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LabCorp Announces the Launch of the Epi proColon Test for Colorectal Cancer Screening

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced the launch of Epi proColon®, a blood-based test for colorectal cancer screening that was approved on April 13, 2016 for clinical use by the U.S. Food and Drug Administration (FDA). Epi proColon® is the first FDA-approved DNA based blood test for colorectal cancer. The test was developed by Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) and is available under a joint commercialization agreement with Polymedco, Inc. in North America. LabCorp, the world’s leading healthcare diagnostics company, is the first laboratory in the U.S. to offer this FDA-approved, blood-based colorectal cancer screening test.

Cancer Research UK and CRT Collaborate with Abcodia to Discover and Develop Tests for Early Diagnosis of Cancer

Cancer Research UK and its commercial arm, Cancer Research Technology (CRT), have joined forces with Abcodia, the biomarker validation company with a focus on cancer screening, to develop new blood tests to detect a range of cancers when they are still at a very early stage.

The strategic alliance will focus on biomarkers to detect cancers before patients develop symptoms, concentrating on cancers which currently have limited screening tests available, such as non-small cell lung cancer.

Detecting cancer earlier will give doctors the best chance to treat cancer effectively, before the disease develops and spreads when it becomes more difficult to treat. Identifying patients at an early stage will also provide the scientific and pharmaceutical communities with the ability to select patients for the development of a new generation of anti-cancer medicines.

The partnership combines Cancer Research UK’s extensive clinical oncology and scientific network with Abcodia’s expertise in the longitudinal profiling of biomarkers, as well as its exclusive access to one of the world’s largest prospective collections of serum samples available for biomarker research. This collection is derived from the UK Collaborative trial for Ovarian Cancer Screening* (UKCTOCS) run at University College London (UCL) and contains more than five million serum samples. The trial is part funded by Cancer Research UK.

The samples in the collection have been taken from healthy people annually and in many cases, up to 10 years prior to a cancer diagnosis. The collaboration will use these samples to select biomarkers which provide a clear indication of change in the early pre-diagnosis stages of disease.

Cancer Research UK, CRT and Abcodia will seek partnerships in the UK and internationally, with academic and commercial organisations which have leading-edge biomarker technology, to discover, validate and further develop the markers.

Dr Julie Barnes, Abcodia’s CEO, said: “We are delighted to be able to work with Cancer Research UK and CRT in this new global venture. The early diagnosis of cancer has never been more important and with the collective expertise that this alliance can bring, we hope to make a real difference in the field of early cancer detection and screening.”

The alliance is particularly interested in seeking markers that may be expressed in serum; for example, proteins, microRNAs – regulators of gene expression, exosomes ¬– cell-derived vesicles, autoantibodies – antibodies targeting an individual’s own proteins, and DNA methylation – a molecular switch to turn DNA on and off. Both genetic and acquired risk factors will also be investigated.

Abcodia and CRT will jointly commercialise any biomarkers discovered during the collaboration and share revenues resulting from potential licensing deals with additional third parties.

Dr Harpal Kumar, Cancer Research UK’s chief executive, said: “Earlier detection of cancer remains a huge challenge but also a tremendous opportunity. We know that for most types of cancer, the earlier we detect them, the greater the chance of being able to treat them effectively and successfully. Furthermore, treating earlier stage disease is usually associated with fewer side effects from treatment for our patients. The scope and scale of this alliance, aimed at developing new tests for a range of cancers at their earliest stage, before symptoms develop, is very exciting. The combination of expertise formed by this partnership provides a great opportunity to accelerate this vital biomarker research, which we hope will help save thousands of lives from cancer.”

Professor Ian Jacobs, Vice President at the University of Manchester, Principle Investigator of UKCTOCS and an Abcodia founder, said: “I’m delighted that the biobank developed through UKCTOCS will be used for such an important collaborative venture which has potential to yield important discoveries and to benefit patients through early detection across a range of cancers.”

Dr Keith Blundy, Cancer Research Technology’s chief executive, said: “This important alliance combines Cancer Research UK’s clinical expertise, with the commercialisation expertise of both Abcodia and CRT. Together with additional technology partners, we hope to be able to identify early detection biomarkers that will enable patients to be treated as soon as possible, ultimately saving lives.”

Source: Abcodia

PrimeraDx to Co-Develop Companion Diagnostics with Quest Diagnostics

PrimeraDx, Inc., a molecular diagnostics company, recently announced it has formed a non-exclusive diagnostics co-development agreement with Quest Diagnostics (NYSE: DGX), the world’s leading diagnostics information services company. The intent of the collaboration is to co-develop and commercialize molecular diagnostic products and services with a focus on supporting clinical development of targeted therapeutics for drug developers.

Scientists Decode ‘Software’ Instructions of Aggressive Leukemia Cells

A team of national and international researchers, led by Weill Cornell Medical College scientists, have decoded the key “software” instructions that drive three of the most virulent forms of acute lymphoblastic leukemia (ALL). They discovered ALL’s “software” is encoded with epigenetic marks, chemical modifications of DNA and surrounding proteins, allowing the research team to identify new potential biomarkers and therapeutic targets.

Epigenomics AG Announces Non-exclusive Licensing Agreement for Septin9 with Companion Dx Reference Lab

Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, announced today that it signed a non-exclusive licensing agreement for its proprietary DNA methylation biomarker Septin9 with Companion Dx Reference Lab (“Companion Dx”), an emerging leader in pharmacogenomic testing and cancer companion diagnostics. Under the terms of the agreement, Companion Dx has obtained rights to establish and commercialize a blood-based, laboratory-developed test (LDT) using methylated Septin9 as biomarker for the detection of colorectal cancer. Epigenomics is entitled to double digit royalties on sales.

“The addition of Septin9 to our offering of cancer related products will allow us to more effectively serve the Texas cancer testing market. Colorectal cancer is the second leading cause of cancer-related deaths in the U.S., and we believe that the blood based method to detect colorectal cancer in the currently non-compliant patient population will improve participation in screening and therefore save more lives in Texas”, said Steve Blum, CEO of Companion Dx.

“Based on the growing uptake of the Septin9 assay through our LDT licensees, we are excited to add regionally focused Companion Dx lab to the list of our partners as we recognize their ability to reach incremental sub-populations who should be but are not currently screened according to guidelines”, said Noel Doheny, Chief Executive Officer of Epigenomics’ US subsidiary. “Companion Dx shares our objective of providing tests that will help physicians to improve the health outcomes for patients through accurate detection of colorectal cancer and to potentially decrease the rising costs associated with colorectal cancer in the U.S. With today’s licensing agreement, we continue to execute on our commercialization strategy, well ahead of the launch of a proprietary diagnostic product approved by the FDA”, explained Mr. Doheny.

The agreement with Companion Dx complements Epigenomics’ LDT agreements with Quest Diagnostics, ARUP Laboratories and Warnex Medical Laboratories in North America. Furthermore, Abbott Molecular has worldwide, non-exclusive license to develop and to commercialize IVD test kit products while Qiagen and Sysmex have acquired options to do so.

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