TECHNOLOGY SHOWCASE Increased efficiency and faster viral load results in Italy


A newly released case study, available from Beckman Coulter, describes the experiences of Niguarda Hospital’s Molecular Biology Laboratory in the assessment of the DxN VERIS Molecular Diagnostics System. Involving fewer steps and reagents, and with true single-sample random access, DxN VERIS increased laboratory efficiency and allowed faster turnaround of viral load results. With an important Italian transplant centre


located at the hospital, cytomegalovirus (CMV) analyses are vital and results are needed without delay. In addition, the Molecular Biology Laboratory performs viral load measurements for HIV-1, HCV and HBV in order to evaluate and monitor therapeutic responses. The new DxN VERIS Molecular


Diagnostics System consolidates DNA extraction, nucleic acid amplification,


quantification and detection on a single automated instrument for a number of molecular targets, including HIV-1, HCV, HBV and CMV. Each assay is supplied in a single cartridge system, and all consumables and reagents are stored onboard the system, which cuts preparation time compared to alternative methods. In addition, the system has true single-sample random access, unlike traditional plate-based methods that


Developments in biopharmaceutical characterisation collaboration


Thermo Fisher Scientific and the National Institute for Bioprocessing Research and Training (NIBRT) have announced a scientific collaboration focused on the development of analytical solutions for the characterisation of complex biopharmaceuticals. These represent protein molecules produced by genetically engineered living cells using large-scale industrial bioprocessing. The complexity of these molecules requires advanced analytical characterisation strategies to ensure that biopharmaceuticals are produced to the highest possible quality level. This collaboration will see NIBRT


develop workflows on the Thermo Scientific biomolecule column range with its associated consumable portfolio in conjunction with sophisticated Thermo Scientific liquid chromatography systems and advanced Thermo Scientific Orbitrap high-resolution mass spectrometers. “This collaboration is important


because it enables our team to access


Thermo Fisher’s columns and analytical instrumentation to develop total analytical solutions and streamline the characterisation of complex biopharmaceuticals,” said Dr Jonathan Bones from NIBRT’s Characterisation and Compatibility Laboratory. “Analytical characterisation of


biopharmaceuticals remains a challenge for scientists and requires cutting-edge chromatography solutions and mass spectrometry detection,” said Jakob Gudbrand from Thermo Fisher. “NIBRT is an independent centre of excellence with collaborations across the major biopharmaceutical companies in the industry. “This allows them to provide valuable


insights to improve the technology, simplify analysis, generate informative characterisation data and understand these complex molecules, ultimately enabling scientists to move from sample to knowledge quickly and efficiently.” www.thermofisher.com


Pancreatic elastase and faecal M2-PK


Testing for both faecal pancreatic elastase (to measure pancreatic exocrine function) and faecal M2-PK (for colorectal cancer screening) using the same stool extract is one of the benefits delivered by the ScheBo Master Quick-Prep device. A bright orange dye added to the


extraction buffer makes it easier to see if a well has been missed when pipetting extracted samples onto the enzyme-linked


THE BIOMEDICAL SCIENTIST AUGUST 2016


immunosorbent assay (ELISA) plate, and this is another advantage that has been welcomed by users of the assay. The ScheBo Master Quick-Prep device


enables fast, convenient and hygienic preparation of stool extracts for quantitative assay with the ScheBo Pancreatic Elastase 1 stool test and/or ScheBo Tumour M2-PK stool test. www.schebo.co.uk


require samples to be batched in order to be cost-effective. “Whereas our existing method for viral


loads requires many manual steps and over 20 consumables, DxN VERIS involves much less manual intervention and just five reagents,” commented Diana Fanti, Molecular Biology Laboratory Manager. “DxN VERIS allows true single-sample


random access, which means that viral load assays can be performed as soon as they arrive in the laboratory. This, combined with short assay run times, ensures rapid turnaround of results,” she continued. “This is the most important advantage of random- access testing for us, because it transforms the availability of medical reports to the different departments.” www.beckmancoulter.com/ moleculardiagnostics


In vitro colorectal cancer screening


Epigenomics, the German-American cancer molecular diagnostics company, has announced that the US Preventive Task Force (USPSTF) has included Epi proColon in its new recommendation statement for colorectal cancer screening, published in the Journal of the American Medical Association (JAMA). In its statement, the USPSTF highlights that there is convincing evidence that colorectal cancer screening substantially reduces deaths from the disease and that not enough people are using screening tests. In the recommendation, the USPSTF


names Epi proColon (an in vitro polymerase chain reaction [PCR] assay for the qualitative detection of Septin9 gene methylation in DNA isolated from patient plasma) as one of several screening tests for the detection of early-stage colorectal cancer. Epigenomics expects that the new


USPSTF recommendation will contribute to higher colorectal cancer (CRC) screening rates, which have been stagnant over the past years. The American Cancer Society and other medical guideline bodies pursue a CRC screening goal of 80% of eligible patients. “We are excited about the inclusion of


Epi proColon in the new USPSTF recommendation, which recognises the potential role of the blood-based test in colorectal cancer screening, especially in driving patient compliance in individuals who are reluctant to collect stool samples or undergo colonoscopy,” said Dr Thomas Taapken, CEO/CFO Epigenomics. www.epigenomics.com


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