In-Vitro Diagnostic
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What is Genomic Sequencing and Why Does it Matter for the Future of Health?

What is Genomic Sequencing and Why Does it Matter for the Future of Health? | In-Vitro Diagnostic | Scoop.it

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.

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L'hôpital Foch collabore avec la start-up Surge pour prédire les complications post-chirurgicales

L'hôpital Foch collabore avec la start-up Surge pour prédire les complications post-chirurgicales | In-Vitro Diagnostic | Scoop.it

La start-up Surge a choisi l'hôpital Foch pour tester son algorithme de prédiction des complications post-opératoires à partir d'un échantillon de sang. Un premier essai clinique, mené aux Etats-Unis, a montré des résultats intéressants.

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Portable RT-PCR Molecular Test Detects Dengue Virus with High Accuracy

Portable RT-PCR Molecular Test Detects Dengue Virus with High Accuracy | In-Vitro Diagnostic | Scoop.it

Dengue virus infections can potentially lead to severe outcomes or death in patients. There is currently no approved vaccines and medicine for dengue infection, although researchers have shown that early detection and intervention can bring about much more favorable outcome in patients and relief the burdens of families and health care facilities affected. Nucleic acid tests such as multiplex RT-PCR tests are more accurate and predictive than alternative anti-body-based tests. Now, a new dengue RT-PCR virus test detects the presence of dengue virus infections with a high level of accuracy.

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SARS-CoV-2 Molecular Diagnostics Development | ATCC

SARS-CoV-2 Molecular Diagnostics Development | ATCC | In-Vitro Diagnostic | Scoop.it

The highly pathogenic nature and transmission dynamics of SARS-CoV-2 have necessitated the availability of rapid, robust detection methods to ensure that infected individuals are treated in a timely manner. For SARS-CoV-2 molecular diagnostics manufacturers moving from emergency use authorization (EUA) to 510(k) premarket submission to the US Food & Drug Administration (FDA), robust testing must be performed to demonstrate that the device is safe and effective as well as substantially equivalent to legally marketed devices. To support these validation studies, ATCC provides an extensive array of authenticated and clinically relevant materials for evaluating limit of detection, inclusivity, and cross-reactivity.

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FDA OKs Marketing Of First In Vitro Diagnostic Test To Detect Alzheimer's Disease

FDA OKs Marketing Of First In Vitro Diagnostic Test To Detect Alzheimer's Disease | In-Vitro Diagnostic | Scoop.it

The Lumipulse test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The FDA said the availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer's disease diagnosis.

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Can Cancer Blood Tests Live Up to Promise of Saving Lives?

Can Cancer Blood Tests Live Up to Promise of Saving Lives? | In-Vitro Diagnostic | Scoop.it
It's an open question whether such cancer blood tests — if added to routine care — could improve Americans' health or help meet the White House's goal of cutting the cancer death rate in half over the next 25 years. With advances in DNA sequencing and data science making the blood tests possible, California-based Grail and other companies are racing to commercialize them.
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Early-stage multi-cancer detection using an extracellular vesicle protein-based blood test

Early-stage multi-cancer detection using an extracellular vesicle protein-based blood test | In-Vitro Diagnostic | Scoop.it

Detecting cancer at early stages significantly increases patient survival rates. Because lethal solid tumors often produce few symptoms before progressing to advanced, metastatic disease, diagnosis frequently occurs when surgical resection is no longer curative. One promising approach to detect early-stage, curable cancers uses biomarkers present in circulating extracellular vesicles (EVs). To explore the feasibility of this approach, we developed an EV-based blood biomarker classifier from EV protein profiles to detect stages I and II pancreatic, ovarian, and bladder cancer.

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Acoustic Tweezers Help Characterize Cell Interactions

Acoustic Tweezers Help Characterize Cell Interactions | In-Vitro Diagnostic | Scoop.it

Acoustic tweezer technology involves using sound waves to precisely move, pinch, separate or suspend cell or particles, typically within a microfluidic system. The Duke researchers hope that their version of this technology could assist with cancer research and precision therapy for cancer patients. Acoustic tweezers have significant potential in manipulating cells in very precise ways. This newest inception is incredibly precise and gentle, leading the researchers to call it the Harmonic Acoustics for Non-contact, Dynamic, Selective particle manipulation platform (HANDS platform).

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Rapid home tests are good, but digital health technology is even better at fighting COVID-19

Rapid home tests are good, but digital health technology is even better at fighting COVID-19 | In-Vitro Diagnostic | Scoop.it

Technology companies and device manufacturers should coordinate with public health officials to introduce a new era of precision public health.

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Smart Toilets: A New Medical IoT Device for Passive Urine Analysis

Smart Toilets: A New Medical IoT Device for Passive Urine Analysis | In-Vitro Diagnostic | Scoop.it

A new, low-cost, AI device that can detect and monitor a range of diseases and conditions by analyzing urine in the toilet bowl is hitting the market this month. The KG, from Israeli start-up Olive Diagnostics, sits in a toilet bowl and can detect biomarkers for prostate, ovarian and kidney cancer, as well as heart failure, urinary tract infections and kidney stones.

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Implications of Using Host Response-Based Molecular Diagnostics on the Management of Bacterial and Viral Infections

Implications of Using Host Response-Based Molecular Diagnostics on the Management of Bacterial and Viral Infections | In-Vitro Diagnostic | Scoop.it

Host-based diagnostics are a rapidly evolving field that may serve as an alternative to traditional pathogen-based diagnostics for infectious diseases. Understanding the exact mechanisms underlying a host-immune response and deriving specific host-response signatures, biomarkers and gene transcripts will potentially achieve improved diagnostics that will ultimately translate to better patient outcomes. Several studies have focused on novel techniques and assays focused on immunodiagnostics. In this review, we will highlight recent publications on the current use of host-based diagnostics alone or in combination with traditional microbiological assays and their potential future implications on the diagnosis and prognostic accuracy for the patient with infectious complications. Finally, we will address the cost-effectiveness implications from a healthcare and public health perspective.

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Implementation of the In Vitro Diagnostic Device Regulation

Implementation of the In Vitro Diagnostic Device Regulation | In-Vitro Diagnostic | Scoop.it

The In Vitro Diagnostic Devices Regulation (IVDR 2017/746) is the legislation detailing the requirements which manufacturers have to meet to place in vitro diagnostic devices on the market in the European Union. The Regulation contains detailed requirements that need to be implemented, and will affect all IVD manufacturers, importers, distributors and EU Representatives. The IVDR focusses on devices to be safe and effective, emphasizing pre-market requirements, conformity assessment, post-market-surveillance (PMS), and traceability. This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.

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Smartphone COVID Testing Is 10 Times Cheaper Than a PCR

Smartphone COVID Testing Is 10 Times Cheaper Than a PCR | In-Vitro Diagnostic | Scoop.it

The system is called “smaRT-LAMP” while the app it uses is called Bacticount and the results are said to be as accurate as those from a PCR test.

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Surge détecte les problèmes post-opératoires

Surge détecte les problèmes post-opératoires | In-Vitro Diagnostic | Scoop.it

Ce mercredi 4 mai, Julien Hédou, président de Surge, s'est penché sur les méthodes prédictives descomplications post-opératoires de Surge, dans l'émission 60 Minutes Business présentée par Guillaume Paul.

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A Simple Blood Test Detects Suicidal Tendencies in Individuals with Major Depressive Disorder

A Simple Blood Test Detects Suicidal Tendencies in Individuals with Major Depressive Disorder | In-Vitro Diagnostic | Scoop.it

A gene expression signature found in blood and brain tissue from individuals with major depressive disorder seemed to be associated with the likelihood of development of suicidal behavior. Suicide is a serious global public health problem that accounts for close to 800,000 deaths per year, and since major depressive disorder (MDD) is the most common diagnosis among suicides, identifying those at the highest risk for suicide is a pressing challenge.

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Newly Launched Blood Test Detects Early Signs of Colorectal Cancer - molecular-diagnostics

Newly Launched Blood Test Detects Early Signs of Colorectal Cancer - molecular-diagnostics | In-Vitro Diagnostic | Scoop.it

Colorectal cancer (CRC) is curable if caught early but still remains among the leading cause of cancer-related deaths, with cancer underscreening contributing significantly to the high cancer mortality rate in underserved populations. Barriers associated with currently available methods, such as a colonoscopy or a stool-based test, can make the process unpleasant, time-consuming and difficult to complete. Now, a newly-launched blood-based test for the detection of early-stage CRC intended for adults age 45 and older who are not up to date with recommended screening guidelines, show no symptoms, and are at average risk for CRC, only requires patients to complete a simple blood draw.

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Democratizing Molecular Diagnostics with Custom Lyophilized Reagents

Democratizing Molecular Diagnostics with Custom Lyophilized Reagents | In-Vitro Diagnostic | Scoop.it

Today, most molecular biology laboratories mix reagents at the time of use. This can lead to inefficiencies in the workflow, and contamination or errors in mixing reagents. Many reagents cannot be premixed because they are unstable at room temperatures or could interact with each other, reducing their efficacy. As a result, these reagents need to be manufactured and handled in a “wet” format. Wet reagents are dispensed as liquids in separate tubes and frozen. Thus, they require a cold chain supply system, with expedited shipping on dry ice or frozen gel packs in styrofoam containers and storage in freezers at the customer site.

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Scientists Testify in Holmes Trial: Theranos Tech Was Downright Bad

Scientists Testify in Holmes Trial: Theranos Tech Was Downright Bad | In-Vitro Diagnostic | Scoop.it

Just a few short years ago, biomed startup Theranos was a media darling, and founder Elizabeth Holmes was being lauded as a self-made billionaire. All it took to topple Theranos was an article from John Carreyrou asking some tough questions about the company’s Edison blood testing machine. With the company now shuttered, former CEO Holmes is facing charges for defrauding investors. According to laboratory managers called to testify, Holmes should have known Edison was a dud, Ars Technica reports

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SARS-CoV-2 detected using smartphone biosensor

SARS-CoV-2 detected using smartphone biosensor | In-Vitro Diagnostic | Scoop.it

Although the majority of individuals who are infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will remain asymptomatic, they are still capable of transmitting the virus the others. In addition to the widespread prevalence of asymptomatic carriers, the coronavirus disease 2019 (COVID-19) can also be difficult to diagnose, as those who are asymptomatic often experience symptoms similar to both the flu and pneumonia.

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A pretreatment-free electrical capacitance biosensor for exosome detection in undiluted serum

A pretreatment-free electrical capacitance biosensor for exosome detection in undiluted serum | In-Vitro Diagnostic | Scoop.it

The exosome is considered a useful biomarker for the early diagnosis of cancer. However, pretreatment of samples used in diagnosis is time-consuming. Researchers at Kwangwoon University have fabricated a capacitance-based electrical biosensor that requires no pretreatment of the sample; it is composed of a DNA aptamer/molybdenum disulfide (MoS2) heterolayer on an interdigitated micro-gap electrode (IDMGE)/printed circuit board (PCB) system for detecting exosomes in an undiluted serum sample. The DNA aptamer detects the CD63 protein on the exosome as the biomarker, while the MoS2 nanoparticle enhances electrical sensitivity.

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Roche Medical software and the value of digital health

Roche Medical software and the value of digital health | In-Vitro Diagnostic | Scoop.it

Pioneering technologies can detect the risk of disease, predict how a disease may progress and enable the right treatment decision at the outset. Software solutions that support these tests and devices are becoming an integral part of decision making along the entire continuum of a patient’s health or disease, enabling physicians to make full use ofin vitro diagnostics (IVDs) along the healthcare value chain. Digital health software empowers patients to gain control over chronic conditions by enabling both physicians and patients to monitor treatment progress. And, through its ability to rapidly connect dots between patients, healthcare professionals, evidence-based research and even between biomarkers and disease indicators, digital health provides data-driven results to support life-changing decisions.

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Genomic Sequencing is Pathing the Way to Digital Health

Genomic Sequencing is Pathing the Way to Digital Health | In-Vitro Diagnostic | Scoop.it

Adopting cutting-edge technology, tools and innovation in public health and medicine is no easy task, yet many companies are doing great work contributing to the society and the challenging world that we all live in right now. Among them, MGI, which has been playing a vital role in combating Covid-19, has opened the door to digital health through its highly effective genomics sequencing technologies.

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3D-printed Sensor on Fibre-Optic Probes for Rapid Bacteria Detection

3D-printed Sensor on Fibre-Optic Probes for Rapid Bacteria Detection | In-Vitro Diagnostic | Scoop.it

Our research team first 3D-printed polymer micro- and nano-structures on the tip of an optical fibre by using two-photon polymerisation (2PP), a micro-scale 3D-printing technique that is commercially available (Nanoscribe GmbH, Germany). These micro- and nano-structures then coated with a thin layer of gold (50 nm) to produce the metal surfaces for Raman signal enhancement.

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Molecular diagnostics for CLAD: When and where?

Molecular diagnostics for CLAD: When and where? | In-Vitro Diagnostic | Scoop.it

Improving long-term survival following lung transplantation will require new therapeutic approaches to chronic lung allograft dysfunction (CLAD). While CLAD is predominantly driven by obliterative bronchiolitis pathology, substantial small airways loss is needed to result in the 20% decline in FEV1 that defines this diagnosis. At the same time, several distinct biologic processes can drive FEV1 decline. This diagnostic challenge limits the development of mechanism-specific therapies and clouds prognosis. Thus, there is strong motivation to develop molecular approaches to diagnose and phenotype CLAD.

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Achieving higher safety and throughput in molecular diagnostics

Achieving higher safety and throughput in molecular diagnostics | In-Vitro Diagnostic | Scoop.it

With mutations of pathogen looming, diagnostic methods must detect such mutations and provide a clinical outcome to patients. In today’s environment, beyond just being state-of-the-art, laboratory technology needs to do more than offer high-quality, adaptable, safe workflows, it needs to meet the demand for results on a large scale. Altogether, this can only be achieved with high-quality systems, products and kits that are flexible, safe, and user-friendly, allow scaling-up, and are compatible and customisable to meet each laboratory’s specific needs. MolGen provides laboratories all over the world with technology, systems, products, and kits for molecular biology that enables them to be disruptive and competitive. MolGen envisions that every molecular biology lab will embrace various sorts of automation that provide endless possibilities.

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