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YOUR SPECIALIST FOR LABORATORY, PATHOLOGY & HISTOLOGY www.KUGEL-medical.de 20YEARS MADE IN GERMANY Join us at the MEDICA 2015 Hall 3, Booth No E92 November 16-19, Düsseldorf, Germany Azg_KM_European-Hospital_103x133.indd 1 28.09.15 10:46 EUROPEAN HOSPITAL  Vol 24 Issue 5/15 8 LABORATORY & INFECTION CONTROL Shrouded in secrecy: a non-venous blood sampling system Drawing blood from capillariesReport: Cynthia E. Keen It hasn’t happened yet, but the labo- ratory testing industry in the United States is bracing up for a day when venous blood draws may become more of the exception than the rule. For the past two years, Theranos, a Palo Alto, California-based start up and its founder Elizabeth Holmes, the world’s youngest female billionaire, have disrupted this industry with fin- ger-prick tech- nology and lab- oratory test- ing offered at a fraction of the price of its estab- lished com- petitors like Labor ator y Corporation of America (LCA)andQuest Diagnostics. Theranos has developed a novel, proprietary blood- testing platform that uses a few drops of blood obtained via finger-stick, or with very small needles. The firm posts its prices for tests online and delivers results rapidly to order- ing physicians and patients them- selves who have downloaded the company app. The website also offers integration with electronic health systems (EHRs) to its cus- tomers. How Theranos’ proprietary tech- nologies work are shrouded in secrecy, although the company did Report: Stephane Mabic PhD and Maryse Gauthey Baraou In busy biomedical laboratories high quality, well-maintained analysers and professional competent lab per- sonnel are two ways to ensure consistently accurate results and maximise clinical analyser uptime. Another less obvious — but none- theless very important factor — is the quality of reagents, including water used to feed the analyser. Several types of contaminants must be removed from potable tap water, however, in order to attain a suitable grade of purity for use with assays. In particular, achieving a low bacteria count in pure water is critical, because bacteria can con- taminate the analyser and generate numerous interferences in biochem- istry and immunochemistry assays. Multiple effects of bacteria Gram-negative bacteria, such as Ralstonia pickettii, Sphingomonas paucimobilis, Caulobacter crescen- tus, and Pseudomonas aeruginosa can reproduce and contaminate the clinical analyser. These grow in the tubing, on-board reservoir, mani- folds, as well as in samples and reagent needles. Bacteria release enzymes and small organic acids, such as oxalate and pyruvate, which interfere with several assays, causing unstable cali- brations, high absorbance of blanks, reference drifts and errors on mean patient values. Interferences in chemistry assays – In the calcium Arsenazo assay, the bacterial proteins bind to Ca, modifying the concentration of the analyte dosed in the serum. In the potassium potentiometric assay, high coefficients of variation (CVs) and the need for recalibration were observed following a stand-by mode of the instruments; these faded away after rinsing and use of the instru- ment for some time. Interferences with enzyme immu- noassays (EIAs) – Alkaline phos- phatase (ALP) is commonly used as a detection enzyme in numer- ous biomedical methods, includ- ing enzyme immunoassays and ALP-labelled nucleic probes. Mostly Scientists at the University of Strathclyde in Glasgow have been working to identify compounds with important anti-infective activity and suitable for treating serious infectious diseases caused by bacteria and para- sites, such as Clostridium difficile. Their work has led to the creation of the new drug known as MGB-BP-3 (MGB = minor groove binder). Now, the university’s research and development partner MGB Biopharma has begun a Phase 1 clini- cal trial in healthy male volunteers to assess the safety and tolerability of the oral formulation of MGB BP-3 to treat C-Diff infections. Professor Colin Suckling, from Strathclyde’s Department of Pure & Applied Chemistry, who is the Principal Investigator in the DNA MGB (minor groove binder) technol- ogy, said: ‘Drug discovery is a major research theme at Strathclyde and we are now beginning to see real benefits by reaching the clinical trials for MGB BP-3. ‘MGB-BP-3 is a member of a fam- ily of compounds we call S-MGBs, or Strathclyde MGBs. Different S-MGBs target different infectious organisms – some against other infectious bacte- ria and others against trypanosomes – the microbes that cause sleeping sickness. ‘We have been able to tune the properties of these compounds, so that pathogens can be targeted with- out harming the patient, and look forward to taking these potential does not explain how the Theranos system works. The company claims that it is working to obtain regula- tory clearance for at least 120 dif- ferent tests, not a standard practice receive the USA’s Food and Drug Administration (FDA) clearance for a laboratory test to detect herpes simplex 1 in July 2015. However, the FDA’s detailed 29-page memo in the laboratory testing industry, in an effort to the FDA to grant formal clearance to its novel methodology. Also in July, Theranos signed stra- tegic partnership agreements with mega-pharmacy chain Walgreens, with AmeriHealth Caritas, a national Medicaid managed care organisa- tion, and with Capital Blue Cross, Central Pennsyl­ vania’s largest health insurer. All of these deals are based on the low cost and rapid turnaround of Theranos’ laboratory test- ing services. Tasso, a medical tech- nology start- up com- pany head- q u a r t e r e d in Seattle, Washington, is develop- ing HemoLink, a device for self-collection of blood samples. Information about the product has been explained in more detail by journalists rather than by the company itself. Neither its website nor its anonymous spokes- persons – the Tasso Team – offer any information. Journalist Patricia Kirk of Dark Daily describes HemoLink as a small device the diameter of a golf ball, which when placed against an arm or abdomen for two minutes will draw blood from capillaries into a small container. Gizmag reports that, by using capillary action, HemoLink lever- ages microfluidics to create a slight vacuum that pulls blood from capil- laries through tiny channels in the skin and into a small tube. The device collects 0.15 cubic centime- tres of blood. In April 2015, Tasso received a $2.6 million grant from the US Department of Defense’s Defence Advanced Research Projects Agency (DARPA) to continue work to develop the device commercially. Its development partner GenTegra received $1.3 million for technol- ogy that dries blood samples so that they can be shipped and stored without refrigeration. Currently, the companies are working together to develop an integrated device that is able to collect blood easily from patients and stabilise biomarkers at ambient temperatures without requiring cold chain transportation. Once the FDA clears these prod- ucts and technologies in develop- ment, they are expected to be used by consumers in their homes, rural areas and war zones. However, when this will happen is not yet known. Media reports suggest that HemoLink will be submitted to the FDA in 2016. When contacted, the Tasso Team stated in an email that ‘… it has no quoted timeline for this effort’. Trial pitches M against ClostriClinical trials of a new drug to treat C-Diff infections are underway in the United Kingdom. Mark Nicholls reports Theranos’ blood-testing platform needs only a few drops of blood obtained via a finger-stick Photo:Theranos Preven Ensure quality: c your clinical ana Azg_KM_European-Hospital_103x133.indd 128.09.1510:46

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