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Candidate Biomarkers for Postmenopausal Osteoporosis

An article published in Experimental Biology and Medicine (Volume 242, Issue 2, January, 2017) reports a new method for identifying women at risk for osteoporotic fractures. The study, led by Dr. Katre Maasalu, Associate Professor and orthopedic surgeon from Traumatology and Orthopeadic Clinic of Tartu University, demonstrated that a biomarker panel consisting of six genes could distinguish postmenopausal women with osteoporosis, a major risk factor for fracture, from those without osteoporosis.

New Study Shows Circulating Tumor Cell Enumeration – as Part of Composite Biomarker Panel – May Serve as a Surrogate for Efficacy Response in Metastatic Castration-Resistant Prostate Cancer

Janssen Diagnostics, LLC recently announced results from a study presented at the European Cancer Congress in Amsterdam, Netherlands, that demonstrated circulating tumor cell (CTC) enumeration using CELLSEARCH®, along with lactate dehydrogenase (LDH) as part of a composite biomarker panel, was an efficacy-response surrogate for survival in managing patients with metastatic castration-resistant prostate cancer (mCRPC). The results show mCRPC patients with greater than or equal to five CTCs and an abnormal LDH level at 12 weeks of treatment have a poorer prognosis than those with lower CTC counts and normal LDH values, with a one- and two-year survival probability of 25 percent and 2 percent compared to 82 percent and 46 percent, respectively. Findings suggest therapeutic alternatives should be considered for patients in the high-risk category at 12 weeks.

OGT Marks World Lupus Day with Announcement of Novel Biomarker Panel

Oxford Gene Technology (OGT), provider of innovative genetics research and biomarker solutions to advance molecular medicine, has today announced the development of a novel autoantibody biomarker panel for improved diagnosis of systemic lupus erythematosus (SLE).

The panel has been developed in partnership with King’s College London, utilising OGT’s proprietary protein array platform technology. The platform detects autoantibodies, a class of proteins that have been shown to precede clinical symptoms of SLE by several years. It also accurately distinguishes between SLE and ‘confounding diseases’ such as rheumatoid arthritis (RA).

The biomarker panel, which was originally identified using a North American sample cohort, has been rigorously validated in two independent sample cohorts comprising over 450 European, Afro-Caribbean, and confounding disease samples. The panel maintains a high sensitivity and specificity across all cohorts studied.

SLE affects at least five million people worldwide, over 90% of whom are women. The figure may be higher as SLE is notoriously challenging to diagnose with widely variable symptoms which are inconsistent in patients. Current diagnosis is usually performed by comparing a patient’s symptoms against 11 pre-set criteria established by the American College of Rheumatology. If the patient presents any four of the symptoms simultaneously or serially on two separate occasions, they are classified as having SLE. Typically it takes several years and the involvement of many clinicians to diagnose an SLE patient.

Existing laboratory tests include antinuclear antibody (ANA) testing and anti-double stranded DNA (anti-dsDNA) testing but their specificity or sensitivity is too low to support the diagnosis or classification of SLE without additional data. The OGT panel would allow for earlier and more accurate diagnosis than existing tests addressing a clear unmet medical need.

Dr Mike Evans, CEO at OGT said, “SLE is a truly debilitating disease that is particularly challenging to diagnose. Our novel diagnostic biomarker panel is more sensitive and specific than existing laboratory tests and it is our hope that, by correctly identifying the presence of SLE at an earlier stage, patients will receive faster access to the most appropriate treatment. We are pleased with the progress of our biomarker portfolio, which also includes advanced programmes in prostate and colorectal cancer, and we are currently evaluating potential partners to develop diagnostic tests based on the SLE biomarkers.”

Professor Tim Vyse, Division of Genetics and Molecular Medicine at King’s College London said: “The OGT SLE panel represents a big step forward in lupus genetic testing and the outcome of the programme so far has been very encouraging.”

OGT is also in discussions with SLE drug developers regarding potential prognostic applications of the biomarker set to predict the occurrence and frequency of relapse, or ‘flares’, so that treatment regimens can be adjusted accordingly and patient well-being maximised.

OGT and King’s will present the results of the programme at the European League Against Rheumatism (EULAR) Meeting from 12-15 June 2013 (www.eular.org).

Source: Oxford Gene Technology

OGT Granted Prostate Cancer Biomarker Licence by the ICR

Oxford Gene Technology (OGT), provider of innovative genetics research and biomarker solutions to advance molecular medicine, recently announced that it has been granted a licence by The Institute of Cancer Research (ICR), London, to further develop and commercialise a new panel of diagnostic and prognostic microRNA biomarkers for prostate cancer. The agreement follows a three-year collaboration between OGT and the ICR resulting in the joint discovery of the microRNA biomarkers. These markers have wide-ranging potential applications in diagnosis, prognosis, treatment planning and patient monitoring.

Currently, the biomarker prostate-specific antigen (PSA) and a digital rectal examination are used to test for prostate cancer and to determine whether a biopsy is required. However, increasing evidence1 indicates that PSA may not be an effective screening tool for prostate cancer due to a high false positive rate and an inability to distinguish between more aggressive and indolent cancers.

Unlike the present screening techniques, the biomarkers discovered by OGT and the ICR have a specificity of over 90% plus the potential to not only identify prostate cancer but also to assess its aggressiveness. This is important as it will allow treatment to be tailored to specific features of the cancer. At present, a diagnosis of prostate cancer can mean removal of the prostate and chemotherapy; patients with indolent cancer often receive, but do not require, such excessive treatment.

Dr Mike Evans, CEO at OGT, said: “We look forward to continuing our work with the ICR and developing this biomarker panel further. We are hopeful that these biomarkers will change the way that patients with prostate cancer are treated. OGT has a rapidly expanding portfolio of biomarkers for early disease detection which includes highly prevalent cancers of major clinical significance, including colorectal cancer.”

Colin Cooper, Professor of cancer genetics at the University of East Anglia, who led the study at the ICR, said: “OGT and the ICR have made significant progress. Prostate cancer is the most common type of cancer in men with over 240,000 new cases diagnosed each year in the US alone; we need to focus our efforts not only on ensuring accurate diagnosis but also individualised treatment tailored by prognosis.”

In addition to further validation of the biomarker panel in tissue samples, OGT is evaluating the panel in both blood and urine samples, with initial translation of the assay to blood-based PCR testing showing very encouraging results. OGT is currently reviewing potential options for future commercialisation, including making the resulting test available through OGT’s service laboratories.

Source: Oxford Gene Technology

UCLA Dentistry Receives Major Grant to Develop Saliva Test to Predict Onset of PTSD

Each year, more than a million Americans are at-risk of developing serious mental health problems after experiencing a terrifying event or serious physical injury. Once manifested, these psychiatric illnesses, such as post-traumatic stress disorder and depression, can be extremely crippling and difficult to treat and are a leading cause of disability in civilian, military and minority populations.

Recognizing these emerging disorders early on provides health care professionals the best opportunity for preventive interventions. Now, a team of researchers, led by Dr. Vivek Shetty, a professor at the UCLA School of Dentistry, has received a $3.8 million research grant to develop a salivary-biomarker approach for identifying individuals at future risk of developing post-traumatic stress disorder and depression following a traumatic event.