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Patent
Oncimmune | Date: 2016-09-23

The invention generally relates to the field of immunoassays. In particular, the invention relates to use of a calibrator material to calibrate immunoassays for autoantibodies.


Jett J.R.,National Jewish Health | Peek L.J.,Oncimmune | Fredericks L.,Oncimmune | Jewell W.,Oncimmune | And 3 more authors.
Lung Cancer | Year: 2014

Objectives: EarlyCDT®-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient. Methods: Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging. Results: Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity. = 41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II. Conclusions: EarlyCDT-Lung has been extensively tested and validated in case-control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer. © 2013 The Authors.


Patent
Oncimmune | Date: 2012-04-25

The invention generally relates to the field of diagnostic or prognostic assays and in particular relates to assays for the detection of antibodies in a sample comprising patient bodily fluid, wherein such antibodies are used as biological markers of a disease state or disease susceptibility. The assay is based on cross-titration of both the patient bodily fluid to be tested for the antibody and an antigen used to detect the antibody by specific binding.


Patent
Oncimmune | Date: 2013-09-24

The application generally relates to the field of diagnostic or prognostic assays and in particular relates to assays for the detection of antibodies in a sample comprising patient bodily fluid, wherein such antibodies are used as biological markers of a disease state or disease susceptibility. The assay is based on cross-titration of both the patient bodily fluid to be tested for the antibody and an antigen used to detect the antibody by specific binding.


Patent
Oncimmune | Date: 2011-01-19

The invention generally relats to the field of diagnostic or prognostic assays. In particular, the invention provides a method of determining an antibody profile in a test sample comprising a bodily fluid from a mammalian subject, wherein the antibody is a biological marker of a disease state or disease susceptibility.


Patent
Oncimmune | Date: 2014-04-07

The invention relates to a method of detecting a disease state or disease susceptibility in a mammalian subject which comprises detecting an antibody in a test sample comprising a bodily fluid from said mammalian subject wherein said antibody is a biological marker of a disease state or disease susceptibility, the method comprising: (a) contacting said test sample with a plurality of different amounts of an antigen specific for said antibody, (b) detecting the amount of specific binding between said antibody and said antigen, (c) plotting or calculating a curve of the amount of said specific binding versus the amount of antigen for each amount of antigen used in step (a) and (d) determining the presence or absence of said disease state or disease susceptibility based upon the amount of specific binding between said antibody and said antigen at each different antigen concentration used.


Patent
Oncimmune | Date: 2014-04-07

The invention relates to a method of detecting a disease state or disease susceptibility in a mammalian subject which comprises detecting an antibody in a test sample comprising a bodily fluid from said mammalian subject wherein said antibody is a biological marker of a disease state or disease susceptibility, the method comprising: (a) contacting said test sample with a plurality of different amounts of an antigen specific for said antibody, (b) detecting the amount of specific binding between said antibody and said antigen, (c) plotting or calculating a curve of the amount of said specific binding versus the amount of antigen for each amount of antigen used in step (a) and (d) determining the presence or absence of said disease state or disease susceptibility based upon the amount of specific binding between said antibody and said antigen at each different antigen concentration used.


Oncimmune, a leader in early cancer detection, today announced the appointment of Meinhard Schmidt as Non-Executive Chairman. Meinhard has more than 25 years international experience as an entrepreneur and senior executive in the diagnostics and medical devices industries. Between 1998 and 2008 he was at Roche Diagnostics where he held various global senior leadership roles and was global Senior VP at Lab Diagnostics, which achieved the leading global position in the laboratory industry. Meinhard has strong board level experience and has worked across M&A, global operations, sales and marketing, program and innovation management and has held executive management positions in Germany, The Netherlands, USA, Canada, Sweden, UK and Switzerland. He currently serves as Board Director at Sphere Medical PLC, valuationLAB AG, CeQur AG and as Chairman at Promimic AB. Meinhard Schmidt, said: "The early detection of cancer can transform outcomes for patients. Oncimmune's EarlyCDT® technology has an excellent scientific pedigree, has been extensively validated and EarlyCDT®-Lung is already on the market in the US, UK and other territories. With the prospect of building on the technology platform to expand into additional cancer types and reach new markets, Oncimmune is poised for growth and I'm very pleased to become Chairman at this exciting time in the Company's development." Geoffrey Hamilton-Fairley, CEO of Oncimmune Limited, said: "It is a great pleasure to welcome Meinhard as Chairman of Oncimmune. His industry experience is exceptional and I very much look forward to working with him as we accelerate the next stage in the Company's development, namely the further commercialisation of EarlyCDT®-Lung on a global basis and the launch of our new EarlyCDT® cancer tests. Meinhard's commercial expertise will enable us to realise the potential of our pioneering autoantibody approach to cancer detection." EarlyCDT-Lung is being used in the world's largest randomised trial for the early detection of lung cancer using biomarkers ever conducted; the National Health Service (NHS) Scotland ECLS study of more than 10,000 high-risk smokers. Early results showing a cancer detection rate of 81%, better than the stated test performance, were recently presented at the 16th World Conference on Lung Cancer. Oncimmune is an industry leader in early cancer detection. The company has pioneered the development of autoantibody assay technologies that have the potential to allow earlier cancer detection than other methods and be applied to a very wide range of solid tumour types. The Company's proprietary EarlyCDT® technology platform was launched in 2009 and EarlyCDT®-Lung is available through physicians in the US and also privately in the UK and other regions. EarlyCDT® tests for liver and ovarian cancer are in final validation. Oncimmune is headquartered in Nottingham, United Kingdom with testing facilities in the US.


News Article | June 2, 2010
Site: www.cnet.com

The detection and treatment of solid cancers such as lung, breast, ovarian, colon, and prostate cancers could be on the verge of a major makeover, thanks to a new blood test developed at the University of Nottingham and spinoff company Oncimmune. Early in a tumor's development, cancer cells produce antigens that trigger the body's immune system to release auto-antibodies in an attempt to fight them off. The body produces an abundance of these auto-antibodies to win the battle--more than the tumor does antigens, making the auto-antibodies easier to detect. The test measures a panel of auto-antibodies in a blood sample to determine the likelihood of a tumor being present. In clinical trials, it has helped detect cancer as many as five years earlier than current mammography and CT scans. Based on the early work of John Robertson, a renowned breast cancer specialist and University of Nottingham professor who launched Oncimmune in 2003, the company's first blood test to hit the market--called EarlyCDT-Lung--is to be released in the U.S. later this month and in the U.K. in early 2011. "We believe this test, along with the others we will launch in the next few years, will lead to a better prognosis for a significant number of cancer sufferers," says Geoffrey Hamilton-Fairley, Oncimmune's executive chairman, in a news release. The research first launched at Nottingham analyzed blood samples from patients with breast cancer and a group of high-risk women in for an annual mammography. Robertson identified not only the signal in the blood of those women who developed breast cancer, but he also found that his prototype test could have detected cancer in more than half the patients up to four years before they were eventually diagnosed. The more recent research resulting in the lung cancer test came out of a European Union grant involving the university and Oncimmune. The EarlyCDT-Lung test's target population is high-risk individuals, from long-term and ex-smokers over the age of 40 to people exposed to radon, asbestos, or extensive second-hand smoke. Oncimmune says EarlyCDT-Lung will be available in the U.S. via primary care physicians and pulmonologists, and the company will bill private insurance companies as well as government-run Medicare Part B carriers on behalf of the patient. "I am very pleased that the initial exciting research data that we produced in the laboratories at the University of Nottingham a number of years ago have been translated by Oncimmune to the first of many tests that will help us identify cancer early," Robertson said. "It has been a long and at times very hard road in creating a robust commercial test."

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