IVDT Insight

FDA Advisory Committee Issues Unanimous Recommendation for OraQuick In-Home HIV Test

OraSure Technologies Inc. yesterday announced that FDA's Blood Products Advisory Committee (BPAC) provided a unanimous positive recommendation for the company's OraQuick In-Home HIV Test. The BPAC provides advice to the FDA on issues related to the safety and effectiveness of biological products and medical devices seeking FDA approval.

The BPAC voted on two questions posed by FDA:

  • Do the projected benefits of the test outweigh the potential risks of false positive and false negative test results? The committee voted 17-0 in the affirmative to that question.
  • Do the available data provide reasonable assurance that the test is safe and effective for its intended use? The committee voted 17-0 in the affirmative to that question.

In addition to reviewing the company's clinical data and performance, the...

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May 16th, 2012
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FDA Expands Use for FilmArray Respiratory Panel

This week FDA expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.
The expanded use of the panel adds the bacteria Bordetella pertussis, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. The FilmArray Respiratory Panel is the first FDA-cleared molecular diagnostic test able to identify the three bacteria.
Bordetella pertussis is the cause of pertussis, or whooping cough, a serious disease in very young children. Mycoplasma pneumoniae is a common cause of respiratory infection and community-acquired pneumonia, sometimes resulting in large outbreaks, especially in children and young adults. Chlamydophila pneumoniae is a cause of community-acquired pneumonia that can be more serious in...

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May 16th, 2012
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Buoyant Growth Predicted for IVDs in BRICs

Looking for more than modest growth for your IVD product portfolio? Focus on the BRICs, says a new report from GlobalData. Brazil, Russia, India and China (BRIC) represent growth opportunities for the diagnostic testing industry, as population growth and unhealthy lifestyles in these emerging economies expand the patient population.

The report, titled In Vitro Diagnostics (IVD) - Emerging Countries (Brazil, Russia, India, China) Opportunity Assessment, Competitive Landscape and Market Forecasts to 2018, predicts that new technologies, a shift towards point of care (POC) testing and cost containment will drive growth over the coming years. "The ever increasing patient pool, improving healthcare...

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May 10th, 2012
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Roche 454 Life Sciences and SoftGenetics Sign Co-Promotion Agreement for Sequencing Software

454 Life Sciences, a Roche company, and SoftGenetics announced today that the two firms have entered into a copromotion agreement designed to provide users of 454 Sequencing Systems the range of next-generation sequencing data analysis options provided by SoftGenetics’ NextGENe software.

Roche describes the software as being “a free-standing, biologist-friendly software multi-package that is fully compatible with 454 Sequencing data for a wide variety of applications, including targeted amplicon resequencing, exome sequencing, transcriptome sequencing, forensic profiling, and more.”

The software package provides additional options for users of 454 sequencing systems, in addition to the GS Data Analysis Software suite provided with the platforms.
 
 “This agreement permits both 454 and SoftGenetics the opportunity to more fully understand and address the rapidly changing needs of the NGS marketplace,”...
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May 9th, 2012
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Molecular Diagnostics Is Star Performer of Global IVD Market Projected to Show Overall Modest Growth

Valued at $44 billion in 2011, the global IVD market is expected to experience modest growth through 2016, according to a report published by reportlinker.com. The United States represents approximately half of the total market for IVD equipment, notes In-Vitro Diagnostics (IVD) Market (Clinical Chemistry, Immunoassays, Molecular Diagnostics, Hematology Analyzers & Microbiology Culture) - Global Trends & Forecasts to 2016.

Various segments of the IVD market are analysed in the 394-...

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May 9th, 2012
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Novel Compound Could Potentially Disrupt Amyloid Formation in Alzheimer's Patients

UC Davis researchers have found novel compounds that disrupt the formation of amyloid, the clumps of protein in the brains of people with Alzheimer’s disease believed to be important in causing the disease’s characteristic mental decline. The so-called “spin-labeled fluorene compounds” are an important new target for researchers and physicians focused on diagnosing, treating and studying the disease.
The study, published recently in the online journal PLoS ONE, is called “The influence of spin-labeled fluorene compounds on the assembly and toxicity of the Aβ peptide.”
“We have found these small molecules to have significant beneficial effects on cultured neurons, from protecting against toxic compounds that form...

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May 9th, 2012
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New to U.S. Retail Shelves: Blood Glucose Monitor that Connects to iPhone (And an App To Match)

Sanofi's iPhone-compatible blood glucose monitor and app

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May 7th, 2012
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UCLA Prof Can Turn Your Smartphone Into a Rapid Dx Test Reader

Rapid diagnostic test reader developed at UCLA
Smartphone with RDT reader developed by researchers from the UCLA Henry Samueli School of Engineering and Applied Science and the California NanoSystems Institue at UCLA. Image: UCLA

Aydogan Ozcan, a UCLA professor of electrical engineering and bioengineering, and his colleagues from the UCLA Henry Samueli School of Engineering and Applied Science and the California NanoSystems Institute at UCLA have developed a compact and cost-effective rapid-diagnostic-test-reading device that works in tandem with "smart" mobile phones, such as iPhones. “What we have created is...
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May 4th, 2012
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EU Guidance on Stand-Alone Software Used in IVD Applications

Guidance on the classification of stand-alone software used in healthcare applications was published earlier this year by the European Commission. MEDDEV 2.1/6 – Guidelines on the Qualification and Classification of Stand-Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices provides clarification of definitions that link to Europe's medical device and IVD directives.

Specifically, the document provides guidance on determining if software qualifies as a medical device and, if so, whether it qualifies as a medical device under the general medical device directive or as an in vitro diagnostic device under the IVD directive. A decision tree contained within the report can be a huge help in making that determination.

To learn more about MEDEV 2.1/6 and more generally how the...

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May 4th, 2012
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Dako, Genentech Collaborate on Submission of Companion Diagnostics

 

Denmark-based Dako has signed an agreement with Genentech, part of the Roche Group, to collaborate on the regulatory submissions of Dako’s HercepTest and HER2 FISH pharmDx as companion diagnostics for a Genentech investigational drug candidate, trastuzumab emtansine (T-DM1), in patients with advanced HER2-positive breast cancer.
Dako and Genentech will collaborate on the regulatory FDA submissions of HercepTest and HER2 FISH pharmDx to identify cancer patients who may be eligible for treatment with the Genentech drug, according to a press release distributed by Dako.
 
The announcement comes on the...
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May 3rd, 2012
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