IVDT Insight

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, and the Translational Genomics Research Institute (TGen) today announced a collaborative research agreement to discover and develop diagnostic markers for treating cancer. The two Arizona-based institutions plan to "leverage each other's expertise in discovery and diagnostic product development," according to a Ventana press release, with the goal of bringing innovative cancer diagnostic tests to patients.

The first project under the umbrella research agreement will focus on diagnostic, prognostic, and drug biomarkers for pancreatic cancer, the fourth leading cause of death from cancer in the United States. Fewer than 1 in 4 pancreatic cancer patients survive more than a year, and fewer than 6 percent survive more than five years — the worst survival rate of any cancer.
This dismal picture of pancreatic cancer is mainly due to the lack of tools for early detection...
June 26th, 2013
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Carbon nanotubes could be the future of in-vitro diagnostics, according to researchers at the New Jersey Institute of Technology. Researchers there developed a lab-on-a-chip prototype that would allow physicians to detect a virus or disease with a single drop of blood. Further information on the prototype will be released in July.

According to researchers, the device works by measuring the electrical properties of cells. Since the electrical patterns and properties of cells vary based on cell type, it’s possible to detect different types of cells through the use of this technology.
In total, researchers evaluated three cell types using three electrical probes. While researchers noted that it was still too early to build a “signature” of different cells, there...
June 26th, 2013
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Abbott (Abbott Park, IL) landed FDA approval for its hepatitis C diagnostic. The company’s new test can accurately detect seven different genotypes of the hepatitis virus through a patient’s blood sample. With the new system, physicians can provide personalized treatment for the reported 3.2 million Americans who have this infectious disease.

According to data from the Centers for Disease Control, baby boomers are 500% more likely to carry the hepatitis C virus compared the general population. Because of this, CDC officials recommend that everyone born from 1945 to 1965 get tested for hepatitis. The Abbott diagnostic is designed as a follow-up test for those who have received a positive HCV diagnosis. By accurately determining the genotype of a patient’s...
June 24th, 2013
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James Donnelly, chief scientific officer at Siemens Healthcare, delivered a keynote address at the MD&M East conference in Philadelphia last week in which he highlighted five key trends in diagnostics. Pamela L. Moore, senior vice president, content and strategy, at UBM Connect attended and summarised his speech on the Medtech Pulse blog.

Donnelly cited bifurcation of testing as one of the trends reshaping the industry. Traditional labs are getting bigger at the same time as point-of-care is experiencing rapid growth, reports Moore.

The other trends to watch are the rise of robotics, demand for faster test results, the increasing use of biomarkers, and, not surprisingly, pervasive...

June 22nd, 2013
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Atossa Genetics (Seattle, WA) is in the process of expanding the distribution network for its ForeCYTE breast health diagnostic. As of now, the company has landed a new agreement with Thermo Fisher Scientific. Under the terms of the new agreement, Thermo will distribute the ForeCYTE MASCT testing device through its Fisher segment. Atossa will process test results for the ForeCYTE diagnostic in its Seattle-based laboratory.
The breast health diagnostic is designed to collect samples of a patient's nipple aspirate fluid. Once collected, the samples undergo a specialized cytological analysis. This analysis can help detect precancerous or cancerous conditions that may be missed through traditional mammographies.
Since the sample can be taken through a 10-minute procedure in a physician’s office. Atossa believes that the diagnostic can help improve screening compliance rates for patients. Atossa relates its technology to the value provided by the Pap smear, a...

June 20th, 2013
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Exact Sciences (Madison, WI) is hoping to pull in $63.7 million in a common stock sale. Funds from the stock sale will be used to pursue FDA approval of the company’s stool-based cancer diagnostic. In addition, some of the funds will be used to scale up its distribution and commercialization network.

As of now, the company will offer 5.5 million shares at $12.35 each. Underwriters have an over-allotment option that’s good for up to 825,000 more shares. Exact Sciences believes that it will be able to close the offering by this Friday, June 21.
Earlier this month, Exact Sciences submitted final PMA data to FDA regulators for its Cologuard diagnostic, a test for screening...
June 19th, 2013
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The independent nonprofit organization DxInsights, in collaboration with AdvaMedDx, has launched the first of a series of short, educational reports on innovative diagnostic technologies. This first report, “Essential of Diagnostics: Introduction to Molecular Diagnostics,” is now available free of charge.
"This report is the result of collaboration between AdvaMedDx and DxInsights, bringing together two organizations with a shared mission of educating a wide range of stakeholders on the value of diagnostics,” said Andrew Fish, executive director of AdvaMedDx. “This report explains clearly the basic science and technology underlying molecular diagnostics and illustrates how innovation in this field is rapidly transforming patient care. This is critical information for policy makers, patients...

June 19th, 2013
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Siemens Healthcare Diagnostics has entered into a collaboration with Janssen Pharmaceutica NV to design, develop, and commercialize a companion diagnostic test associated with an early-stage drug being developed by Janssen. The drug targets autoantibodies directed against the human β1-adrenergic receptor (β1-AR) that may contribute to the development of heart failure.
The agreement states that Siemens will work with Janssen to design immunoassay-based companion diagnostic tests for use in Janssen's clinical studies. The Siemens Clinical Laboratory (SCL), a "high-complexity testing laboratory designed to advance personalized medicine" according to Siemens, will develop the clinical trial assay that will be used in Janssen’s clinical trials. In parallel, Siemens will develop and validate an in vitro diagnostic test as a companion diagnostic for the Janssen therapeutic product. The companion diagnostic test will be broadly commercialized on...

June 17th, 2013
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President and CEO of the Biotechnology Industry Organization (BIO) Jim Greenwood last week issued a statement on  the U.S. Supreme Court's decision regarding Myriad Genetics' patent claims on isolated DNA molecules.
On one hand, BIO expressed relief that cDNA remains eligible for patenting. "cDNA is the commercially most important form of DNA used in biotechnology," Greenwood wrote. "Today's decision offers urgently needed certainty for research-driven companies that rely on cDNA patents for investment in innovation."
On the other hand, BIO expressed disappointment that DNA molecules mimicking naturally occurring sequences are no longer patentable, calling that decision "a troubling departure from decades of judicial and Patent and Trademark...

June 17th, 2013
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A bill introduced to Congress in May of this year, H.R. 2085, now has a snappy, attention-getting name as well as some additional co-sponsors. "Diagnostic Innovation Testing and Knowledge Advancement Act of 2013," which replaces last year's dead-in-the-water H.R. 6446, "Improving Diagnostic Innovations Act of 2012," was brought by Rep. Peter Roskam (R-IL) and is currently co-sponsored by the following members of Congress:

  • Brett Guthrie (R-KY)
  • Ron Kind (D-WI)
  • Leonard Lance (R-NJ)
  • Richard Neal (D-MA)
  • Erik Paulsen (R-MN)
  • Patrick Tiberi (R-OH)
  • Larry Bucshon (R-IN; joined Jun 13, 2013)
  • Aaron Schock (R-IL)

Not surprisingly, the bill's sponsors are largely from medtech- and life-sciences-heavy states, among...

June 17th, 2013
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