Corgenix (Denver, CO) and Eli Lilly (Indianapolis) announced a new partnership for the development of diagnostic technologies. Diagnostics developed through the partnership would be used for the oncology pipeline program at Eli Lilly.
Corgenix manufactures a wide variety of diagnostics for joint disorders, bone disorders, vascular diseases and immunology disorders. As of now, the company has...
In the future, getting tested for prostate cancer could be as simple as a trip to the restroom. Researchers at UC Irvine have developed a new diagnostic that uses urine for prostate cancer screening. Most traditional prostate cancer screening techniques use a patient’s blood.
Traditional blood-based prostate cancer diagnostics have several limitations. Blood diagnostics are used to check for the presence of PSA, a similar protein that is also correlated with prostate cancer. However, PSA blood tests...
The bill H.R. 6446, "Improving Diagnostic Innovations Act of 2012," introduced in September of last year, was reintroduced as H.R. 2085, “To create incentive for innovative diagnostics by improving the process for determining Medicare payment rates for new tests,” on May 22, 2013.
The original bill, H.R. 6446, introduced by Rep. Peter Roskam (R-IL), garnered 17 cosponsors but had essentially “died” after being referred to the House Energy and Commerce committee and the House Ways and Means committee.
The new version of this bill, H.R. 2085, is also sponsored by Rep. Roskam and currently has six cosponsors, four Republican and two Democrat. It was referred to the same two committees as its predecessor and has a paltry 3%...
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 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...
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...