Beckman Coulter, a clinical diagnostics leader, launched its Access SARS-CoV-2 IgG II assay in countries accepting the CE Mark. The new Access SARS-CoV-2 IgG II assay quantitatively measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection. The ability to establish a quantitative baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus allows clinicians to assess relative changes of an individual’s immune response to the virus over time based on a numerical value. The assay may also help researchers as they begin to understand the levels of IgG antibodies needed to be considered protective .

“Having a clearer picture of the immune response to SARS-CoV-2 plays an important role in the fight against COVID-19, especially before a vaccine is widely available,” said Shamiram R. Feinglass, MD, MPH, chief medical officer at Beckman Coulter. “Determining a quantifiable baseline is a critical step towards furthering the understanding of the adaptive immune response to SARS-CoV-2 in individuals over time.”

The Access SARS-CoV-2 IgG II quantitative assay is the latest addition to Beckman Coulter’s full suite of testing solutions designed to provide valuable information to clinicians in their fight against COVID-19. Beckman Coulter also recently launched an automated SARS-CoV-2 antigen test in the US under Policy C of the FDA’s emergency use authorization (EUA) program. While several point of care (POC) antigen tests are now available to help increase testing beyond current levels, POC tests come with workflow challenges when scaled to large patient populations. Beckman Coulter’s SARS CoV-2 Antigen test is designed to address these challenges. The organization can deliver up to 25 million tests per month, and the assay separates sample collection and processing, enabling test providers to leverage the existing infrastructure and workflows.

Results of the new Access SARS-CoV-2 IgG II test are delivered quickly on Beckman Coulter’s award-winning immunoassay analysers, including the DxI 800 high-throughput analyser, which is capable of processing up to 200 samples per hour. For more information on Beckman Coulter’s full suite of testing solutions or its commitment to the fight against COVID-19.

About the Access SARS-CoV-2 IgG II assay
The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus in response to a previous infection. The assay then provides a numerical result ranging from 2.00-450 AU/mL as well as a qualitative result for SARS-CoV-2 IgG antibodies. The test has a confirmed 99.9% specificity and 98.9% sensitivity 15-60 days post symptom onset. It uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies. The Access SARS-CoV-2 IgG II assay can be used in Random Access Mode (RAM) and seamlessly integrated into existing workflows without batch processing. The assay can also be used with a variety of Beckman Coulter analysers, including the high-throughput DxI 800 designed for large labs, to the DxI 600 for mid-sized labs and the DxCi and Access 2 analysers for smaller labs and healthcare clinics.

About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, California, and has more than 11,000 global associates working diligently to make the world a healthier place.

Kent and Medway have gone live with a booking solution which enables direct appointment scheduling from NHS 111 and NHS 111 Online.

The decision to implement the NHS 111 First Direct Appointment Booking solution was in response to a government strategy aimed at encouraging patients who require urgent and unscheduled care to call NHS 111 in order to be directed to the most appropriate service for treatment.

This may include an appointment in primary care, urgent treatment centre (UTC), same day emergency care (SDEC) or, in extreme cases, the emergency department at the local acute trust.

The NHS Kent & Medway Clinical Commissioning Group (CCG) and local providers have worked with the region’s NHS 111 provider, South-East Costal Ambulance Service (SECAmb) and WASP Software on the project.

Rather than try to implement or upgrade each provider system, the Kent and Medway region chose to work with WASP Software who provide technology that is able to sit in front of each site’s IT service and manage scheduling activity.

As a result of the solution being introduced staff no longer need to check multiple systems just to establish who is due to arrive.

Michael Brett, managing director of WASP Software, said: “The work we have been doing across Kent and Medway has been driven by the need to provide direct appointment booking into emergency services which have historically been unscheduled.

“Urgent and emergency care by their very nature are unscheduled incidents and so the challenge has been how best to manage the demand on ED during these extraordinary times.”

The agreement will involve clinical AI research being applied to anonymised data to improve patient care and accelerate research into new medicines.

All of the data supplied to Sensyne will be anonymised by Royal Wolverhampton beforehand and the trust will receive around 1.3million ordinary shares in the company. This brings the total share ownership held by NHS trusts in Sensyne to 12.6%.

The trust will also receive investment of up to £250,000 per year from Sensyne across the 5-year term. The money will be used for specific investments in NHS information technology to enable the curation and analysis of data under the agreement.

Royal Wolverhampton will also receive a royalty on revenues that are generated by Sensyne from the research undertaken as part of the agreement. The financial return the trust receives from Sensyne will be reinvested back into the NHS to fund patient care.

Sultan Mahmud, chief innovation, integration and research officer at the trust, said: “In this collaboration we will focus on improving prevention, early diagnosis and treatment of illnesses for complex patients so that we can provide anticipatory care.

“Our clinical teams and informatics colleagues are looking forwarding to working with Sensyne.”

Royal Wolverhampton joins eight existing NHS trusts that have a strategic research agreement (SRA) with Sensyne, with the most recent being Milton Keynes University Hospital NHS Foundation Trust in November 2020.

Paul Drayson, chief executive of Sensyne Health, added: “The SRA continues Sensyne’s momentum in expanding its anonymised patient data set and deepening the diversity of the therapeutic areas within it.

“This in turn helps provide Sensyne with the critical mass of data to improve patient care and accelerate medical research”.

The Royal Wolverhampton NHS Trust has signed a five-year non-exclusive strategic research agreement with Sensyne Health.

ViiV Healthcare and London’s Westminster Hospital NHS Foundation Trust have launched a digital triage service for HIV patients supported by a mobile app.

ViiV, a joint venture majority owned by GlaxoSmithKline, with Pfizer and Shionogi as minority shareholders, has been working with Chelsea and Westminster Hospital NHS Foundation Trust on the service.

The new service is being gradually launched to patients at the hospital’s Kobler Outpatient Clinic, one of the largest centres of HIV care in Europe. It is then planned to expand to larger patient populations across multiple sites at the trust in the coming months.

The organisations have already run a pilot scheme through a joint working agreement, which were presented at last year’s British HIV Association Annual Congress, showing high levels of patient satisfaction and quality of care.

The service known as Klick has also been designed to respond to the current demands on HIV healthcare services brought by the COVID-19 pandemic allowing outpatient clinics to rapidly evaluate clinical needs, provide access to care remotely and communicate effectively with patients.

Design and implementation have been led by a project team comprising individuals from ViiV Healthcare’s innovation team, along with clinical and non-clinical staff from the Kobler Clinic.

The service has been designed with a focus on ensuring digital solutions can integrate with and enhance the service model, whilst delivering a positive experience for patients.

Dr David Asboe, Clinical Director for HIV at Chelsea and Westminster Hospital NHS Foundation Trust, said: “We have made significant advances in the care of people living with HIV, but this work is not finished.

“In many regards, it has just begun. Our combined efforts have shifted HIV from an acute to a predominantly long-term condition. “It is our duty to understand the emerging needs of our patient cohort, to design care that is responsive to these needs, and to provide care in a sustainable fashion. “We must achieve these things with a backdrop of the challenges we now also face with COVID-19.

“The collaboration between the Trust and ViiV Healthcare has provided an opportunity to produce an evidence-based and practical service concept that provides a strong platform on which we can build.”

Klick service triages patients according to their clinical needs and allows them to review results, manage appointments and complete health assessments

The service, called Klick, has been developed by clinical and non-clinical staff together with HIV medicines and research company ViiV, and is intended to improve access to the most appropriate care.

The system uses digital tools to triage patients according to their clinical needs, and sits alongside a mobile app that patients can use to manage their appointments, complete health assessments, review results and communicate with healthcare professionals.

The service is being gradually rolled out to patients at one of the largest centres of HIV care in Europe, the trust’s Kobler Outpatient Clinic, and will be expanded to further sites in the next few months.

David Asboe, clinical director for HIV at Chelsea and Westminster, said there had been significant advances in care for people living with HIV.

“Our combined efforts have shifted HIV from an acute to a predominantly long-term condition,” he said. “This brings its own challenges and responsibilities. It is our duty to understand the emerging needs of our patient cohort, to design care that is responsive to these needs, and to provide care in a sustainable fashion.”

The digital service has been designed in response to the increasing demands on HIV healthcare services brought by the Covid-19 pandemic.

“We must achieve these things with a backdrop of the challenges we now also face with Covid-19,” said Asboe. “Health systems are under more pressure than ever and using new technologies in a way that genuinely enables our services to evolve is absolutely critical to ensuring we can continue to improve how we deliver quality care to our patients.”

Royal Philips, a global leader in health technology, and Vithas Group, Spain’s second largest private healthcare group, today signed a 5-year innovation and collaboration agreement in the areas of precision diagnosis and image-guided intervention. The agreement will allow Vithas Group hospitals and medical centers to benefit from the latest innovations in diagnostic imaging technology, healthcare informatics, and equipment for minimally-invasive interventional procedures. Vithas Group hospitals and clinics offer healthcare and advanced medical care in thirteen provinces in seven autonomous regions of Spain.

Under the terms of the agreement, Philips will deliver a technology management model that ensures Vithas Group’s current and future health technology needs in the relevant areas are met, together with the associated maintenance, updating, and equipment and system renewal needs. This management model will enable Vithas Group to achieve better results, provide optimal care at lower cost, and deliver a better experience for its patients and healthcare professionals.

In addition, Vithas will become a ‘reference technology partner’ for Philips in Spain, which means that its hospitals and medical centers will be able to implement new advances and innovations developed by Philips, before standard commercialization of these solutions in Spain.

This new alliance with Philips integrates cutting-edge technology, healthcare excellence, innovation, and research, which are the fundamental pillars on which we support our commitment to always seek the best experience for our patients,” said Dr. Pedro Rico, CEO of Vithas Group. “Furthermore, our professionals will have the most advanced technological solutions at all times, which will reinforce the quality of care and facilitate their research work.”

“We are very excited about the trust placed in Philips and convinced that, through this collaboration agreement, Vithas will have all the technology and innovation necessary to continue achieving the best health results and the best experience for its patients and its healthcare professionals,” said Juan Sanabria, President of Philips Ibérica. “We are proud to become the technological partner and strategic ally of a group as important as Vithas.”

The most advanced diagnostic imaging technology
The agreement includes the replacement of Vithas Group’s existing MR imaging equipment with Philips’ latest innovative MR systems, which stand out for their image quality and patient comfort, and because they do not consume helium, also stand out for their sustainability. Philips will also install hybrid operating room solutions, including its latest ceiling mounted live-image guidance system for minimally-invasive interventional therapy, allowing Vithas hospitals to perform many types of procedure with maximum precision and safety. Four new hybrid operating rooms will be installed across four of the group’s hospitals.

Next to this, Philips will replace the Vithas hospitals’ CT (Computed Tomography) equipment by high-end equipment, allowing them to perform more precise cardiac diagnoses thanks to the Philips equipment’s speed, coverage, and high image quality, while also minimizing radiation dose. The agreement also includes X-ray equipment, solutions for dose management, and a Corporate Network for Diagnostic Imaging.

Benefits of the Corporate Network for Diagnostic Imaging
Through this network, and thanks to a solution for reviewing, post-processing and sharing information from advanced medical imaging studies, more than 100 radiologists will be able to work in a unified way with access to tools that speed up and improve the quality of results. Likewise, more than 5,000 referring physicians will have higher quality radiological reports directly available to them via a clinical viewer. The solution will also improve the patient experience, because they will be able to view their reports and images from any PC or mobile device via a secure web portal.

Joint scientific research
The innovation and collaboration agreement between Philips and Vithas Group will make it possible for the two organizations to collaborate in technological innovation projects in Vithas Group reference centers. These projects will involve joint scientific research in key healthcare areas, as well as the training of Vithas Group professionals in new technologies and clinical procedures.

About Royal Philips

Royal Philips is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 19.5 billion and employs approximately 82,000 employees with sales and services in more than 100 countries.

About Vithas Group

Vithas’ commitment: accredited healthcare quality, personal service and long-term vision.

Vithas’ strategic commitment is that all healthcare is endorsed by the standards of the most prestigious international quality accreditation, the Joint Commission International. Only 15 prestigious hospitals in Spain have such accreditation and recognition, and three of them are part of Vithas, in Madrid, Malaga and Granada. Every year Vithas treats more than 5,200,000 patients in its 19 hospitals and 21 Vithas Salud medical centers. The 40 centers are located throughout Spain and include hospitals in Alicante, Almería, Benalmádena, Castellón, Granada, Las Palmas de Gran Canaria, Lleida, Madrid, Málaga, Seville, Tenerife, Vigo, Valencia and Vitoria-Gasteiz. The 26 Vithas Salud centers are located in Alicante, Elche, El Ejido, Fuengirola, Granada, Las Palmas de Gran Canaria, Lleida, Madrid, Malaga, Nerja, Pontevedra, Rincón de la Victoria, Sanxenxo, Seville, Torre del Mar, Torremolinos, Vilagarcía de Arousa, and Vitoria-Gasteiz. Additionally, Vithas has more than 300 locations throughout Spain as part of the Vithas Lab laboratories network. Its PlazaSalud24 purchasing center, a benchmark in the sector, serves 39 hospitals, 35 medical centers and 20 dental clinics.

Candela, a leading global medical aesthetic device company, announced the availability of the Frax Pro™ system. The FDA-cleared, non-ablative fractional device is the first platform featuring dual-depth skin resurfacing with both Frax 1550™ and the novel Frax 1940™ applicators. The two modalities target different skin layers, stimulating growth of new collagen, revealing smoother, more brilliant skin. The Frax 1940 handpiece delivers a 1940 nm wavelength laser beam for a shallow, epidermal approach, with focal reach extending to approximately 200 µm in depth. The 1550 nm wavelength of the Frax 1550 handpiece penetrates deeper, with histological analysis showing up to 800 µm penetration. Clinical studies demonstrate high rates of textural improvement and patient satisfaction with the Frax 1550 and Frax 1940 handpieces.

“With use of both applicators achieving dual depth resurfacing, we saw a complementary effect,” says Jill Waibel, MD of Miami Dermatology and Laser Institute. “Additionally, patients treated in our clinic were extremely pleased with new Frax 1940 treatment results. The outcomes clearly demonstrated intended results of skin resurfacing with improvement in both textural irregularities and skin tone.”

The Frax Pro system revolutionizes the aesthetic space by removing limitations of earlier fractional 1550 nm, 1565 nm and/or 1927 nm laser systems. High return on investment (ROI) treatments of the Frax Pro system make it a wise approach to managing practice costs when compared to a leading competitive device. The Frax Pro system’s exclusive 100% applicator-confined diode laser technology and a reductive design, allows a lightweight, flexible umbilical for a comfortable, ergonomic reach and improved treatment visibility relative to thulium-based systems. Multiple laser scan widths enable more customized treatments. These innovations, along with magnetic roller sensing technology and integrated clinical intelligence for quick learning and data retrieval, are just some of the ways that the Frax Pro system advances the space of non-ablative fractional laser therapies, making it the “smart way to Frax”.

Both the Frax 1550 and Frax 1940 technologies are also available on, and interchangeable with, the NordlysTM platform. This addition makes the Nordlys system the first in its class to provide dual fractional 1550 nm and 1940 nm wavelengths, as well as IPL and Nd:YAG capabilities.

“The Frax Pro and Nordlys systems, both with Frax 1550 and Frax 1940 applicators, extend our legacy of innovation in non-ablative treatments,” says Geoffrey Crouse, Chief Executive Officer of Candela. “Candela has a long history of technological innovation and bringing to market best-in-class medical aesthetic energy-based devices, and we are proud to share this new offering.”

Spinal Elements, a spine technology company, announced the FDA clearance of the Lucent® XP-Curved Expandable Interbody Device. Lucent XP-Curved is the third platform in the Lucent XP family of expandable devices and the fifth expandable device within Spinal Elements’ MIS Ultra™ suite of products and procedures. The device and its instrumentation allow for the steerable placement of the intervertebral implant followed by the expansion of the implant’s height once surgically placed. The company’s line of expandable devices has demonstrated impressive adoption and growth, and the company believes this addition will continue that success.

The Lucent XP-Curved device will come in three lengths with multiple lordotic options of up to 15° to assist surgeons in restoring normal spinal alignment and balance during open or MIS TLIF approaches. The devices comprising the Lucent XP family are made primarily of polyetheretherketone (PEEK) and feature Spinal Elements’ Ti-Bond® porous titanium coating. Ti-Bond is a hydrophilic porous titanium coating with nano-scale surface features that has been used in tens of thousands of Spinal Elements fusion procedures.

Matt Colman, M.D. of Rush University Medical Center in Chicago, IL says of the Lucent XP-Curved system, “Lucent XP-Curved contains the ideal combination of TLIF device attributes. I can perform cantilever segmental correction using a more ALIF-like footprint while taking advantage of the benefits of in-situ expandability. Additionally, the radiolucency of the PEEK and Ti-Bond construction allows me to confidently assess the healing process throughout the patient’s recovery, providing increased surface area and stability while promoting fusion.”

Wade Jensen, M.D. of the Center for Neurosciences, Orthopedics, and Spine (CNOS) in Dakota Dunes, SD adds, “With up to 15° of lordosis, I expect the expandable Lucent XP-Curved device to restore height while optimizing lordosis to achieve sagittal correction, which is critically important to long-term successful outcomes.”

“We are thrilled to add this device and procedural solution to the MIS Ultra portfolio. With the recently announced acquisition of the Orbit discectomy technology and the introduction of new expandable platforms such as Lucent XP-Curved, Spinal Elements is able to provide an increasing number of comprehensive solutions to our spine surgeon customers,” stated Jason Blain, President and CEO of Spinal Elements.

The commercial introduction of the Lucent XP-Curved device is expected in the coming months. Spinal Elements introduced the MIS Ultra platform last year. Traditionally, MIS procedures have been focused on the size of the incision required for access to the spine. The MIS Ultra product suite goes beyond small incisions to consider the implications of spine surgery after the procedure has taken place. The surgical instruments of the MIS Ultra platform have been designed to reduce the disruption of the patient’s skeletal and muscle tissue, and the implants have been designed to balance the loads shared between the implants and the body while not disrupting the patient’s surrounding healthy anatomy.