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Clinical Laboratories and Pathology Groups

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Nutromics Receives $14M for Development of Lab-on-a-Patch DNA Sensor Platform That Transmits Biometric Data in Real Time from Interstitial Fluid

Similar health monitoring devices have been popular with chronic disease patients and physicians who treat them; this technology may give clinical laboratories a new diagnostic tool

There is an ever-increasing number of companies working to develop lab testing technologies that would be used outside of the traditional clinical laboratory. One such example is Nutromics, an Australia-based medical technology company which recently announced it has raised US $14 million to fund its new lab-on-a-patch platform, according to a company press release.

Nutromics’ lab-on-a-patch device “uses DNA sensor technology to track multiple targets in the human body, including disease biomarkers and hard-to-dose drugs,” according to MobiHealthNews. Notably, Nutromics’ technology uses interstitial fluid as the sample source.

The funding, which is earmarked for clinical trials, research, and continued development of the technology, comes from health technology company Dexcom (through the Dexcom Ventures capital fund), VU Venture Partners, and global investment management firm Artesian Investments.

Nutromics raised $4 million last year to support a manufacturing facility and an initial human clinical trial of its “continuous molecular monitoring (CMM) platform technology that is able to track multiple targets in the human body via a single wearable sensor. The platform provides real-time, continuous molecular-level insights for remote patient monitoring and hospital-at-home systems,” MobiHealthNews reported.

Peter Vranes

“We are aiming to cause a paradigm shift in diagnostic healthcare by essentially developing a lab-on-a-patch. A lack of timely and continuous diagnostic insights can strongly impact outcomes when dealing with critical disease states. With this strategic industry and VC (venture capital) investment in us, we see more confidence in our technology and hope to accelerate our growth,” said entrepreneur and chemical engineer Peter Vranes (above), co-founder and CEO of Nutromics, in a press release. Clinical laboratory leaders have watched similar biometric monitoring devices come to fruition. (Photo copyright: Nutromics.)


How Nutromics’ Lab-on-a-Patch Works

“Our technology is, in fact, two technologies coming together—a marker and needle. What that does is give us access to fluid under your skin called interstitial fluid. If you’re going to measure something continuously, that’s a really good fluid [to measure],” Vranes told Outcomes Rocket.

Vranes calls the system’s aptamer-based sensor platform technology the “jewel in the crown.” An aptamer is a short sequence of artificial DNA or RNA that binds a specific target molecule. Nutromics’ aptamer sensor, Vranes said, enables targeting of analytes, unlike continuous glucose monitors (CGMs). 

“[CGMs] are limited to metabolites—things that are already in the body like glucose and lactate. We’re not limited to those. We can do a whole range of different targets. And what that gives us is a ‘blue ocean’ opportunity to go in and solve problems in areas that other technologies just can’t solve,” Vranes said.

Nutromics plans to develop multiple aptamer-based sensors that measure a variety of analytes in interstitial fluid, Medtech Insight noted.

Nutromics' wearable DNA sensor lab-on-a-patch

Nutromics’ wearable DNA sensor lab-on-a-patch technology (above) enables monitoring of multiple targets, including disease biomarkers and some medications, MobiHealthNews explained. The wearable patch contains microneedles that painlessly access interstitial fluid under the skin. Collected data is wirelessly transmitted to a software application and integrates with consumer health software and provider platforms, according to Nutromics. Medical laboratories could have a role in collecting this data and adding it other test results from patients using the wearable patch. (Photo copyright: Nutromics.)

Initial Launch Will Include Antibiotic Monitoring

Nutromics expects to initially launch therapeutic monitoring of vancomycin, a glycopeptide antibiotic medication used to treat various bacterial infections. The company says 60% of doses for this prescription antibiotic are not within therapeutic range.

The smart patch enables clinicians to give patients medicine “at the right dose and at the right time,” Sophie Stocker, PhD, a senior hospital scientist at St. Vincent’s Hospital Sydney and Senior Lecturer, University of Sydney School of Pharmacy in New South Wales, Australia, told MobiHealthNews.

Nutromics also envisions opportunity in acute kidney injury (AKI).

Other Research Using Microneedle Patch to Sample Interstitial Fluid

Nutromics is not alone in its use of a microneedle patch to access interstitial fluid (ISF) for diagnostics. In “Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid,” Dark Daily reported how 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.

Scientists at the Georgia Institute of Technology and Emory University in Atlanta have been studying interstitial fluid as a source of biomarkers, as compared to blood, for years.

“Interstitial fluid originates in the blood and then leaks out of capillaries to bring nutrients to cells in the body’s tissues. Because interstitial fluid is in direct communication with the cells, it should have information about the tissues themselves beyond what can be measured from testing the blood,” said Mark Prausnitz, PhD, Regents Professor and J. Erskine Love Jr. Chair, Georgia Tech School of Chemical and Biomolecular Engineering, in a 2020 news release announcing results of human trials of microneedle-based ISF sampling.

The scientists published their findings in the journal Science Translational Medicine titled, “Sampling Interstitial Fluid from Human Skin Using a Microneedle Patch.”

“We sampled interstitial fluid from 21 human participants and identified clinically relevant and sometimes distinct biomarkers in interstitial fluid when compared to companion plasma samples based on mass spectrometry analysis,” the scientists wrote.

Clinical laboratory leaders and pathologists will find it useful to monitor the development of diagnostics for use outside the lab. Nutromics is an example of a company developing wearable health technology that painlessly gathers data for lab tests to be conducted in point-of-care and near-patient settings.     

—Donna Marie Pocius

Related Information:

Nutromics Raises US$14 Million For Its Ground-breaking Wearable Diagnostic Platform

Lab-on-a-Patch Maker Nutromics Scores $14M From Dexcom Ventures, Others

Peter Vranes, Co-founder of Nutromics, Nutromics Smart Patch—The Next Evolution of the Continuous Glucose Monitor

Nutromics Raises $14m as Dexcom Signals Move into Wider Sensing Capabilities

Australian Medtech Start-up Nutromics Bags $4M in Pre-Market Funding for Continuous Monitoring Device

Extraction of Largely Unexplored Bodily Fluid Could be a New Source of Biomarkers

Sampling Interstitial Fluid from Human Skin Using a Microneedle Patch

Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid

Japanese Researchers Create Inexpensive Palm-Size Microfilter That Captures Circulating Tumor Cells from Minute Amounts of Blood

Its low cost may advance liquid biopsy cancer testing used by anatomic pathologists and improve outcomes by speeding time to diagnosis and treatment

Researchers in Japan say they have created a circulating tumor cell (CTC) detection solution that is inexpensive and easy to run. Such a device would be of huge interest to investors and companies wishing to develop clinical laboratory tests that use circulating tumor cells in the blood to identify patients with cancer.

In a proof-of-concept study, researchers at Kumamoto University (KU) in Japan have developed and tested a microfilter device they claim can separate and capture CTCs in blood without large equipment, a KU news release reported.

According to Medgadget, the device is an “inexpensive, convenient, and highly sensitive filter that can successfully work in samples containing as few as five tumor cells in one milliliter of blood and does not require expensive equipment or reagents, unlike certain pre-existing cell capture technologies.”

This Technology Could Give Pathologists a Less-Invasive Cancer Test

As medical laboratory scientists and anatomic pathologists know, a CTC test is less invasive than tissue biopsy, which benefits patients. Furthermore, such a CTC test may enable earlier detection of cancer and start of treatment improving odds for success.

Still, there are many pitfalls to overcome when the challenge is to detect cancer cells in a milliliter (about .03 fluid ounce) of blood. As Medgadget put it, “A needle in a haystack doesn’t even come close.”

“Cancer cell count in the blood of cancer patients is extremely low. If these cells are easily detectable, cancer diagnosis may be possible by simply using a blood test, thus reducing patient burden,” the researchers wrote in their paper.

The KU scientists published their findings in Talanta, the international journal of pure and applied analytical chemistry, titled, “Detection of Cancer Cells in Whole Blood Using a Dynamic Deformable Microfilter and a Nucleic Acid Aptamer.”

Yuta Nakashima, PhD

“This work demonstrates that our microfilter device can accurately detect trace amounts of cancer cells in blood,” said study leader Yuta Nakashima, PhD (above), Associate Professor, Department of Mechanical System Engineering at Kumamoto University, in the news release. “We expect it will be adopted for cancer diagnosis and treatment, including for early diagnosis of cancers that cannot be detected by imaging like CT and PET scans, post-operative follow-up, recurrence monitoring, and tailor-made treatments. In the future, we plan to use blood samples donated by cancer patients to verify the practical and clinical application of the method,” he added. Were it to become available, such a CTC test would be a boon for clinical laboratories and anatomic pathologists engaged in cancer diagnostics and treatment. (Photo copyright: Kumamoto University.)

How Does the CTC Filter Device Work?

The KU scientists created a palm-size “cancer detection device using a microfilter and nucleic acid aptamer,” the paper said, adding:

  • The microfilter was made with photolithography, electroforming, and three-dimensional (3D) printing.
  • It includes slits to enable a deformation with force of blood pumping through the device.
  • As blood flows over the microfilter, cancer cells bind to the nucleic acid aptamer.
  • Force of blood flow opens microfilter slits, pushing away the healthy cells.
  • Cancer cells are left on the microfilter.

To test the microfilter the researchers used one milliliter of blood that was “spiked with cancer cells,” according to the paper. Findings include:

  • Detection of five CTCs in one milliliter of blood. 
  • Blood cell removal rate of 98% suggested “no blood cells were absorbed by the microfilter,” the news release said.
  • The method “showed higher accuracy than the CellSearch System,” the Talanta paper noted.

The KU research team compared their microfluidic device to CellSearch, an FDA-cleared system for detecting CTCs from a blood sample. 

CellSearch enables “identification, isolation, and enumeration of CTCs of epithelial origin,” according to Menarini Silicon Biosystems of Castel Maggiore, Italy. It works from a blood sample of 7.5 millimeters with “high level of sensitivity and specificity,” notes the company’s website.

According to Menarini, labs offering CellSearch CTC testing include:

CTC Tests Progress, But More to Do

The UK scientists admit that their research needs further study. Nakashima indicated he plans to test blood samples donated by cancer patients in subsequent device trials.

However, a separate CTC study published in Oncology Letters, titled, “Detection of Circulating Tumor Cells: Advances and Critical Concerns,” suggested that CellSearch and another CTC assay, Gilupi CellCollector, are “limited in their clinical application, largely due to their low sensitivity.”  

“Although great progress has been made, there is a long way to go before CTC-based liquid biopsy is widely used as a routine test in clinical application,” the authors of that study noted.

Nevertheless, even with more to do, liquid biopsy testing has come a long way, as multiple Dark Daily eBriefs reported over the years.

If the KU scientists succeed in bringing to market a microfilter that can reduce the cost of CTC detection by clinical laboratories while also improving cancer diagnostics, that will have a huge impact on cancer patients and is worthy of clinical laboratory leaders’ attention.    

Donna Marie Pocius

Related Information:

Microfilter Device Capable of Detecting Trace Amounts of Cancer Cells in One mL of Blood

Inexpensive Filter Isolates Circulating Tumor Cells

Detection of Cancer Cells in Whole Blood Using a Dynamic Deformable Microfilter and a Nucleic Acid Aptamer

Detection of Circulating Tumor Cells: Advances and Critical Concerns

Dark Daily: Liquid Biopsy