GAMBICA is the Trade Association for Instrumentation, Control, Automation and Laboratory Technology in the UK. Our insight and influence help our members to be more competitive by increasing their knowledge and impact. Together we remove barriers and maximise the market potential in our industry.
GAMBICA members are active in the following sectors:
•    Industrial automation products and systems
•    Process instrumentation and control
•    Laboratory technology
•    Test and measurement equipment for electrical and electronics industries

www.gambica.org.uk

by Dr Tolga Durak
Around the world, organizations are building next-generation research facilities intended to encourage communication, collaboration and creativity. However, these new spaces must overcome a wide range of complex challenges to meet the needs of researchers today and in the future. This article explores five important questions that should be considered in order to build an innovation space that is safe, successful and productive.

Fundamental questions for good design

Research facility design and construction is evolving rapidly, as organizations around the world strive to create work environments that meet the needs of today’s scientists. Whether these new spaces are relatively small-scale makerspaces, large pharmaceutical manufacturing plants, or tightly regulated high-containment laboratories, they are being built to foster communication, collaboration, and innovation, often in ways that depart significantly from the traditional R&D rubric. As a result, every stage of the process – from initial site assessment, architectural design, and construction and continuing all the way through to ongoing maintenance and operation – must be approached with fresh eyes. To get started, design and construction teams must consider the following five fundamental questions.
1. Who is going to work in the facility and what will they need to be successful?
Most research projects now span multiple disciplines, and laboratory spaces often need to accommodate the varied needs of biologists, chemists, engineers, physicists and/or others – all working together but with different methods. Research facility design must accommodate each specialty’s unique requirements across a wide spectrum that includes equipment, infrastructure (electrical, ventilation, etc), information technology (IT), workflow and compliance. In addition, designers must factor in flexibility, so workspaces can adapt as the research advances and needs change.
2. What is required for compliance?
Navigating regulatory boards and obtaining approvals can be a complex, time-consuming, and expensive process, especially for clinical research facilities. Typically, these structures must be constructed in compliance with Good Laboratory Practice (GLP) regulations, Good Manufacturing Practice (GMP) regulations, and other guidelines and mandates from local, state and federal jurisdictions. In addition, laboratories that research or use infectious agents or other biological hazards must comply with regulations based on the degree of the health-related risk associated with the work being conducted. The four biosafety levels (BSLs) of containment – BSL-1, BSL-2, BSL-3, and BSL-4 – aim to safeguard against the accidental release of pathogenic organisms and other biohazards and may involve airflow systems, containment rooms, sealed container storage, waste management, decontamination procedures, and security capabilities. Clearly, the challenges of compliance need to be tackled early in the design process because meeting all of the requirements can take years, which increases the risk that research priorities change and/or that key staff moves on to other projects.
3. How sustainably can we build it?
When people think about sustainable research facility design, they usually focus on power and water consumption. Granted, researchers typically use lots of heat-generating equipment (which then require complementary cooling solutions). Their labs also generally need extensive ventilation, sophisticated sensor networks, uninterrupted power supplies – as well as back-up redundancies for all of these systems. However, in a broader sense, sustainable research facility design also addresses the health and well-being of the workforce. That means air quality, natural light, workflow and productivity considerations, material selection, and all related aesthetics can drive design and construction processes as well.
4. How will the needs of this facility change?
Science is constantly evolving, and research priorities will shift over time. Likewise, technology, regulations and workforce needs will change too. Flexibility and adaptability need to be key considerations of every plan, and designers and developers have to strike a balance between short- and long-term needs. In some cases, permanent or portable modular components may be the most efficient and cost-effective options.
5. Is building the best business decision?
For some organizations, the best business decision may be to share laboratory space, rather than to build their own. Entering into a partnership, collaboration or lease agreement with an organization that is already operating a facility can expedite research results, reduce costs, ease the burden of meeting compliance requirements and even stimulate innovation. Of course, benefits like those must be weighed against potential disadvantages, such as the lack of customization, loss of control and the risks associated with failure to protect intellectual property.

Summary

Thoughtful consideration of these five key questions will help you create an innovation space that will meet your research needs today and for years to come. As you work through your answers to each one, be sure to solicit input from architects, engineers, builders and others who have the experience and expertise to guide you in the process. Adopting a team approach is essential to building a next-generation innovation space that is that is safe, successful and productive.
The author
Tolga Durak PhD
Environment, Health and Safety Office, Professional
Education, MIT, Cambridge, MA 02139, USA
E-mail: tdurak@mit.edu

A new blood test in development has shown ability to screen for numerous types of cancer with a high degree of accuracy, a trial of the test shows.

The test, developed by GRAIL, Inc., uses next-generation sequencing technology to probe DNA for tiny chemical tags (methy-lation) that influence whether genes are active or inactive. When applied to nearly 3,600 blood samples – some from patients with cancer, some from people who had not been diagnosed with cancer at the time of the blood draw – the test successfully picked up a cancer signal from the cancer patient samples, and correctly identified the tissue from where the cancer began (the tissue of origin). The test’s specificity – its ability to return a positive result only when cancer is actually present – was high, as was its ability to pinpoint the organ or tissue of origin, researchers found.

The new test looks for DNA, which cancer cells shed into the bloodstream when they die. In contrast to “liquid biopsies,” which detect genetic mutations or other cancer-related alterations in DNA, the technology focuses on modifications to DNA known as methyl groups. Methyl groups are chemical units that can be attached to DNA, in a process called methylation, to control which genes are “on” and which are “off.” Abnormal patterns of methylation turn out to be, in many cases, more indicative of cancer – and cancer type – than mutations are. The new test zeroes in on portions of the genome where abnormal methylation patterns are found in cancer cells.

“Our previous work indicated that methylation-based assays outperform traditional DNA-sequencing approaches to detecting multiple forms of cancer in blood samples,” said the study’s lead author, Geoffrey Oxnard, MD, of Dana-Farber. “The results of the new study demonstrate that such assays are a feasible way of screening people for cancer.”

In the study, investigators analysed cell-free DNA (DNA that had once been confined to cells but had entered the bloodstream upon the cells’ death) in 3,583 blood samples, including 1,530 from patients diagnosed with cancer and 2,053 from people without cancer. The patient samples comprised more than 20 types of cancer, including hormone receptor-negative breast, colorectal, esophageal, gallbladder, gastric, head and neck, lung, lymphoid leukemia, multiple myeloma, ovarian, and pancreatic cancer.

The overall specificity was 99.4%, meaning only 0.6% of the results incorrectly indicated that cancer was present. The sensitivity of the assay for detecting a pre-specified high mortality cancers (the percent of blood samples from these patients that tested positive for cancer) was 76%. Within this group, the sensitivity was 32% for patients with stage I cancer; 76% for those with stage II; 85% for stage III; and 93% for stage IV. Sensitivity across all cancer types was 55%, with similar increases in detection by stage. For the 97% of samples that returned a tissue of origin result, the test correctly identified the organ or tissue of origin in 89% of cases.

Detecting even a modest percent of common cancers early could translate into many patients who may be able to receive more effective treatment if the test were in wide use, Oxnard remarked.

Dana-Farber Cancer Institutewww.dana-farber.org/newsroom/news-releases/2019/new-blood-test-capable-of-detecting-multiple-types-of-cancer/

The clinical diagnostics, company Beckman Coulter has implemented DxH 900 haematology analysers and the Early Sepsis Indicator across the South West London Pathology (SWLP) network. SWLP is an award-winning NHS pathology partnership set up by St. George’s University Hospitals NHS Foundation Trust, Croydon Health Services NHS Trust and Kingston Hospital NHS Foundation Trust. The installation enables SWLP laboratories to provide a single, integrated pathology service to more than 3.5 million people across South West London via three hospitals, 200 GP practices and 30 community healthcare sites.
Beckman Coulter’s DxH 900 haematology analysers enable clinical laboratories like SWLP to perform complete blood count and white blood cell differential tests. Demonstrating an industry-leading 93% first-pass yield, the DxH 900 reduces the number of manual slide reviews, helping to generate reportable results as quickly as possible. In addition, the DxH 900 features the Early Sepsis Indicator, the only CE marked and FDA-cleared haematologic biomarker that aids the diagnosis of sepsis in adult patients.
Commenting on the implementation, Simon Brewer, Managing Director at South West London Pathology, said: “Emergency departments across our network see 370,000 patients a year. And, with conditions like sepsis becoming more and more prevalent, it is mission critical to have the tools and technology to identify, diagnose, and begin treatment as early as possible.”

Start Codon, a new model of life science and healthcare business accelerator, has announced its first cohort of start-up companies. Start Codon aims to minimise risk and translate early stage research into successful start-ups, ready for funding and partnership. Start Codon has worked closely with four life science and healthcare companies that were enrolled into the programme in February this year.
They are:

1. Enhanc3D Genomics, a functional genomics spin-out of the Babraham Institute (Cambridge, UK) whose platform technology links non-coding sequence variants to their target genes in order to identify novel therapeutic targets
2. Drishti Discoveries, a start-up leveraging a proprietary gene silencing technology to develop therapies for rare inherited diseases
3. Spirea, a spin-out from the University of Cambridge, who is developing the next generation of antibody drug conjugate cancer therapeutics which carry more drug payload to tumour cells, resulting in greater efficacy, tolerability and the ability to treat more cancer patients
4. Semarion, a University of Cambridge spin-out, who is revolutionising cell-based assays for drug discovery and life science through its proprietary SemaCyte microcarrier platform, which leverages novel materials physics for assay miniaturisation, multiplexing, and automation

Start Codon plans to invest in and support up to 50 start-up companies over the next five years. The accelerator is now accepting applications for its second and third cohorts of companies. Early stage start-up companies in the life sciences and healthcare space are invited to apply via https://startcodon.co/application-form