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Apollo Hospitals partners Behold.ai for X-ray technology

India-based Apollo Hospitals Group unit Apollo Radiology International has partnered with UK-based artificial intelligence (AI) radiology firm Behold.ai to use X-ray technology for rapid Covid-19 diagnosis.

The partners will work together on a pilot programme that will involve the use of Behold.aiโ€™s โ€˜instant triageโ€™ AI-based chest X-ray technology for quick triage of suspected patients.

Behold.ai will provide its red dot algorithm through Apollo Radiology International to Apollo Hospitalsโ€™ network of 71 hospitals in India, amounting to 12,000 beds.

The red dot algorithm takes 30 seconds to diagnose chext X-rays as normal or abnormal, said Behold.ai. This โ€˜instant triageโ€™ is expected to be beneficial than standard human-read processes.

In the UK and Europe, the algorithm secured the CE-Mark approval, along with the US Food and Drug Administration (FDA) clearance. The technology is expected to be deployed in the US later this year.

behold.ai chairman and chief executive Simon Rasalingham said: โ€œOur technology has been proven to rapidly diagnose chest X-rays as โ€˜normalโ€™ or โ€˜abnormalโ€™ accurately, potentially allowing for faster diagnosis of individuals with Covid-19 and the better management of resources in healthcare systems already stretched by the increase in hospital admissions.

โ€œIf successful, this infinitely scaleable pilot programme could make a significant difference to hospitals across India and the rest of the world struggling to manage the Covid-19 pandemic.โ€

As part of the pilot programme, the algorithm will also be implemented at certain domestic government-run hospitals in the country.

Apollo Radiology International CEO Dr Sreenivasa Raju Kalidindi said: โ€œRadiology reporting for Covid-19 has to be easily accessible, quick and accurate so that immediate decisions can be made on the next steps. To achieve these goals, Apollo Radiology International is setting up a dedicated centralised Covid-19 reporting service.

โ€œBehold.aiโ€™s chest X-ray algorithm will be an important component of this service. The instant triage provided by this algorithm will be a key factor that will allow our radiologists to provide immediate reports for these patients.โ€

India’s SCR develops robotic device for hospital careIndia’s SCR develops robotic device for hospital care

India's SCR develops robotic device for hospital careIndia's SCR develops robotic device for hospital care

South Central Railway (SCR) in India has developed a robotic device, called Rail-Bot (R-BOT) to aid in hospital management associated with patient care amid the Covid-19 pandemic.

Following extensive trails and demonstration, the R-BOT has been deployed for use at Central Railway Hospital in Lallaguda, Secunderabad. It is being used to supply medicines, medical accessories and to serve food to the patients.

This is expected to mitigate physical contact and reduce the risk of exposure for the doctors, nurses and other support medical staff.

The R-BOT can be run using a new mobile application supported by Wi-Fi facility and radio frequency (RF) remote controller.

In a statement, SCR said: โ€œThe Innovation, developed by Shri Hem Singh Banoth, additional divisional railway manager, Hyderabad division, SCR and his team, has come in for praise from the Zoneโ€™s head, Shri Gajanan Mallya, General Manager, SCR.

โ€œShri Mallya, termed it as a good attainment to strengthen medical care management, particularly in the prevailing Covid -19 Pandemic Virus situation.โ€

The R-BOT is equipped with sensor based features to record the patientsโ€™ body temperature and transmit the reading to the mobile phone. It can alert medics in case of abnormally high temperature readings.

It also has real-time video camera with pan and tilt functions, with two way audio and video communication as well as recording, to enable interaction between patients and doctors.

The robotic device leverages infra-red technology to facilitate communication even in darkness. It features eight direction motion control and observation avoidance sensors along with motion detection to avoid any foreign object in its way.

SCR plans to further innovate and develop the robotic device for optimal functional efficiency and enable broader use at medical facilities.

When to File for a Personal Injury Lawsuit

Personal injuries can occur anywhere, at work, homes, or public places. They can range from car accidents, factory accidents, or injuries from conflicts. Resultantly, they cause financial losses, bodily harm, and other unbearable inconveniences.

To manage the consequences of personal injuries, people seek compensation from insurance companies or the parties at fault. Due to the technicalities of contract documents, financial power of insurance firms, and authority from parties like employers, getting a fair compensation can be difficult.

Hence, we’ve enumerated a list of events where you can file a personal injury lawsuit against the party at fault. Below are the pre-requisites and general guidelines that offer a threshold for filing a lawsuit.

  1. Negligence of the Other Party

An accident may involve numerous parties and consequently, they may experience some losses. If the accident was caused by the acts of omission or commission of another party, theyโ€™re held liable.

Incidences that depict negligence may include the following:

  • Work Place Accidents: Various hazards can occur in factories, warehouses, mining operations, or other work-related buildings. If the employer conducts shoddy workmanship that leads to your injury. The employer will be liable to pay you for bodily harm, trauma, and miscellaneous losses the employee suffers as a result.
  • Pets Carnivorous pets like dogs pose a safety risk to the general public, if not handled properly. Anybody who suffers from a dog bite, without any provocation, can seek compensation from the dog owner.
  1. Medical Expenses

Accidents differ in severity and the general harm caused to an individual. Serious accidents like those involving cars may cause internal injuries, broken limbs, paralysis, post-accident trauma, and miscellaneous serious injuries.

All these effects may be very daunting when seeking treatment. The expenses may require surgeries, specialized doctors, or life support care, all of which may prove too costly for you.

In this regard, a Personal Injury Lawsuit can help you in the following ways: –

  • Urgent treatment: A lawyer can help compel insurance companies or the aggressor to speed up the payment. Normal processes may not be friendly for emergency cases and therefore a lawsuit helps improve your chances of recoveryโ€”by the settlement amounts.
  • Insufficient payments: Insurance companies or other defendants can give you a settlement that does not fit the injury. A lawsuit can help you get full settlement including future medical expenses, supporting healing aides like a wheelchair, walking dogs, and other specialized treatments. Lawyers have a wide experience dealing with these kinds of cases and will structure your case accordingly, to help you get a suitable and sufficient deal to cover for your health.

Medical expenses have a high probability of making you bankrupt or financially crippled. It’s therefore wise to put in some thought before accepting any medically related compensation.

  1. Income Compensation

There are accidents that either temporarily affect your ability to earn or deny you the chance to earn completely. Compensation thatโ€™s given to you, may not necessarily compensate for the loss of your income. This is critical because it helps to solidify the dignity and purpose of people in their lives.

Thus, in this situation a lawsuit can help you find the following compensation: –

  • Lost Opportunities: A personal injury can be the barrier between money-making opportunities. This may not be found in any compensation settlement. Negligent parties are liable to pay you for the losses youโ€™ve to suffer as a result of their fault.
  • Future income: Personal injuries may cause paralysis or lost limbs; this could mean your way of making fortune is deeply affected. A lawsuit can help you maximize the payout to cushion you from the future inability to earn a living.

Aspects like income compensation, may seem light on the eyes of the victims and the aggressor. A lawyer can help craft lawsuits or compensation argument to help secure income generation for any party.

  1. To Act as a Deterrent Measure

When accidents occur, they leave a trail of destruction. This includes bodily harm, financial loss, trauma, and other inconveniences. These effects sometimes cause permanent damage to the lives of the affected parties.

A lawsuit can help prevent future injuries or effects on the members of the public. Those found liable for negligence can be compelled by the courts to make changes that would help tame such incidences. Fines, damages, and cash awarded to victims can also help discourage such acts.

A sense of responsibility is needed to secure public safety and discourage acts of negligence.

  1. If You Receive an Insufficient Compensation

The likelihood of getting compensation after an accident is high. This doesnโ€™t negate the fact the party that caused your injury, may want to pay you the least possible compensation. If the insurance company of the person that injured you offers to pay an insufficient amount, youโ€™ve a right to correct compensation.

Lawyers can help draft lawsuits that poke holes in insurance documents and policies. Theyโ€™ll also help assert authority to the defendant as you seek the rightful compensation.

You must take the following steps before filling for lawsuits after an injury:

  1. Determine Whether the Case is Within Statute of Limitation

After the accident occurs, so much happens in between that can make your potential case time invalid. Every state or nation has its statute of limitation that helps in the expedition of such matters. This, therefore, need to be established before proceeding with the case.

A lawyer can help you to revive such time-barred cases or put the matter on a speedy lane to ensure justice is served. This can be due to a lengthy spell in hospital or when some of the affected people have lost lives in the accidents.

  1. Find an Experienced and a Competent Lawyer

One of the factors that increase your chances of success in litigation is the person representing you. An attorney for personal injury matters cannot be the same as the one dealing with other matters like family law.

Below are some top considerations to help you solve this point: –

  • Contingency Fee: Depending on your financial situation, sometimes it can be difficult to go for a lawsuit due to legal fees. Legal firms that charge no upfront fee can help you to get justice with less strain on your finances.

Look for firms that have options to charge a commission for the compensation plan.

  • Reputable Law Firms: Reputation comes from the experience in the industry and also reviews from past clients. Look for sources either online, from friends, recommendations, and peer reviews to help settle for reputable firms.

Before you embark on a legal case, the team thatโ€™s going to handle your case must be solid and competent. This is a critical step when seeking justice or fair compensation.

  1. Ensure you Have a Traceable and Accurate Record of Events

Evidence and records are the determining factors for a case to be successful or not. This is what will be used by defendants, the judge, lawyers, and members of the jury to decide your case. Therefore, take ample time to gather all that is needed.

You may require the following evidence: –

  • Medical Records: Consult a medical professional to help you gather all the required medical records and certificates. These documents will offer a weighty, balanced, and objective approach which will form the basis of deciding the case merits.
  • Photographs: Lawyers can help you gather all the necessary images that can be relied on to dispense the case. Without such critical images, the case may get difficult to prove.
  • Witnesses and Social Media Evidence: Ensure you record contacts of witnesses. Also, ensure theyโ€™re willing to back your case when seeking compensation. Also, avoid commenting about your case on public forums such as social mediaโ€”this jeopardizes the administration of the case.
  1. Select and Notify the Defendant in the Case

The ultimate reason for pursuing a case is getting justice and compensation. This can only be achieved if theyโ€™ve the abilityโ€”deep pocketsโ€”to handle the compensation.

Look for signs like a financially stable insurance company, a wealthy individual, the fault of an employer to observe safety standards, or a fault by local or federal governments.

Ensure theyโ€™re also notified to prepare for the defense. This could also precipitate out of court settlement, thus proving beneficial to all parties.

  1. Prepare the Case with your Lawyer

The final thing is preparing the case to present in the court. Your lawyer will prepare witnesses, finalize the evidence, and gather all records, on your behalf. This step culminates by filing of the case at the office of the clerk.

Whatโ€™s the Ideal Time to File a Personal Injury Case?

If youโ€™ve suffered a personal injury that affected your mobility, ability to earn, or caused you trauma, and emotional anguish, youโ€™re justified to file a case. The compensation received or offer may be insufficient to cover the losses, medical expenses, and the inconveniences brought to your life.

Itโ€™s advisable to file the case only when, backed by sufficient evidence, competent attorney and a feasible defendant.

DKSH partners with International SOS to safeguard staff and supply chain operations during COVID-19

DKSH partners with International SOS to safeguard staff and supply chain operations during COVID-19

DKSH, Asiaโ€™s leading Market Expansion Services provider for companies seeking to grow their business in Asia and beyond, has entered into a partnership with International SOS, to run DKSHโ€™s Total Quarantine Solution in several markets across Asia.

International SOS is the worldโ€™s leading medical and security company which engages more than 11,000 multi-cultural medical, security and logistics experts to help organizations fulfill their Duty of Care responsibilities and ensure workforce resilience.Recognizing the unprecedented situation, DKSH selected International SOS as partner because of their vast experience with pandemics,as they have advised many companies as well as hospitals and healthcare players on how to establish an appropriate pandemic response plan.

Together with infectious disease experts, clinicians and doctors from International SOS, DKSH has developed a unique โ€œTotal Quarantine Solutionโ€, effectively mirroring hospital procedures during a pandemic, with strict quarantine protocols in place.This solution reflects DKSHโ€™s entrepreneurial and collaborative commitment to remain the trusted partner during these challenging times.

A critical player in the global supply chain, DKSH provides healthcare products to hospitals, clinics, pharmacies and retail stores; groceries and consumer goods to stores; specialty chemicals and ingredients to manufacturers; and technology products to businesses and laboratories. As such, DKSHโ€™s supply chain must remain intact with as little disruption as possible during this unprecedented pandemic.

While facing the challenges that COVID-19 has brought, DKSH quickly recognized the need to put in place measures that safeguard its employees and operations in distribution centers across the world. Only through rigorous checks as well as health and hygiene measures in each distribution center could the company ensure that quarantine-like conditions provide protection to all staff.

Dr. Shamandree Govender, Global Medical Advisor from International SOS commented: โ€œDKSH has a robust approach in protecting the safety and health of their staff. The customized Total Quarantine Solution on-site includes daily temperature monitoring, implementing appropriate preventative rules,quarantine processing tents for screening of employees and visitors, educational and awareness-raising webinars and ensuring compliance with government regulations and legal requirements. With the Total Quarantine Solution,DKSH is able to prioritize employeesโ€™ health in all their distribution centers, which ultimately also translates to safeguarding the health and safety of the customers they serve.โ€

Dan Culver house, Head of Supply Chain for DKSH, stated: โ€œThis pandemic has shown us more than ever that we truly live our purpose: enriching peopleโ€™s lives, by continuing to provide the products our communities need. As front line workers, our dedicated staff still needs to visit hospitals, supermarkets and shops and is not able to stay at home and isolate. Thanks to the Total Quarantine Solution however, we are able to maintain our operations, while protecting our staff and ensuring business continuity to serve our local communities across Asia.โ€

About International SOS Group of Companies
The International SOS Group of Companies is in the business of saving lives, protecting your global workforce from health and security threats. Wherever you are, we deliver customized health, security risk management and wellbeing solutions to fuel your growth and productivity. In the event of extreme weather, an epidemic or a security incident, we provide an immediate response providing peace of mind. Our innovative technology and medical expertise focus on prevention, offering real-time, actionable insights and on-the-ground quality delivery. We help you meet compliance reporting needs for good governance. By partnering with us, organisations can fulfil their Duty of Care responsibilities, while empowering business resilience, continuity and sustainability.

Founded in 1985, the International SOS Group is trusted by 11,000 organisations, including over half of the Fortune Global 500, multi-national corporate clients and mid-size enterprises, governments, educational institutions and NGOs. 11,000 multi-cultural medical, security and logistics experts stand with you to provide support & assistance from over 1,000 locations in 90 countries, 24/7, 365 days.

About DKSH
DKSH is the leading Market Expansion Services provider with a focus on Asia. The Group helps companies to grow across the Business Units Healthcare, Consumer Goods, Performance Materials and Technology. The service portfolio covers sourcing, market insights, marketing and sales, eCommerce, distribution and logistics as well as after-sales services. Publicly listed on the SIX Swiss Exchange, the Group operates in 36 markets with 33,350 specialists, generating net sales of CHF 11.6 billion in 2019. With its Swiss heritage, DKSH has been deeply rooted in Asia Pacific since 1865.

Medtronic unveils results from Melody TPV and Harmony TPV clinical trials

Medtronic unveils results from Melody TPV and Harmony TPV clinical trials

Medtronic has unveiled results from two clinical trials, which evaluated its Melody Transcatheter Pulmonary Valve (TPV) Therapy, and Harmony TPV.

The ten-year data from Melody TPV study showed positive hemodynamic and safety outcomes, while the investigational Harmony TPV trial met safety and efficacy endpoints for hemodynamic function.

Medtronic vice president and general manager Sandra Lesenfants said: โ€œAs demonstrated by these late-breaking studies, weโ€™re consistently building our body of new, short-, and long-term research around innovative, minimally-invasive TPV solutions for CHD patients.

โ€œThese Harmony data demonstrate our commitment to generating new therapies and growing our congenital heart disease program to support a lifetime of care that this patient population needs.โ€

Congenital heart disease (CHD) is a common type of birth defect in the US, and approximately 22% of CHD patients have structural malformations that disrupt the connection between the heart and the lungs, known as the right ventricular outflow tract (RVOT).

Some of the patients with RVOT require an open-heart surgery early in life to correct the malformations and a prosthetic conduit can be used to increase the blood flow from the heart to the lungs.

The Melody TPV is implanted to restore pulmonary valve function and delay surgical intervention, when the conduit fails to function.
Melody is the worldโ€™s first FDA approved transcatheter valve implanted in a human

The medical devices firm, under the Medtronic congenital heart disease programme, is evaluating the safety and effectiveness of the Harmony TPV for patients with RVOT malformations.

The Melody TPV clinical trial enrolled 150 implanted patients and pulmonary regurgitation (PR) was set as primary indication for intervention. The safety outcomes includd serious device-related adverse events, stent fracture, catheter reintervention, surgical conduit replacement, and mortality rate.

The clinical trial evaluated Melody for long-term functionality, or TPV dysfunction, defined as reoperation, catheter reintervention, or hemodynamic dysfunction.

Medtronic claimed that its Melody is the worldโ€™s first transcatheter valve implanted in a human and the first to be approved by the Food and Drug Administration (FDA).

Harmony TPV has been designed to treat patients with RVOT anomalies who develop severe PR, when a previous repair fails. The study of Harmony is aimed at evaluating the safety and effectiveness of a minimally invasive alternative to open-heart surgery.

The clinical trial evaluated the procedural success, safety, and performance of the Harmony TPV device, in 50 patients enrolled across 12 sites in the US, Canada and Japan.

Clinical trial principal investigator John P Cheatham said: โ€œThese pivotal data support the rationale for a potential new therapy designed specifically for the right ventricular outflow tract.

โ€œIf future study data continues to be strong, weโ€™re hopeful that Harmony may potentially impact this critical, hard-to-treat segment of patients, who have limited treatment choices with current transcatheter technologies.โ€

Ortho Clinical Diagnostics gets CE mark for Covid-19 IgG antibody test

Synergy Laboratories Adds Medical Testing Expertise to Fight the Coronavirus and COVID-19

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, announced its second COVID-19 antibody testโ€”the VITROSยฎ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test) received CE Mark. The test offers 100% specificity.

“The observed 100% specificity with Ortho’s VITROS SARS-CoV-2 tests allows an extremely high level of confidence so that people will not be identified as having an immune response to the virus when in fact they do not,” said Christopher D. Hillyer, MD, President and CEO, New York Blood Center. “Statistically, the chance of error rises dramatically even with a very small decline from 100% in specificity, given our understanding of the prevalence of the COVID-19 virus today.”

“Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity,” said Chris Smith, Ortho Clinical Diagnostics’ Chief Executive Officer. “During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”

Ortho’s COVID-19 IgG antibody test detects the IgG antibody. It closely follows the introduction of Ortho’s COVID-19 Total test and the two tests offer greater choice in tracking and surveillance, patient management, and screening convalescent plasma. Both of Ortho’s tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus.

Ortho’s COVID-19 IgG antibody test received Emergency Use Authorization from the U.S. Food and Drug FDA administration on April 24, 2020. Ortho’s total antibody test received CE Mark on May 8, 2020 and FDA Emergency Use Authorization on April 14, 2020.

The tests run on Ortho’s high-throughput, fully automated analyzers including its flagship VITROSยฎ XT 7600 Integrated System, the VITROSยฎ 3600 Immunodiagnostic System, the VITROSยฎ 5600 Integrated System and will soon be available on VITROSยฎ ECi/ECiQ Immunodiagnostic Systems. Ortho has over 5,600 Immunodiagnostic systems installed around the world. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.

Ortho is manufacturing the COVID-19 IgG antibody tests at its Pencoed, U.K., facility. It plans to manufacture several million tests in the coming weeks.

Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. For more information visit: https://orthoclinical.info/369C1WF.

Ortho’s COVID-19 IgG antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use. Patients should consult with their health care provider to discuss antibody testing and back-to-work options.

The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. ยง263a, to perform moderate or high complexity tests. The VITROS Antibody tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. ยง 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.

Because Every Test is a Life, we never stop innovating to offer streamlined, sustainable laboratory solutions that deliver fast, accurate, reliable test results that support exceptional patient care.

As a trusted partner of hospitals, hospital networks, blood banks, and labs around the world, we proudly serve the clinical laboratory and transfusion medicine communities with customized solutions that enhance clinical outcomes, improve lab performance, overcome staffing challenges and better manage costs.

We are powered by Ortho Careโ„ข, our global, award-winning, holistic approach to service, which supports customers with best-in-class technical support, award-winning field support, and remote service and inventory support.

Roche launches new blood gas digital solution designed to improve patient care

Roche launches new blood gas digital solution designed to improve patient care

Rochc announced the CE mark availability of Roche v-TAC, a new digital diagnostic solution that allows clinicians to obtain results for arterial blood gas values from patients with respiratory or metabolic abnormalities via a simpler, less invasive venous puncture through the use of a digital algorithm.

Blood gas analysis is typically used in hospital point of care (POC) settings, where quick and accurate results are needed. This includes emergency rooms, intensive care units and operating rooms. The analysis provides clinicians with information about a patientโ€™s pulmonary function and acid?base status, both of which are essential to make a diagnosis, provide treatment and monitor progress.

A traditional blood gas test requires the collection of an arterial blood sample, which can be a painful experience for the patient since most arteries lie deeper in the tissue than veins and have a thicker wall to be punctured. This procedure is usually carried out by medical doctors or specially-trained staff. Through the Roche v-TAC digital solution, staff without specific training to draw arterial blood samples are now able to withdraw a venous blood sample instead and digitally convert these values into arterial blood gas values, which can help free up specialist healthcare staff to other tasks. Rocheโ€™s v-TAC is fully integrated for use with Rocheโ€™s cobas b 123 POC and cobas b 221 systems using the Roche cobas infinity POC solution.

โ€œIn an emergency situation such as the COVID-19 pandemic, Roche v-TAC could also help healthcare professionals to assess disease severity faster in patients and closely monitor potential deterioration in patients with respiratory compromise,โ€ said Thomas Schinecker, CEO Roche Diagnostics. โ€œDigital tools based on clinical algorithms like Roche v-TAC can help improve and simplify delivery of care in emergency situations faster and where it is most needed.โ€

Roche acquired the v-TAC technology at the end of March with the acquisition of Obi Medical Aps, a privately-held company based in Hadsund, Denmark that focuses on developing disruptive blood gas testing technology.

About Blood Gas testing
Blood gas and electrolyte testing is used in a number of critical care situations, during surgery and in a number of other clinical areas, including neonatal and dialysis units. For example, it can help determine whether a patient is receiving sufficient respiratory support, or suffering from heavy trauma or acute heart and lung diseases.

Blood gas and electrolyte systems provide fast, accurate, quantitative measurements of whole blood for pH, pCO2, pO2, Sodium , Potassium , Chloride , Calcium, Glucose, Lactate, Haematocrit, Total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb).

About Rocheโ€™s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need.

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Our existing diagnostics portfolio for critical care has also been playing a significant role in supporting patient management during the COVID-19 crisis, with our blood gas and sepsis products being used to monitor patients in the acute setting. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.

While there are currently no approved medicines for the treatment of patients with COVID-19, we are actively involved in understanding the potential of our existing portfolio and are researching options for the future. On 19 March, we announced the initiation of COVACTA – a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemraยฉ/RoActemraยฉ (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. Roche has also initiated an internal early research programme focused on the development of medicines for COVID-19 and is evaluating a large number of potential collaborations.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve peopleโ€™s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare โ€“ a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the worldโ€™s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

FDA approves Roche’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer

Roche announced that the US FDA has approved Tecentriq as a first-line treatment for adults with metastatic non-small cell lung cancer whose tumours have high PD-L1 expression (PD-L1 stained โ‰ฅ 50% of tumour cells [TC โ‰ฅ 50%] or PD-L1 stained tumour-infiltrating [IC] covering โ‰ฅ 10% of the tumour area [IC โ‰ฅ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.

โ€œWe are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,โ€ said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. โ€œToday marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.โ€

This approval is based on an interim analysis from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40โ€“0.89; p=0.0106) in people with high PD-L1 expression (TC3/IC3-wild-type [WT]). Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified. Grade 3โ€“4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.1

Tecentriq is the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks. The supplemental Biologics License Application for the Tecentriq monotherapy was granted Priority Review, a designation given to medicines the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

In the US, Tecentriq has received four approvals across NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies. It is also approved in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a personโ€™s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
Rocheโ€™s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve peopleโ€™s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare โ€“ a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the worldโ€™s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Everlywell gets FDA EUA status for Covid-19 Test Home Collection Kit

Vibra Health Laboratory Scales its Operation to Support COVID-19 Testing with Rapid Turnaround Time

Everlywell has secured an emergency use authorisation (EUA) from the US FDA for its Covid-19 Test Home Collection Kit, which can be used with certain authorised tests.

The EUA status allows the usage of Everlywellโ€™s kit by individuals at home who were screened using an online questionnaire that is examined by a health care provider. It helps an individual to self-collect a nasal sample at home using Everlywellโ€™s authorsed kit.

The regulator has also authorised two Covid-19 diagnostic tests, which need to be conducted at specific laboratories, for use with samples collected using the Everlywell Covid-19 kit. Under separate and individual EUAs, the regulator has authorised both tests.

Additional tests are expected to be authorised for use with the Everlywell at-home collection kit in the future, said the regulator.

The EUA status enables Everlywell Covid-19 kit to be used for the testing of a sample collected from inside the patientโ€™s nose using the authorised self-collection kit, which contains nasal swabs to collect a sample and a tube filled with saline to ship the sample back to a specified lab.
Fulgent Therapeutics and Assurance Scientific Laboratories are authorised to test specimens collected using Everlywell kit

Fulgent Therapeutics and Assurance Scientific Laboratories are the labs authorised for the testing of specimens collected using the Everlywell at-home collection kit.

The patients can collect the results via Everlywellโ€™s independent physician network and their online portal.

Currently, the Everlywell home-collection kit is claimed to be the only authorised Covid-19 at-home sample collection kit for use with multiple authorised Covid-19 diagnostic tests.

The FDAโ€™s Center for Devices and Radiological Health director Dr Jeffrey Shuren said: โ€œThe authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure.

โ€œTodayโ€™s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.โ€

Recently, The FDA granted EUA status the Covid-19 laboratory developed test (LDT), at Rutgers Clinical Genomics Laboratory (RCGL).

Oxford Immunotec releases the T-SPOT Discovery SARS-CoV-2 kit

ERT Delivers Actionable Insights to Identify COVID related Clinical Trial Risks

Oxford Immunotec Global PLC, a global, high-growth diagnostics company, announces the release of the T-SPOT Discovery SARS-CoV-2 test kit. This kit is for research use only and launched under the T-SPOT Discovery brand. This research kit could make a significant contribution towards development of a new tool to manage the COVID-19 pandemic, which in turn could help to bring nations out of their current lockdowns in a faster, safer and more controlled manner.

T-SPOT Discovery SARS-CoV-2 builds on Oxford Immunotecโ€™s experience with TB diagnosis and the assessment of immune response to CMV in transplant patients, to apply the Companyโ€™s established, proprietary T-SPOT technology to the fight against COVID-19. While serology is able to detect antibodies to SARS-CoV-2 in the blood of some individuals after infection, little is currently known about how this confers immunity to COVID-19. T-SPOT technology goes further than simple serology by interrogating the immune systemโ€™s T cell response and will enable research into the measurement of the strength of that response to SARS-CoV-2. The strength of this response may be linked to protection from reinfection.

T-SPOT technology is a proven technology, approved for clinical use to detect TB infection in over 60 countries including the US, China, Japan and Europe.

With over 20 million clinical tests manufactured since release, T-SPOT technology:

  • Uses a standardized sample prepared from peripheral blood which:
  • Reduces the influence of factors which might affect results, such as other treatments
  • Standardizes cell numbers in the test to normalize for cell number variations between samples
  • Allows the number of responding T cells to be enumerated for a more precise assessment of the T cell response
  • Is able to maintain performance, even in samples from immunosuppressed individuals
  • Can be run in high-volume labs enabling large testing programs to be rolled out

T-SPOT technology can also be automated using the T-Cell SelectTM reagent kit. Automation solutions are available for low, medium and high throughput settings.

Phill Keefe, Senior Vice President Product Design, Development and Delivery at Oxford Immunotec said, โ€œNot everyone with COVID-19 infection has detectable antibodies in serology tests, and this may be a bigger problem in the majority who experience only mild or no symptoms. Also, it is not yet clear whether the presence of antibodies confers immunity. T cell responses develop before antibody generation and can independently provide protection, so studying T cells could give us new insights into immunity to COVID-19.โ€

Oxford Immunotec CEO, Peter Wrighton-Smith commented, โ€œWe are really excited about the release of this RUO T-SPOT Discovery product in such an important area for current research. This allows us to make our contribution to the battle against COVID-19. The data generated using this RUO kit, if favourable, will help us develop a T-SPOT kit which could be approved for clinical use and may help support our return to a more normal lifestyleโ€.

Oxford Immunotec is committed to supporting the global efforts to stop TB and fight the COVID-19 pandemic. We are proud to sponsor The International Union Against Tuberculosis webinar, โ€œHow to Prevent 1.4 Million Deaths: Advancing TB Care and Prevention in the Time of COVID-19.โ€ Registration for the webinar, which is being held on Wednesday, 20 May at 16:00 CEST, and more information is available here https://join.theunion.org/205webinar.

About Oxford Immunotec

Oxford Immunotec Global PLC is a global, high-growth diagnostics company. We bring energy and invention to a world in need of diagnostic truth. Our leading product, the T-SPOT.TB test, is used for diagnosing infection with Tuberculosis, the worldโ€™s largest cause of death from infectious disease.

The T-SPOT.TB test has been approved for sale in over 60 countries, including the United States, where it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company is headquartered near Oxford, U.K. and in Marlborough, MA. T-SPOT, the Oxford Immunotec logo, T-Cell Select and T-SPOT Discovery are trademarks of Oxford Immunotec Limited.

 

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