Cardiff, UK – 29th January 2015 – EKF Molecular Diagnostics has agreed a collaboration with specialist medtech company ANGLE plc, to investigate the combination of ANGLE’s Parsortix circulating tumour cell (CTC) harvesting platform with EKF Molecular’s PointMan™ DNA enrichment technology as a liquid biopsy. If successful, the resulting simple blood test could enable the investigation of unexpected ultra-low level mutations in a patient’s cancer for personalised cancer care.
The collaboration will initially work on colorectal cancer and then expand to cover other cancer types. CTCs will be harvested from cancer patients’ blood using ANGLE’s Parsortix system and then analysed using PointMan™ DNA enrichment technology to identify genetic variation in the cancer.
Both EKF Molecular Diagnostics and ANGLE believe that the combination of the Parsortix system with PointMan™ technology may be advantageous for two reasons. Firstly, the PointMan™ system preferentially amplifies variant sequences of interest whilst suppressing amplification of the wild type i.e. normal DNA. As a result, it has the potential to identify all mutations in gene sequences associated with clinical utility of targeted cancer therapies. In contrast, competing genetic analysis systems generally amplify only those areas which may be predicted to be mutant and therefore may miss unexpected mutations.
Secondly, PointMan is highly sensitive with the ability to work with very low levels of target material, potentially as low as one CTC. The high purity of the Parsortix harvest (low white blood cell contamination) and its epitope independence may enable the combined system to be widely deployed across different cancer types and stages of disease.
Cancer patient blood samples will in the first instance be processed under ANGLE’s existing research collaboration with the University of Surrey and the Royal Surrey County Hospital (Guildford, UK). The University of Surrey Oncology Department has already processed 20 colorectal cancer patient samples with the Parsortix system and stored the harvested cells for analysis. This bank of samples is ready for analysis and should enable the collaboration to make rapid progress towards initial proof-of-principle.
If the collaboration is successful, EKF Molecular Diagnostics and ANGLE will explore ways to offer their respective systems as a combined solution addressing first the pharmaceutical drug trial and research use market and then, as patient data are developed, the clinical market.
ANGLE’s patented Parsortix system can harvest rare CTCs in cancer patient blood – even when there is less than one CTC in one billion healthy cells. The resulting liquid biopsy (simple blood test), using technology such as PointMan, enables the investigation of mutations in the patient’s cancer for personalised cancer care. The Parsortix system is “open-source” and has been designed to work with all existing analytical procedures in the same way that the existing solid biopsy provides cancer cells for a wide variety of analytical procedures.
Andy Webb, CEO, EKF Molecular Diagnostics, commented: “Our PointMan™ DNA enrichment technology has demonstrable performance in the detection of ultra-low level mutations. The high purity of the CTCs harvested by ANGLE’s Parsortix system and the absence of immunomagnetic beads gives us confidence that it will be effective with the Parsortix harvested CTCs providing rapid molecular information to the oncologist.”
ANGLE’s Founder and Chief Executive, Andrew Newland, commented:
“We are delighted to announce this collaboration with EKF. The combination of ANGLE’s Parsortix system with EKF’s PointMan™ system has the potential to provide a complete solution for the oncologist. We look forward to an early proof-of-principle.”
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Editors’ notes
About EKF Diagnostics - www.ekfdiagnostics.com
EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, EKF Molecular, Stanbio Laboratory, Separation Technology Inc., DiaSpect and Selah Genomics brands, specializes in the development, production and worldwide distribution of point-of-care blood analyzers for use in the detection and management of diabetes, anemia, lactate and kidney related diseases. Its new molecular division, EKF Molecular Diagnostics, focuses on technology used within the development of companion diagnostics, specifically within oncology. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.
Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement.
Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities.
Molecular Diagnostics: In March 2013 EKF set up a new division to focus on molecular and companion diagnostics following the acquisition of UK-based 360 Genomics. EKF Molecular Diagnostics’ technology, PointMan™, is capable of detecting mutant genes from tiny biopsy and blood samples and has recently entered a partnership with the world renowned cancer research center at Massachusetts General Hospital, USA.
EKF Diagnostics’ strengths lie in its multi-national research and manufacturing facilities, teams of experienced analysts and engineers in Germany, Ireland, USA and the UK, and a board led by some of world’s foremost authorities in medical diagnostics.
About ANGLE - www.angleplc.com
ANGLE is a specialist medtech company commercialising a disruptive platform technology that can capture cells circulating in blood, such as cancer cells, even when they are as rare in number as one cell in one billion blood cells, and harvest the cells for analysis.
ANGLE’s cell separation technology is called the Parsortix system and it enables a liquid biopsy (simple blood test) to be used to provide the cells of interest. Parsortix is the subject of two granted US patents and three extensive families of patents being progressed worldwide. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The Parsortix system is established with strong positive evaluations from leading cancer research centres and is working with these cancer centres to demonstrate key applications. Parsortix has a CE Mark for Europe and FDA authorisation is in process for the US.
The analysis of the cells that can be harvested from patient blood with ANGLE’s Parsortix system has the potential to help deliver personalised cancer care offering profound improvements in clinical and health economic outcomes in the treatment and diagnosis of various forms of cancer.
The increase in cancer to a 1 in 3 lifetime incidence is set to drive a multi $billion clinical market. The Parsortix system is designed to be compatible with existing major medtech analytical platforms and to act as a companion diagnostic for major pharma in helping to identify patients that will benefit from a particular drug and then monitoring the drug’s effectiveness.
Now that the Parsortix system has been developed, ANGLE is focused on its commercialisation in the market. ANGLE has established formal collaborations with world-class cancer centres and is working with these cancer centres to demonstrate key applications for its Parsortix non-invasive cancer diagnostic system as a liquid biopsy. Details are available here http://www.angleplc.com/the-company/collaborators
As well as cancer, the Parsortix technology has the potential for deployment with several other important cell types in the future.
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