A new blood diagnostic by researchers at John Hopkins University could help physicians predict postpartum depression in women. The new test screens an individual’s genome for two mutated genes associated with an increased risk of postpartum depression. Details of the latest findings were published in the journal Molecular Psychiatry.
Quest Diagnostics (Madison, NJ) acquired the clinical laboratory and toxicology segment of Humana, a health insurance giant. As of now, neither company is revealing the financial terms of the deal. However, Quest Diagnostics will gain access to Concerta’s Advanced Toxicology Network. Concerta is a subsidiary of Humana.
|Mark Vreeke, cofounder, Chemical Angel Network|
Health regulators in Australia have made a proposal incorporating changes regarding implementation and timeframes for IVD regulation. Changes are proposed for public comment before a planned implementation in July of 2014. The IVD scheme, updated in 2010, came with several significant changes in high-level components.
A new classification system breaks 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...
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.