In-Vitro Diagnostic

Chronic kidney disease (CKD) affects over 800 million people globally and is often diagnosed too late for effective intervention. Early detection depends on accurate measurement of biomarkers such as creatinine and the urine albumin-to-creatinine ratio (uACR). While urine testing is non-invasive and informative, standard methods are time-consuming, costly, and require specialized facilities. Existing point-of-care devices offer convenience but remain prohibitively expensive or technically complex for many users. As such, there is an urgent need for a robust, affordable, and easy-to-use platform to measure urinary creatinine with clinical precision.

BillionToOne said that since launching its first tests in 2020, over 500,000 patients have been evaluated to date, driving $125 million in annual revenue.

Diagnosing mouth cancer often involves invasive and uncomfortable procedures like biopsies and nasoendoscopy (inserting a flexible tube with a camera into the nose or mouth). However, scientists at the University of Birmingham are paving the way for a more patient-friendly approach – flavored lollipops that could potentially detect mouth cancer. This innovative research has garnered significant support, with Cancer Research UK and the Engineering and Physical Sciences Research Council providing £350,000 in funding.

Five years ago, 23andMe was one of the hottest startups in the world. Millions of people were spitting into its test tubes to learn about their ancestry. Oprah had named its kit one of her favorite things; Lizzo dressed up as one for Halloween; Eddie Murphy name-checked the company on “Saturday Night Live.” 23andMe went public in 2021 and its valuation briefly topped $6 billion. Forbes anointed Anne Wojcicki, 23andMe’s chief executive and a Silicon Valley celebrity, as the “newest self-made billionaire.”

Now Wojcicki’s self-made billions have vanished. 23andMe’s valuation has crashed 98% from its peak and Nasdaq has threatened to delist its sub-$1 stock. Wojcicki reduced staff by a quarter last year through three rounds of layoffs and a subsidiary sale. The company has never made a profit and is burning cash so quickly it could run out by 2025.

We report an impedimetric sensor based on an interdigitated electrode array with electrode digits located at the bottom of microcapillaries formed in silicon dioxide which is used to monitor protamine-heparin interactions. Modification of the active sensor surface with protamine, a cationic protein used as a high affinity heparin antagonist, permits to register protamine-heparin complex formation as changes in the surface conductivity determined from the sensor impedance measured in an electrolyte solution.

Tattoo electronics, flexible patches that mount directly onto the skin with the ease and flexibility of a temporary tattoo, have foreseen remarkable application potentials in personalized healthcare monitoring and human-machine interfaces. Documented tattoo electronics mostly have an on-skin form factor to date. Using dermal tattoos for in vivo diagnostics presents an unexplored paradigm. Here, we extend the application scenario of “tattoo electrodes” from an on-skin fashion to an actual under-skin configuration, enabled by a highly soft, conductive, and biocompatible polymer matrix.

Scientists at Penn State have developed a microneedle bandage that can rapidly stop bleeding. Uncontrolled bleeding following a traumatic injury is a major cause of death in the young, and developing new medical technologies that can rapidly stop bleeding would be highly beneficial. This bandage contains an array of biodegradable and biocompatible microneedles made using a gelatin methacryloyl biomaterial. The device also contains silicate nanoplatelets that give it its hemostatic properties, and the needle structure increases the surface area for blood contact and helps to bind the bandage to the injured tissue.

Véritable révolution dans le suivi de santé quotidien, Withings U-Scan est conçu comme une plate-forme modulaire composée d'un lecteur en forme de galet avec des cartouches d'analyse interchangeables qui évaluent des biomarqueurs spécifiques sans qu'il soit nécessaire de faire des prélèvements d’échantillons ou de manipuler des bandelettes urinaires. Grâce à une synchronisation automatique avec l'application Health Mate, il fournit une multitude d'informations exploitables basées sur une mesure quotidienne.

Myocarditis, or inflammation of the heart muscle, is a difficult condition to diagnose. Now, the discovery of a molecular signal in the blood could pave the way for the first blood test to be used for diagnosing myocarditis within as little as a year.

The global outbreaks of infectious diseases have significantly driven an imperative demand for rapid and accurate molecular diagnostics. Nucleic acid amplification tests (NAATs) feature high sensitivity and high specificity; however, the labor-intensive sample preparation and nucleic acid amplification steps remain challenging to carry out rapid and precision molecular diagnostics at home.

EXOSOMES are biological nano-vesicles involved in cell communication. Their discovery has revolutionized medicine. France is third in the world in terms of the number of clinical studies related to innovative diagnostics around these exosomes. Half of them take place in New Aquitaine. However, exosomes are still largely unexploited due to a lack of suitable tools allowing them to be characterized in real time according to their content.
The ExoFlow project, funded by Nouvelle-Aquitaine region, aims to design and manufacture an innovative scientific instrument to characterize biological nano-objects such as exosomes or viruses in real time. The partners, ALPhANOV, Chrysa-link, the SATT Aquitaine deep tech incubator, the LP2N laboratory and the Paul Pascal Research Center will have 2 years to achieve these objectives.

DNA is the fundamental biological unit of data storage. It comprises long sequences of base pairs (bps), each of which represent one of four values (A, T, C or G), similar in the way binary digit (bit) data storage is used in computing. Different combinations of these base pairs encode the blueprints for constructing every molecular machine that life needs to function.

The detection and quantification of protein biomarkers in interstitial fluid is hampered by challenges in its sampling and analysis. Here we report the use of a microneedle patch for fast in vivo sampling and on-needle quantification of target protein biomarkers in interstitial fluid. We used plasmonic fluor—an ultrabright fluorescent label—to improve the limit of detection of various interstitial fluid protein biomarkers by nearly 800-fold compared with conventional fluorophores, and a magnetic backing layer to implement conventional immunoassay procedures on the patch and thus improve measurement consistency.

The FDA has launched a project with the Bill and Melinda Gates Foundation to help aid the development of breath-based diagnostics for detecting diseases more easily among underserved populations. The TB-focused project with the FDA follows up on the Gates Foundation's interest in breath biopsy tests developed by Owlstone Medical.

The potential of liquid biopsy for the prognosis and diagnosis of diseases is unquestionable. Within the evolving landscape of disease diagnostics and personalized medicine, circulating microRNAs (c-miRNAs) stand out among the biomarkers found in blood circulation and other biological fluids due to their stability, specificity, and non-invasive detection in biofluids. However, the complexity of human diseases and the limitations inherent in single-marker diagnostics highlight the need for a more integrative approach. It has been recently suggested that a multi-analyte approach offers advantages over the single-analyte approach in the prognosis and diagnosis of diseases. In this review, we explore the potential of combining three well-studied classes of biomarkers found in blood circulation and other biofluids—miRNAs, DNAs, and proteins—to enhance the accuracy and efficacy of disease detection and monitoring. Initially, we provide an overview of each biomarker class and discuss their main advantages and disadvantages highlighting the superiority of c-miRNAs over the other classes of biomarkers.

Researchers have pioneered a method to measure ocular aging by studying proteins in eye fluid. Using artificial intelligence, they crafted an “eye-aging clock” from 26 out of nearly 6,000 proteins which can forecast aging. Their findings can lead to more personalized medical treatments and help in understanding disease triggers. The team aims to employ this method to other body fluids, enhancing drug development for various ailments.

Skin cancer is a prevalent cancer in the US. Detecting it is a pressing need. The FDA granted breakthrough device designation to The DermaSensor, a device that helps identify suspicious lesions for skin cancer. The DermaSensor is a non-invasive device that works by spectrometry. This device captures the substructure image of the cells and, together with software powered by machine learning, yields in just seconds an analysis of the nature and characteristics of the lesion.

The results indicate that the system predicts troponin-I levels with about 90% accuracy. In addition, the findings correlated well with clinical evidence of a heart attack; people with abnormal troponin levels as measured by the device were about four times as likely to have an obstructed artery compared to people with a negative troponin result as measured by the device. Download source article at: https://www.researchgate.net/publication/369076645_A_Novel_Breakthrough_in_Wrist-Worn_Transdermal_Troponin-I-Sensor_Assessment_for_Acute_Myocardial_Infarction/fulltext/64088c2f0d98a97717ec869f/A-Novel-Breakthrough-in-Wrist-Worn-Transdermal-Troponin-I-Sensor-Assessment-for-Acute-Myocardial-Infarction.pdf

Researchers at Penn State designed a pop-up electrode for brain monitoring and other applications requiring neural interfacing. The pop-up design starts life as a folded two-dimensional structure with a rigid outer coating that makes it easy to insert into the brain. Once in place, the hard coating dissolves, revealing a softer and more flexible material that is less likely to cause tissue damage. The device can unfold, like the structures in children’s pop-up books, to form a surface electrode array and four penetrating shanks that can measure signals from deeper within the neural tissue. The researchers hope that the device will help to drive advanced medical technologies, such as brain computer interfaces.

The photoacoustic patch comprises several different ultrasonic transducers that detect acoustic waves and vertical-cavity surface-emitting laser (VCSEL) diodes. Both types are integrated on a common substrate composed of an elastomeric matrix and are linked to each other by coiled metal electrodes.

A new study aims to evaluate the performance of a non-invasive, quantitative real-time PCR (qPCR) assay designed to detect two DNA methylation biomarkers in urine specimens from patients suspected of having bladder cancer.

The assay amplifies hallmark nucleic acid signatures and allows for rapid identification of a viral pathogen. Cleverly, the device is designed with rapid mass testing in mind, and is conceived as first analyzing pooled samples from multiple individuals, and then automatically testing individual samples if the pooled sample yields a positive result. The result is a technology that can quickly assess large groups of people, with less reagents, expense, and time than conventional diagnostic approaches.

Inspiré par le combat de sa mère, qui a subi deux cancers du sein et une double mastectomie, l’étudiant a créé un soutien-gorge capable de détecter la maladie. « Au départ, la tumeur avait la taille d’un grain de riz. En moins de six mois, ses dimensions étaient devenues celles d’une balle de golf. La maladie a été diagnostiquée trop tard, et ma mère a perdu ses deux seins, presque sa vie », s’est-il confié à l’entreprise Higia Tech.