IVDT Insight

EKF Diagnostics (Cardiff, UK) has announced it will launch its Molecular Diagnostics division's PointMan DNA Enrichment kits at the end of this month at the ASCO 2013 annual meeting in Chicago. The global launch will comprise three kits for enriching mutations in BRAF, KRAS, and EGFR T790M genes associated with skin melanoma and colorectal and lung cancers. PointMan kits offer highly specific and ultra-sensitive enrichment of mutant genes in a background of wild-type (normal) genes that is unmatched by existing technologies, EKF says. 
The launch of the new PointMan kits on Stand 19117 is the first new product introduction since EKF’s acquisition of 360 Genomics Limited and the establishment of EKF Molecular Diagnostics in March 2013....

May 22nd, 2013
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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.

Postpartum depression can be a debilitating mental illness that impacts women for up to 12 months after childbirth. Women often experience symptoms like anxiety, exhaustion, and sadness within four weeks of giving birth.
In a study comprising mice and 52 women, researchers determined that HP1BP3 and TTC9B genes are correlated with an 85% risk of developing postpartum depression. Researchers believe that changes in hormones associated with pregnancy are the cause of postpartum depression. In...
May 22nd, 2013
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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.

Quest Diagnostics will incorporate the insurance company’s labs into its network by the end of 2014. Quest expects the newly-acquired business to become profitable by 2014. This marks the third acquisition by Quest Diagnostics in 2013. In April of this year, the company acquired lab-related clinical...
May 20th, 2013
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Post by guest-blogger Mark Vreeke, PhD, cofounder of the Chemical Angel Network, which partners chemistry-related entrepreneurs with interested investors. Vreeke is also on IVD Technology's editorial board.

Angel investing provides much of the seed and early stage capital for new technology
Mark Vreeke, PhD
Mark Vreeke, cofounder, Chemical Angel Network
companies. An angel investment is typically seen as the capital round that bridges the funding gap between a friends-and-family round and a traditional venture-capital-backed funding round. The role of angel investing has exploded over the past two decades. Both the...
May 20th, 2013
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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...

May 17th, 2013
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Angelina Jolie's announcement helping keep Myriad Genetics in spotlight
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...

May 15th, 2013
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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...

May 15th, 2013
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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...

May 14th, 2013
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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...

May 14th, 2013
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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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May 10th, 2013
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