’s camera.
  • Video analytic algorithms running on the smartphone track the motion of the copper particle.
  • If blood clots, the “viscous mixture” slows and stops.
  • PT/INR values can be determined in less than a minute.  

“Our system visually tracks the micro-mechanical movements of a small copper particle in a cup with either a single drop of whole blood or plasma and the addition of activators,” the researchers wrote in Nature Communications. “As the blood clots, it forms a network that tightens. And in that process, the particle goes from happily bouncing around to no longer moving,” Michaelsen explained.

The system produced these results:

  • 140 de-identified plasma samples: PT/INR with inter-class correlation coefficients of 0.963 and 0.966.
  • 79 de-identified whole blood samples: 0.974 for both PT/INR.

Another At-home Test That Could Impact Clinical Laboratories

The UW scientists intend to test the system with patients in their homes, and in areas and countries with limited testing resources, Medical Device Network reported.

Should UW’s smartphone-based blood-clotting test be cleared by the FDA, there could be a ready market for it. But it will need to be offered it at a price competitive with current clinical laboratory assays for blood clotting, as well as with the current point-of-care tests in use today.

Nevertheless, UW’s work is the latest example of a self-testing methodology that could become a new competitor for clinical laboratories. This may motivate medical laboratories to keep PT/INR testing costs low, while also reporting quick and accurate results to physicians and patients on anticoagulants.

Alternatively, innovative clinical laboratories could develop a patient management service to oversee a patient’s self-testing at home and coordinate delivery of the results with the patient’s physician and pharmacist. This approach would enable the lab to add value for which it could be reimbursed. 

Donna Marie Pocius

Related Information:

Smartphone App Can Vibrate a Single Drop of Blood to Determine How Well It Clots

Blood Coagulation Testing Using Smartphones

Micro-Mechanical Blood Clot Testing Using Smartphones

55% of Americans Taking Blood Thinners Indicate They Fear Suffering from Major Blooding, 73% More Cautious with Routine Activities to Avoid Risk

University of Washington Develops New Blood Clotting Test

Adolescents with Specific Health Conditions Experience Accelerated Aging at Midlife, According to Published Study in New Zealand

Study shows that access to early childhood treatment could have lasting effects and prevent premature adult aging

Researchers in New Zealand have found that people who experienced “daily smoking status, obesity, or a psychological disorder diagnosis” beginning early in life were “biologically older” at midlife than those who did not. The findings suggest that early access to treatments for these health concerns could decrease risk for “accelerated biological aging,” according to the study published in JAMA Pediatrics.

Although these findings do not currently provide a path to a diagnostic test for clinical laboratories, this study is yet another example of how researchers are increasingly using broad swaths of healthcare data to help identify people at risk for certain healthcare conditions.

Such research often presents opportunities for medical laboratories to participate in healthcare Big Data analysis, which in turn helps healthcare providers make precision medicine diagnoses for individual patients.

Study Assessments and Clinical Laboratory Biomarkers

Researchers from the Dunedin Multidisciplinary Health and Development Research Unit (DMHDRU) at University of Otago analyzed the health and behaviors of 910 people (54% men, 46% women) born in Dunedin, New Zealand, between April 1, 1972, and March 31, 1973, through age 45.

The scientists found that participants who had one of three health conditions as an adolescent—obesity, smoking daily, or psychological disorder (anxiety, attention deficit/hyperactivity disorder, depression)—showed advanced signs of aging at age 45 when compared to others without those conditions, CNN reported.

The signs included:

  • Walking 11.2 centimeters per second slower.
  • Brain appears 2.5 years older.
  • Face appears four years older.

At age 11, 13, and 15, the Dunedin Study participants were assessed by pulmonary specialists and others for asthma, cigarette smoking, and obesity, Fox News reported.

Kyle Bourassa, PhD
“There’s a long history of that kind of research in terms of how smoking is damaging at the cellular level but also can result in the kinds of health conditions that we associate with biological aging, like (chronic obstructive pulmonary disease), lung cancer, things like that,” the study’s first author Kyle Bourassa, PhD (above), told CNN. “The hope is if we were to study a cohort now, a much higher proportion of those children and adolescents are actually going to be treated for these things, which will reduce the risk of accelerated aging later in life,” he added. Results of the study may also lead to new clinical laboratory diagnostics. (Photo copyright: Duke University.)

According to an earlier DMHDRU statement, the biomarkers used at this point in the study included:

The researchers also tracked asthma’s effects but concluded it did not contribute to aging, probably due to availability of asthma treatments, the authors wrote in their study published in JAMA Pediatrics, titled, “Association of Treatable Health Conditions During Adolescence with Accelerated Aging at Midlife.”

“Participants who had smoked daily, had obesity, or had a psychological disorder diagnosis during adolescence were biologically older at midlife compared with participants without these conditions. Participants with asthma were not biologically older at midlife compared with those without asthma,” the researchers wrote. These findings led the researchers to certain conclusions about receiving early treatments, CNN reported.

“No participants in this cohort were prescribed stimulants for attention-deficit/hyperactivity disorder, and selective serotonin reuptake inhibitors were not yet in use for adolescent depression and anxiety during the study period. Whereas 81.1% of the adolescents with asthma received some type of treatment, which could have mitigated the implications for biological aging,” the authors wrote in their study.

“Our paper reaffirms that those are important treatments and those kinds of investments younger in the lifespan could net big benefits in terms of both health and the cost of healthcare later on as well,” Kyle Bourassa, PhD, told CNN. Bourassa is the study’s First Author and a clinical psychology researcher and advanced research fellow at the Durham VA Health Care System.

Clinical Laboratories Curate Massive Amounts of Healthcare Data

For pathologists and medical laboratory scientists, the University of Otago study is a reminder that clinical laboratories provide a critical tool to diagnostics professionals: housing, sharing, and analyzing data that contribute to precision medicine diagnoses.

The DMHDRU researchers’ findings also highlight the importance of access to common treatments offered early in life for some people to reduce risk of accelerated aging and disease.

Donna Marie Pocius

Related Information:

Association of Treatable Health Conditions During Adolescence with Accelerated Aging at Midlife

Having Certain Health Conditions in Adolescence May Be Linked with Faster Aging in Adulthood, Study Says

Aging Faster in Adulthood Linked to Health Conditions in Adolescence

;