Roche is the Nr. 1 in vitro diagnostics company in the world. We believe that all good treatments depend on timely, fast and precise diagnosis. Our goal is to make our diagnostics products even faster and more reliable, for doctors, laboratories, and patients. And we constantly innovate and develop new tests to obtain results for conditions which could not be tested for previously, that can help doctors make better decisions. For the benefit of patients around the world, and to help alleviate healthcare cost burden.
IVD reagent industry is an emerging industry in China, the start is late and the development is relatively backward compares with occidental countries. According to the data provided by IVD Special Committee, there are 300 to 400 IVD reagent manufacturing enterprises in China, of which, 200 enterprises own above designated scale. However, only about 20 enterprises have the ability to achieve annual sales income of more than CNY 100 million; most of enterprises are in small scale and the product variety is few. In 2013, the market scale of China’s IVD industry reached CNY 22.5 billion; among them, the market scale of IVD reagents was about CNY 16.3 billion.
FDA will recognize a regulatory category called “complementary diagnostics” for tests that provide additional information about how a drug might be used, but that are distinct from “companion diagnostics,” which are essential for the safe and effective use of a drug.
Theranos, Inc. (Theranos) today announced that it has received the U.S. Food and Drug Administration's (FDA) clearance of its test system and test for herpes simplex 1 virus IgG. The FDA's decision provides independent validation of Theranos' patented finger stick and venous blood testing technology and the ground breaking Theranos System upon which the HSV-1 IgG test is run, as well as the approach that the company has supported for FDA review of Laboratory Developed Tests (LDTs).
Point of Care Testing Market Overview The concept of Point of Care Testing (POCT), also known as bedside, near-patient testing and decentralized testing, relates to tests that are conducted by clinical operators at the site of patient care where immediate medical action is taken on the results. The fact that point of care (POCT) represents a departure from conventional laboratory medicine has created new opportunities in the field of diagnostics industry. Technical advancements over recent years have helped point of care testing (POCT) to grow with double digit CAGR from 2009 to 2011 and evolve into a vital diagnostic tool. It is predicted that point of care testing market will be approximately US$ 25 Billion by 2016.
Rapid advances in molecular diagnostics and cancer biology are transforming the respective oncology research and drug development organizations. Subsequently, this has led to the evolution of new testing protocols and clinical trials paradigm aimed at matching patient therapies to improve treatment outcomes and to treat them with innovative personalized cancer therapies. These efforts will heavily rely on validated biomarkers and are expected to transform the importance of clinical laboratories application in oncology diagnostics and treatment. Personalized medicine is defined as the customization of particular treatment based on a patient’s somatic genetics and is capable of transforming healthcare treatments for various disorders. Among all the molecular genetic assays, companion diagnostics are an important tool in the implementation of this personalized medicine therapy. The information that is derived from companion diagnostic tests specifies the customization of therapies based on genetics of the disease.
The world stands on the cusp of eradicating the polio virus, but a new study examining transmission of the virus suggests that the battle will continue long after the last case of the disease is reported.
A new two-pronged approach to treating antibiotic-resistant bacterial infections developed at Tel Aviv University has been shown in lab tests to kill off strains unaffected by antibiotics while making others more susceptible to the drugs. Using bacterial viruses called phages, researchers delivered edited DNA to the resistant strains, which kills them off, and eliminates the transfer of resistant genes between strains, resensitizing bacteria to antibiotics.
This course will provide students with a clear and comprehensive view of the regulatory framework surrounding in vitro diagnostic (IVD) medical devices in the US. Despite technical recognition as a subclass of pure medical devices, IVDs face different FDA expectations for pre- and post-market commercialization."? Students will acquire detailed insight into the applicable definitions, classification schemes, paths to market, pre-market submissions, CLIA categorization, quality system requirements, and post-market requirements as well as introduction to the new subclass of IVDs, companion diagnostics.
1. Passages from Frost & Sullivan's "Effect of US Healthcare Reform on the In Vitro Diagnostics Market" From Volume to Value: Healthcare Reform Reshapes Deli...
GBI Researchs report, In Vitro Diagnostics Market to 2018 – Consolidation, Decentralization and Demand for Genetic Testing to Shape the Competitive Landscape provides key data, information and analysis on the global In Vitro Diagnostics (IVD) market. The report provides market landscape, competitive landscape and market trends information on seven IVD market categories: immunochemistry, clinical chemistry, infectious immunology, hematology, microbiology culture, histology and cytology and genetic testing.
Rapid point of care identification of bacterial infections remains an elusive goal in many instances, with labs around the world relying on culturing that can take days. The other option is for path labs to employ real-time polymerase chain reaction that can be too expensive for many clinics. Now researchers at the Korea Advanced Institute of Science and Technology (KAIST) report in journal Optics Express on a new microscopy technique that can identify the strain of a bacterial pathogen from a single example of the microorganism.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for in an vitro diagnostic device for detection of Enterovirus D68 (EV- D68) strains detected in North America in 2014. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device.
It has been long known that malignant tissues release chemicals that are different from normal tissues, and dogs have the ability to sniff out some of these subtle differences in breath samples. Australian researchers at the University of Adelaide are now on the road to developing a laser system that can analyze a person's breath and screen for a variety of diseases
A team of scientists including PhD student Friedrich Schuler from the Laboratory of MEMS Applications at the Department of Microsystems Engineering (IMTEK) of the University of Freiburg has developed a method for dividing a DNA sample into thousands of tiny droplets. What sets it apart from previous methods is above all the fact that it is considerably easier to control and rapidly generates more than 10,000 droplets with a diameter of approximately 120 micrometers each. The entire process takes place on a rotating plastic disk the size of a DVD. The researchers presented the new method in an article in the journal Lab on a Chip ("Centrifugal step emulsification applied for absolute quantification of nucleic acids by digital droplet RPA ").
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has been selected to provide HIV-1 viral load and early infant diagnostic technologies for the Global Fund. This marks a further step in the collaboration between Roche and the Global Fund, an organization that has pioneered providing effective and economic solutions for healthcare to achieve the best results for patients.
As a logical consequence of impressive growth for several years running, the Microfluidic Industry is showing production-strengthening signs on both the industrial and manufacturing fronts. The Microfluidic Device market will continue to grow swiftly, from $2.56B in 2015 to $5.95B in 2020. This annual 18% growth will still be mainly driven by Pharmaceutical research and Point-of-Care applications. In this report, you will find more details about microfluidic applications.
A new bioink made from silk has successfully been printed onto hospital gloves and changes color when it comes into contact with certain kinds of bacteria. Researchers at Tufts University say that certain properties of the silk protect heat-sensitive biomolecules during the ink-jet printing process, and that the method could open the door to a host of new therapeutic, biosensor, and regenerative medicine applications.
Roche has agreed to provide HIV-1 viral load and early infant diagnostic technologies for the Global Fund. Under the collaboration, Roche will provide HIV-1 tests with dual-target design to simultaneously amplify and detect two separate regions of the HIV-1 genome that are not subject to selective drug pressure.
Antibiotic resistance is a phenomenon that's sweeping the globe, worrying scientists that a "post-antibiotic era" is in our future. Now, the World Health Organization (WHO) has revealed its plan to combat such an outcome using DNA.
Roche today announced it has entered into an agreement to develop a companion diagnostic (CDx) test for dalcetrapib, a therapeutic from DalCor Pharmaceuticals (DalCor), which will target patients with a specific genotype who have experienced a recent Acute Coronary Syndrome (ACS) event. The CDx test from Roche will be used in a phase III clinical trial that will seek to validate the clinical efficacy of dalcetrapib, an investigational medicine that according to a recently published analysis by the Montreal Heart Institute, could potentially reduce cardiovascular morbidity and mortality by as much as 39 percent in patients with a specific genetic profile.
The global market was valued at $49.2 billion in 2012 and is expected to reach $69.1 billion by 2017, at a CAGR of 7% from 2012 to 2017. This market is primarily driven by rising incidences of chronic and infectious diseases in emerging economies, a rapidly aging population, the rise in point-of-care testing, and the rising importance of personalized medicine. However, factors such as stringent regulatory frameworks and a shortage of budget and labor are restraining the growth of the market.
Genome sequencing company Illumina has announced plans to launch a new next-generation sequencing (NGS) epidemiology solution for microbiology service laboratories. In partnership with in vitro diagnostic multi-national bioMérieux, who are experienced in microbiology, Illumina will develop systems for bacterial genotyping to underpin prevention measures and rapid tracking and containment of infectious disease agents in communities and hospitals.
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