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Diagnostic Tests Biotechnology

Knobbe Martens

Researchers Develop Blood Clot Test Based on Single Drop of Blood

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The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a smartphone....more

McDonnell Boehnen Hulbert & Berghoff LLP

Schadenfreude Is Not Always An Unpleasant Feeling

The Association for Molecular Pathology released a survey last week regarding the state of reimbursement for medical diagnostic testing, according to GenomeWeb. It seems that the state is parlous, with reimbursement for...more

Womble Bond Dickinson

The Analysis of Cell Free DNA in Urine for Cancer Diagnosis – A Prospective Alternative to Liquid Biopsy?

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A promising new technology may make the diagnosis of cancer and genetic mutation testing as easy as performing a urinalysis as part of an annual physical exam.  Cancer could be detected at its earliest stages, when treatment...more

Womble Bond Dickinson

Getting Closer to a Definitive Biomarker for Parkinson’s Disease

Womble Bond Dickinson on

Parkinson’s disease is a devastating, incurable, progressive and degenerative neurological disease that affects movement. There are no biomarkers available and it is diagnosed by symptomology alone. Unfortunately, the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Appendiceal Cancer Shows Age-related Somatic Gene Variants with Potential Diagnostic Relevance

Cancer of the appendix is a very rare form of cancer, having an incidence of 0.12 per 1,000,000 person-years (Siegel et al., 2020, Cancer statistics 2020 70:7-30).  Incidence is rising (by 232% from 2000-2016 in the U.S.)...more

Womble Bond Dickinson

Can a Breath Test Diagnose Head and Neck Cancer?

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Clinical manifestations of head and neck cancers often occur only after the disease has reached an advanced stage. Development of new technology for earlier diagnosis is of critical importance. Since the nasopharynx, base of...more

Bradley Arant Boult Cummings LLP

Patenting COVID-19 Tests: Avoiding the Common Pitfalls

The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so...more

Sheppard Mullin Richter & Hampton LLP

IP Protection and the Open COVID Cure Chase

As the world grapples with its response to COVID-19, the availability and nature of intellectual property protection afforded for diagnostic tests, treatments, vaccines, and accompanying data is likely to have a significant...more

Knobbe Martens

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

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Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Foley & Lardner LLP

Precision Medicine - Even Medicare Will Pay for It!

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President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more

Dorsey & Whitney LLP

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

Dorsey & Whitney LLP on

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

Foley & Lardner LLP

California Court Holds Diagnostic Claims Not Patent-Eligible

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In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more

Foley Hoag LLP

2013-2014: Evolving Challenges for Value-Priced LDTs

Foley Hoag LLP on

Introduction - In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the...more

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