IVDT Insight

FDA Approves Roche's HbA1c Test for Diagnosing Diabetes

A milestone was reached for diabetes diagnosis today: FDA announced that it is allowing marketing of Roche's Cobas Integra 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for diagnosing diabetes. This is the first HbA1c test that FDA has allowed to be marketed for this use.
The HbA1c tests currently on the market are FDA-cleared for monitoring a patient’s blood glucose control, but not for diagnosing diabetes. HbA1c tests measure the percentage of hemoglobin A1c that is bound to glucose, giving a patient’s average glucose level over a three-month period. 
An estimated 25.8 million people in the United States have diabetes, including seven million people who remain undiagnosed.
The diagnostic criteria for diabetes have changed over time. Based on the research and recommendations of international diabetes...

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May 23rd, 2013
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Corgenix and Eli Lilly Join Forces to Develop Oncology Dx

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.

While the financial terms of the partnership were not disclosed, Corgenix will help further the development of diagnostic technology that was first developed by Eli Lilly. This latest agreement is part of Corgenix’s new initiative to expand its Contract Services Business Unit (CSBU). CSBU provides biotechnology and healthcare contract services for manufacturing, technology application, and product development.

Corgenix manufactures a wide variety of diagnostics for joint disorders, bone disorders, vascular diseases and immunology disorders. As of now, the company has...

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May 23rd, 2013
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UC Irvine Researchers Develop Urine Prostate Cancer Dx

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.

Men with prostate cancer usually have elevated levels of PSMA proteins in their urine. The new diagnostic uses a plastic film that is filled with a PSMA-sensitive virus. The test provides more than just a positive or negative indication for PSMA; it can also determine the level of PSMA in a patient’s urine.

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...

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May 23rd, 2013
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New Medicare Test Reimbursement Bill Introduced; Replaces Dead H.R. 6446 Bill

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%...

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May 23rd, 2013
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EKF Molecular To Launch Cancer Gene Detection Technologies at ASCO 2013

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....

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May 22nd, 2013
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Researchers at John Hopkins Develop Postpartum Depression Diagnostic

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...
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May 22nd, 2013
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Quest Diagnostics Buys Clinical and Toxicology Labs from Humana

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...
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May 20th, 2013
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The Chemical Angel Network: A New Breed of Angel Network

 

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...
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May 20th, 2013
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Australian Regulators Propose Changes for IVDs

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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May 17th, 2013
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Angelina Jolie's Announcement Keeps Myriad Genetics in Spotlight
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...

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May 15th, 2013
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