Health regulators in Australia have made a proposal incorporating new changes in the upcoming in vitro diagnostic regulations. Changes are proposed for public comment before a planned implementation in July of 2014. The new IVD scheme comes with several significant changes in high-level components.
A new classification system will break IVDs down into four different classes based on their properties. To comply with regulations, all IVDs sold commercially must be registered in the Australian Register of Therapeutic Goods.
IVDs must be designed to certain standards of performance, safety, and quality. To ensure these quality standards are met, IVD manufacturers are required to apply conformity assessments as part of a regulatory and quality assessment inspection process.
The Australian Therapeutic Goods Administration made a proposal for a graduated change to help give impacted companies more...
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| Angelina Jolie |
American actor and celebrity Angelina Jolie announced this week via an op-ed in The New York Times that she had undergone a radical double-mastectomy after testing positive for BRCA1 gene mutation.
The test that provided Jolie's results was Myriad Genetics' BRACAnalysis, a laboratory-developed test (LDT) that screens for BRCA1 and BRCA2 mutations. These mutations are, as anyone following the popular media this week now knows, associated with...
Roche (Indianapolis, IN) received FDA approval for a lung cancer companion diagnostic and its associated therapy, Tarceva. The Cobas EGFR Mutation Test looks for the presence of a specific mutation that is implicated in the development of non-small-cell lung cancer.
The EGFR mutation test is used to check for the presence of epidermal growth factor receptors in a patient’s genome. Depending on test results, physicians will be able to prescribe Tarceva, a tablet cancer treatment that is reportedly very effective in patients who test positive for EGFR mutations. The drug is marketed by Roche's Genentech and Astellas Pharma.
One factor that helped the company earn FDA approval was its EURTAC study. The EURTAC study helped the company validate expanded approval for Tarceva.
For Roche, the market for lung cancer...
A new collaboration between a Japanese company and a startup in the United Kingdom could lead to the development of a new early-stage lung cancer diagnostic. Cizzle Biotechnology has licensed its technology and patents for a lung cancer diagnostic to Fujirebio Diagnostics. Under the terms of the loan, both companies will work together to develop the new test.
U.K.-based Cizzle Biotechnology was spun out from York University. Fujirebio Diagnostics (Malvern, PA) is a division of Japan-based Fujirebio and maintains headquarters in Sweden and Texas.
Researchers at York University identified a mutation in a certain protein, dubbed CIZ1, that is associated with an increased risk of lung cancer. One advantage of this protein is that it can forecast an individual’s personal risk. Higher levels of this protein are often...
A new blood diagnostic by researchers at Michigan State University could help spot dangerous forms of malaria in children. Researchers detailed their findings in the Journal of Infectious Diseases. The research project was done as a joint collaboration with the University of Malawi.
The mosquito-transmitted malaria parasite produces a unique protein known as HRP2. The new diagnostic developed by researchers looks for levels of HRP2 in a patient’s blood. Results from the study show that there is a positive correlation between the presence of HRP2 and the risk of cerebral malaria. Children with low levels of this protein carried a low risk of developing cerebral malaria. On the other hand, patients with high HRP2 levels often developed a more dangerous form of the disease as time passed. With personalized...
Abbott today announced CE marking for the ARCHITECT clinical chemistry hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes.
The HbA1c test is a blood test that reflects a person’s average blood glucose levels over the past three months. In 2009, an international expert committee recommended that physicians may use an HbA1c test for the diagnosis of type 2 diabetes and identification of patients at risk for developing diabetes if the assay meets specific performance criteria, such as certification and standardization processes outlined by the National Glycohemoglobin Standardization Program and the International Federation of Clinical Chemistry.
For people whose HbA1c test results are normal, doctors may recommend that testing be repeated at least every three years or more frequently depending on a person’s initial results and risk status.
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Aviir Inc., a biotechnology company focused on the prevention of cardiovascular disease (CVD) through innovative laboratory tests, announced that it will be extending its offered services with a comprehensive inherited cardiovascular disease genetic test menu.
The newly validated tests cover the major causes of cardiomyopathies, arrhythmia disorders, and other genetically transmitted diseases that affect the heart and vasculature. Each test is available for both individuals and family groups. Two comprehensive panels are available to check for undiagnosed arrhythmia or cardiomyopathy.
Doug Harrington, MD, CEO of Aviir, said in a prepared statement, "The novel approach Aviir has taken to identify disease-causing genetic variants allows for not only an unprecedented level of thoroughness---100% coverage of the disease-causing genes--- but also for unmatched speed in returning results to physicians and...
Sequenom (San Diego, CA) released a positive first quarter earnings report, buoyed by solid sales of its MaterniT21 Plus test. With a 158% increase in first quarter revenue, the company has established itself as a solid player in the prenatal testing business.
While revenues at the company were positive, these increases did come at a significant price. Costs at the company doubled from the first quarter of 2012. While revenue was $38.5 million, the company experienced a net loss of $29.4 million. In comparison, the first quarter of 2012 yielded a net loss of $24.4 million.
Several different factors contributed to this wider...
Good Start Genetics (Cambridge, MA) landed $28 million in financing. Funds will be used to expand development of the company’s genetic screening tool, dubbed GoodStart Select. GoodStart Select can detect 23 different genetic diseases, including sickle cell disease and cystic fibrosis.
GoodStart Select targets the in vitro fertilization market. Because of this, the company has been concentrating its marketing efforts on 460 in vitro fertilization centers across the United States.
Unlike other carrier tests, the GoodStart Select screening system uses gene sequencing to get more accurate results. One weakness of non-sequencing tests is that they can miss rare...
Mindray Medical (Shenzhen, China) released a very positive first quarter earnings report. The company’s diagnostics segment yielded strong results with a 10.5% increase in revenue over Q1 of 2012.
Net income at the company jumped 57% to $57.4 million. For the most part, the company’s success in the first quarter stems from domestic sales. While international sales grew 2.8 percent, domestic sales increased 21.2 percent. The company blamed these lower international sales on pricing pressures from overseas markets.
For the 2013 fiscal...
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