An AI-generated image depicts nanosensors for disease detection. (Credit: Gefo/AdobeStock)

Nanosensors are transforming the field of disease detection by offering unprecedented sensitivity, precision, and speed in identifying biomarkers associated with various health conditions. These tiny sensors, often built at the molecular or atomic scale, can detect minute changes in biological samples, enabling the early diagnosis of diseases such as cancer, infectious diseases, and neurological disorders.

The integration of nanosensors into diagnostic platforms allows for noninvasive, real-time monitoring, and the potential for personalized medicine. This technology is paving the way for more accurate, efficient, and accessible healthcare solutions, ultimately improving patient outcomes and transforming how diseases are diagnosed and managed.

Companies at the forefront of this technology are developing nanosensors that leverage nanotechnology to create highly sensitive and precise diagnostic tools. Key players include Nanomix, Owlstone Medical, Abionic, Roswell Biotechnologies, and YourBio Health.

Point-of-Care Diagnostics

Nanomix’s diagnostics rapidly detect a variety of diseases and medical conditions directly at the point of care, eliminating the need for traditional, time-consuming laboratory testing. The core of the company’s technology lies in their proprietary nanotechnology-based biosensors, which are designed to detect specific biomarkers in blood, plasma, or other bodily fluids. These sensors are integrated into hand-held devices that are easy to use and can provide results in a matter of minutes.

Owlstone’s Breath Biopsy platform works by capturing and analyzing VOCs that are exhaled in breath. (Credit: Owlstone Medical)

Nanomix’s products are particularly valuable in critical care settings, where rapid diagnosis can significantly impact patient outcomes. The company’s eLab analyzer is a portable device capable of performing multiple tests from a single drop of blood. This device can be used for various applications, including the detection of infectious diseases, cardiac markers, and other critical biomarkers, making it a versatile tool in emergency and critical care environments.

Nanomix’s innovations are helping to make diagnostics more accessible, faster, and less dependent on traditional lab infrastructure, ultimately contributing to more timely and effective medical care.

According to the company, its mobile eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Its S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single sample. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration.

Breath Biopsy

Owlstone Medical specializes in developing noninvasive breath-based diagnostics, a technology known as breathomics. Their primary focus is on creating tools that can detect diseases such as cancer, asthma, and other respiratory conditions through the analysis of volatile organic compounds (VOCs) in a person’s breath.

The company’s flagship product is the Breath Biopsy platform, which works by capturing and analyzing VOCs that are exhaled in breath. These VOCs can serve as biomarkers for specific diseases because they are produced by the body’s metabolic processes. By detecting these biomarkers, the technology is designed to diagnose diseases early, monitor disease progression, and assess treatment efficacy.

The abioSCOPE works by using nanofluidic technology combined with a digital immunoassay system. (Credit: Abionic)

The Breath Biopsy platform includes a device that collects breath samples and a range of analytical tools to identify and quantify the VOCs present. This approach offers a noninvasive, pain-free, and potentially faster alternative to traditional diagnostic methods, such as blood tests or tissue biopsies. The technology is being applied in various clinical trials and research studies, with the goal of revolutionizing early detection and personalized medicine by providing a new way to understand and monitor health through breath analysis.

In April 2024, Owlstone secured funding from the Bill & Melinda Gates Foundation. The $5 million equity investment will advance Owlstone’s Breath Biopsy platform and $1.5 million in grant funding will help the company develop breath-based diagnostics and identify breath biomarkers for tuberculosis (TB) and human immunodeficiency viruses (HIV).

With support from the foundation, Owlstone is interested in developing new cost-effective detection technologies for volatile organic compounds (VOCs) that could serve as markers of diseases that disproportionately affect the developing world. With the new funding, Owlstone says it is seeking to understand whether this approach is suitable for TB and HIV detection and to explore a path by which breath-based testing could be deployed for rapid screening and earlier diagnosis.

“Early diagnosis is a critical determinant of health outcomes,” says Billy Boyle, co-founder and CEO at Owlstone Medical. “By enabling swift and non-invasive detection of disease, breath analysis has the potential to save lives and dramatically reduce the burden of illness in resource-constrained settings. This investment by the Gates Foundation is a testament to how Owlstone is uniquely positioned to transform infectious disease diagnosis through our Breath Biopsy platform. The funds will accelerate both the discovery and validation of VOC biomarkers, and the development of a fieldable, low cost, simple to use device.”

The $5 million equity investment will support advancements of the Breath Biopsy platform, including expansion of the Breath Biopsy VOC Atlas (1) database and for development of a remote-use real-time breath analyzer. This component of the funding will be the first time that the foundation has taken an equity position in a breath diagnostics company.

The $1.5 million in grant funding to support the identification of breath biomarkers will be used across two projects:

TB: In partnership with the University of Cape Town, South Africa, Owlstone aims to identify a panel of on-breath candidate VOC biomarkers that differentiate TB subjects from healthy controls and to develop breath diagnostic approaches based on exploiting the metabolic features of TB using in vitro approaches.

HIV: Working with investigators from Imperial College, UK, and Oxford University, UK, Owlstone will analyze VOCs from blood samples from subjects with HIV and will work to identify a panel of on-breath candidate VOC biomarkers that correlate with HIV viral load.

In both areas, the data collected will also be used to further populate Owlstone’s Breath Biopsy VOC Atlas.

In Vitro Diagnostics

Abionic’s technology is particularly valuable in emergency situations where rapid diagnosis can be lifesaving, such as in the detection of sepsis, allergies, and cardiovascular conditions. The speed and portability of the company’s abioSCOPE® system enables healthcare providers to make quicker decisions, potentially improving patient outcomes in critical care environments.

The abioSCOPE® works by using nanofluidic technology combined with a digital immunoassay system. The platform requires only a small blood sample, which is placed on a disposable cartridge. Inside the cartridge, nanofluidic technology allows the sample to flow through microscopic channels, where specific biomarkers are captured and detected. The results are then analyzed and displayed on the abioSCOPE® device, providing clinicians with critical information within minutes.

In 2023, Abionic and biomedical technology company LASCCO SA signed a licensing agreement with Fapon for the use of the pancreatic stone protein (PSP) biomarker for sepsis diagnosis in China. Under this agreement, Fapon will develop and commercialize PSP on its chemiluminescent immunoassay (CLIA) analyzer within the Chinese market.

This strategic partnership was designed to remove barriers to early sepsis diagnosis. Performing PSP testing on high-risk individuals can flag potential sepsis before the onset of clinical symptoms. Early detection enables to rule in / rule out for critical care, to treat in a timely manner which is tightly linked to reduced risks of organ dysfunction and improved survival rates, and to optimize allocation of medical resources.

DNA Sequencing

YourBioHealth’s flagship product, Touch-Activated Phlebotomy (TAP), is designed for virtually painless and minimally invasive blood collection. (Credit: YourBio)

Roswell Biotechnologies, based in San Diego, CA, uses molecular electronics for DNA sequencing and other applications in biosensing. Their groundbreaking work revolves around the development of the Roswell Molecular Electronics (ME) platform, which integrates molecular electronics with semiconductor technology to create precise biosensors at the molecular level.

The company’s technology applies single-molecule detection, where electronic sensors are used to directly measure biological interactions in real-time. The Roswell ME platform functions by embedding molecules into an electronic circuit. As these molecules interact with biological samples, their electrical properties change, and these changes are detected and measured by the platform. This approach allows for ultra-sensitive detection of biological events, such as DNA sequencing, at an unprecedented scale and speed.

The primary focus of their platform is to take DNA sequencing to a new level by making it faster, more accurate, and more accessible. By applying molecular electronics, Roswell is looking to overcome the limitations of traditional sequencing methods, potentially enabling advances in personalized medicine and diagnostics.

According to the company, the company’s chip reads a multitude of molecules — enzymes, DNA, RNA, proteins, and small molecules — and for the first time, provides direct real-time electrical detection of single-molecule events on-chip. Designed to overcome the enduring scaling limitations of genomic sequencing technologies, the Roswell ME Chip Platform is designed to significantly reduces genomic sequencing’s cost and complexity to advance basic and translational research, precision medicine, molecular diagnostics, environmental surveillance, and digital DNA data storage.

Blood Collection

YourBioHealth, formerly known as Seventh Sense Biosystems, develops innovative blood collection devices. Their flagship product, Touch-Activated Phlebotomy (TAP), is designed for virtually painless and minimally invasive blood collection. The device uses a combination of microneedles and vacuum technology to draw blood from the upper layers of the skin, making the process more comfortable and less intimidating compared to traditional venipuncture. The collected blood can then be used for various diagnostic tests, making it a convenient option for both patients and healthcare providers.

With this platform, the company wants to improve the experience of blood sampling, especially for patients who have difficulty with conventional blood draws. The TAP device is particularly useful in point-of-care settings, home testing, and for patients requiring frequent monitoring.

In July 2024, O’Ryan.Health launched two, parent-led observational studies involving the in-home collection of pediatric blood from children. Juvenile Dermatomyositis (JDM) is an ultra-rare pediatric autoimmune disorder. O’Ryan partnered with YourBio Health, enabling parents to safely and efficiently sample their children’s blood without having to travel to a medical facility.

The institutional review board approved study involves healthy children and children with a JDM diagnosis. Capillary blood is drawn on a predetermined schedule using virtually painless TAP Micro devices. Guided by animated Superhero Scientists and comic book “mission reports” of their results, children take an active role in their healthcare journey and learn about their immune health.

Summary

Nanosensors are poised to change the future of disease detection by providing unprecedented accuracy, speed, and sensitivity in identifying biomarkers associated with various health conditions. Operating at the molecular or atomic scale, these sensors can detect minuscule changes in biological samples, which is critical for the early diagnosis of diseases like cancer, infectious diseases, and neurological disorders. The integration of nanosensors into diagnostic tools allows for noninvasive, real-time monitoring, paving the way for personalized medicine. As companies continue to leverage nanotechnology, they are enabling more precise and accessible solutions, ultimately improving patient outcomes.

This article was written by Sherrie Trigg, Editor and Director of Content, Medical Design Briefs. She can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..