Medilink News Summer 2021 - Page 14

QuantuMDx launches its new rapid PCR point-of-care diagnostic system
Abingdon Health completes a delivery of 1m rapid antibody tests for COVID-19
Yourgene Health to provide COVID-19 testing for international arrivals

covid-19 : DIAGNOSTICS

QuantuMDx launches its new rapid PCR point-of-care diagnostic system
QuantuMDx , a Newcastle-based developer of molecular diagnostics , has launched Q-POC TM , its rapid , PCR point of care diagnostic system which is now CE-IVD marked , along with its Q-POC™ SARS-CoV-2 assay .
Q-POC™ is a portable PCR device offering rapid , sampleto-answer , molecular diagnostic testing at the point of care , with results in approximately 30 minutes . The Q-POC™ system comprises a sample collection kit , single-use test cassette and analyser . It can be used in a wide range of settings including emergency rooms , ICU , birth centres , clinics , and pharmacies .
Jonathan O ’ Halloran , Chief Executive , QuantuMDx , said : “ Q-POC™ represents a new class of molecular diagnostic device : it ’ s fast , battery operated , can multiplex and is so simple to operate that anyone can be trained to use it . It ’ s a true point of care diagnostic system .
“ Our Q-POC™ system is future-proof , and packs a great deal of complexity and power behind its modern lines and simple operation . Our SARS-CoV-2 test is just the first in a portfolio designed to meet real clinical needs . Over the next few years , we ’ ll be driving menu expansion , comprising large syndromic panels and antimicrobial resistance mutation panels , ensuring we remain at the forefront of molecular , point of care diagnostics globally .”
The launch of the diagnostic system follows on the company ’ s successful funding round of £ 11m in March .
Abingdon Health completes a delivery of 1m rapid antibody tests for COVID-19
Earlier this year , Abingdon Health , a York-based rapid test manufacturer and leading member of the UK-Rapid Test Consortium ( UK-RTC ), completed a delivery of 1m AbC-19 TM rapid antibody tests for COVID-19 .
In December , the company raised £ 22m on the AIM market of the London Stock Exchange . Since then , the business has continued to make progress on its rapid COVID-19 test , which had been the main contributor to an increase in its revenue so far .
Chris Yates , Chief Executive Officer at Abingdon Health , said : “ We have made significant commercial progress across the COVID-19 and non-COVID-19 markets and the company expects revenues to more than double this year . The company continues to develop a strong pipeline of opportunities for its AbC-19 TM rapid test . The lateral flow testing market is forecast to be worth $ 10.2bn by 2025 , and Abingdon remains well-positioned to be the ‘ go-to ’ provider for high quality rapid tests .”
Due to the growing global demand for lateral-flow tests , the company is continuing to scale up and is on track to be able to produce 150 million tests per annum by the end of 2021 .”
The company also signed a manufacturing agreement with BioSure . Under the agreement , Abingdon Health will manufacture BioSure ’ s own lateral flow tests for COVID-19 , helping speed up their roll-out in the UK and overseas .
Yourgene Health to provide COVID-19 testing for international arrivals
Yourgene Health , the international molecular diagnostic group from Manchester , has been added to the UK Government ’ s list as a private provider of day two and day eight coronavirus testing for all international arrivals for both SARS-CoV-2 PCR testing and SARS-CoV-2 genome sequencing testing services . Yourgene will provide the routine Clarigene SARS-CoV-2 PCR testing services and a new sequencing test being performed from Yourgene Genomic Services using ThermoFisher ’ s Ion AmpliSeq™ SARSCoV2 Research Panel . Lyn Rees , CEO of Yourgene Health , commented : “ Receiving approval to be added to the Government ’ s COVID-19 private provider list , for both PCR testing and our sequencing service ,
illustrates the high standard and service levels that Yourgene . has been providing under our Genomics Services offering . We are extremely pleased to be at the forefront of this development as travel begins to open up .”
The company has also been successful with its tenders under the PHE ’ s National Microbiology Framework securing four lots with the total value of £ 22bn . The lots will allow Yourgene to offer its Clarigene ® SARS- CoV-2 PCR assay and associated Manchester-based clinical laboratory testing services under the National Microbiology Framework Agreement , as well as other testing or test development services .
How healthcare and life sciences companies can make the most out of social media adrianna szczypkowska, PR OFFICER, MEDILINK NORTH OF ENGLAND Around 70% of decision makers saying that social media is influential when they’re researching or considering a new product for their company*. For healthcare and life sciences companies, social channels can act as a communication bridge connecting them with other healthcare professionals, resulting in valuable partnerships and lead generation. In this article, I explain how companies can make the most out of social platforms as part of their marketing and communications strategy. Choose relevant channels Having your company on multiple social media channels can help you increase your reach and connect with desired stakeholders more easily. However, every channel differs in terms of its purpose and type of content that works best, and so you should choose the ones that will be relevant to your communication strategy. Let’s say that your aim is to build relationships with distributors of surgical tools - in this case, a B2B-focused platform like LinkedIn could be a good first choice. Identify your target audience First, ask yourself who you want to reach with your social media content. Are they distributors of specific healthcare products? NHS clinicians? Patients? Identifying your target stakeholders will help you plan your content in terms of its purpose (e.g. informative) and messaging (e.g. ‘our product helps clinicians work more efficiently’). Include high-quality images With so many distractions, both on and offline, it is more difficult to grab and retain attention than ever before. Images say a thousand words, and you should remember this when creating social media content. Make sure to include high-quality pictures or videos in your posts. Rather than writing a long paragraph about your product or service, show how it works in an eye-catching, self-explanatory graph or a video. Engage with others Social media is useful for building networks, and you should make the most of out of it. Letting know somebody that you find their content interesting, for example by liking, sharing, commenting or tagging is a step towards building valuable and prosperous relationships, whether with healthcare distributors, clinicians or patient safety groups. Show your expertise With social media, you can share your knowledge and demonstrate your expertise at the click of a button. Have you recently read a news or a research paper referring to your area of specialisation that is worth commenting on? Share your thoughts and join discussions to show that you are up-to-date with recent developments and trends. You can also consider producing thought leadership - an informed opinion piece which usually offers guidance and insights on a specific topic, and identifies gaps in research or professional practice. Be consistent with your wording and messaging It is important that your social media content reflects the message that you want to communicate to your target audience and is an integral part of your communication or marketing strategy. For example, if you want to let your stakeholders know that your medical device is made from sustainable, biodegradable materials, make sure that this message is consistently included in your feed. *Does social media matter in the B2B purchase journey? GlobalWebIndex. 2019. Patrick Trotter PhD, MBA (Techmgmt), Head of Innovation, Commercialisation and regulatory Optimising medical technology innovation: Learning from market failure- a FIVE-step guide to reduce risk and to maximise commercial success and profitability New Product Development for the medical sector is fraught with risk and uncertainty with many medical devices, in vitro diagnostic products and new medicines failing in the market. Examples of failed medical innovations include the Pfizer Exubera Oral Insulin Delivery System. This was an inhaled insulin preparation that was launched in 2006 but withdrawn from the market in 2007 due to poor sales. The reasons for the market failure are complex, but include a poor understanding of the end users’ requirements (the device was bulky and awkward to use), a market opportunity that was much smaller than originally envisaged, a high cost, and a number of safety concerns. Furthermore, there was a failure to appreciate other solutions such as insulin pens, painless needles and the development of a number of non-insulin-based drugs that had disrupted the market. The failure to understand the market ultimately led to Pfizer making a $2.8 billion loss on the project, which is one of the largest losses in drug development history. There are numerous other examples of failed innovation in the medical space. New product development and innovation is however an important growth strategy, and without innovation few companies would be able to survive. In this short guide I highlight five simple steps, that should allow senior management to make go/no- go decisions and manage the “fuzzy” front end of innovation in a timely and cost-effective manner. • Determine the market opportunity Key tasks include segmenting and understanding the size of the opportunity and ensuring that the product meets a validated unmet need or problem. Is it meeting an unmet need and is there enough customers who want it? • Differentiate the product from competitor and alternative solutions It is critical your solution adds value not found in other solutions. Defining the intended purpose, intended population and articulating key claims and benefits during the concept generation stage allows for the innovator to benchmark the solution against other alternatives. 14 This step is critical in demonstrating the device is sufficiently differentiated from competitors and is important during due diligence to justify further investment. In addition, the intellectual property position should be clarified with regard to i) have you freedom to operate and ii) is it patentable. Protecting the innovation adds value and will help prevent competitors moving into the space. • Develop a business case for adoption It is important that the technology is aligned with mechanisms for reimbursement in the target market(s). Developing a strong value proposition aligned to the needs of the patient, the clinician and the payer will maximise the probability of commercial success. • Develop an Evidence Generation Plan (EGP) The value proposition can be used to develop an EGP that will help the innovate understand the evidence needed for successful market penetration. This stage is important in determining the resources and time necessary to commercialise the technology and will feed into both the clinical and commercialisation strategy. • Consider the regulatory strategy and plan Once the proposed concept, intended purpose and potential claims have been adequately defined, the regulatory strategy can be determined (for the key markets). This will include determination of the device classification and also ensure adequate resource has been allocated to complete the technical documentation, risk management, labelling, validation and verification of the device and the costs associated with regulatory submissions and auditing. The five steps should be incorporated into every research and development plan and should be considered in any stage gate management system to determine the resources needed for commercialisation, to reduce risk and to maximise the probability of commercial success. The article focuses on key steps to manage the front end of innovation, but within the confines of the article I have not been able to discuss how to get the information to answer the key questions - please do not hesitate to contact me should you need further advice or support. 15