The Hospital will use SOPHiA DDM to enhance its testing and research of blood cancers

SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a leader in data-driven medicine, today announced that Kepler Uniklinikum, Austria’s second largest hospital, is live on SOPHiA GENETICS’ platform. The hospital will use the SOPHiA DDM Platform to advance its next-generation sequencing (NGS) testing and diagnostics of blood-related cancers.

Kepler Uniklinikum, which has 1,800 beds, is the central healthcare provider for Upper Austria. The hospital will implement the SOPHiA DDM Platform across its medical and chemical laboratory locations to deepen its in-house NGS testing capabilities and expand its offerings to its patients, specifically for those faced with blood cancers and disorders.

Cancer is the second most common cause of death in Austria, with about 42,000 people diagnosed with cancer each year.¹ Additionally, on a global scale, blood cancers are the fifth most common type of cancer in the world.² Advances in diagnostics and treatment of blood cancers depend on timely, cost-effective, and reliable sequencing data. The SOPHiA DDM Platform uses NGS to target key variants from FFPE, blood, or bone marrow samples, helping lead to fast and accurate detection of variants associated with the disease. The SOPHiA DDM Platform is specifically designed to compute a wide array of genomic variants and continually hones its machine learning algorithms to detect genomic variants associated with rare and challenging cases.

“Kepler Uniklinikum’s implementation of the SOPHiA DDM Platform will help progress the use of data-driven medicine throughout Austria by ensuring their patients receive the most advanced and accurate testing,” said Kevin Puylaert, Managing Director, EMEA, SOPHiA GENETICS. “This testing will not only help the local population but will provide valuable insights and data to support others using the SOPHiA DDM Platform around the world.”

The SOPHiA DDM Platform delivers results that are nearly 100 percent reproducible to provide consistent inter- and intra-run results, ensuring stable and trustworthy sequencing data.

For more information on SOPHiA GENETICS, visit SOPHiAGENETICS.COM, or connect on LinkedIn. 

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The Agilent 7010D Triple Quadrupole GC/MS System (7010D GC/TQ) features the new HES 2.0 ion source, providing attogram-level sensitivity, unmatched robustness, and industry-leading uptime. Built-in intelligence, including SWARM autotune and Early Maintenance Feedback (EMF), streamlines analytical workflows and reduces unplanned instrument downtime, making it a reliable partner in navigating evolving regulatory requirements.

The 7010D GC/TQ also includes the My Green Lab Accountability, Consistency, and Transparency (ACT) Label, reflecting environmentally conscious manufacturing practices. Additionally, the MassHunter Acquisition 13.0 software enhances user experience with a refreshed interface and compliance tools, enabling users to take control of data integrity and adhere to compliance guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP5.

The Agilent ExD Cell available for the 6545XT AdvanceBio LC/Q-TOF enhances peptide and protein characterization capabilities by adding electron capture dissociation (ECD). With the trend towards increasingly complex biotherapeutics this meets the need for more thorough structural characterization.

The field installable ExD cell addon for the 6545XT is designed for researchers in the ‘discovery phase’ who are faced with diverse analytical challenges. ECD is particularly appropriate for the study of large proteins, fragile modifications, and isomeric residues – analytes which can be difficult to unambiguously characterize with traditional collision induced dissociation (CID) methods alone.

Coupled with the inherent capabilities of the 6545XT for intact protein analyses, the ExD cell is also suited for performing top to middle down characterization of large and highly charged proteins (such as antibodies) and smaller subunits (such as peptides), and the rich spectra produced can be interpreted with confidence using the ExDViewer.

“Intelligence capabilities are seamlessly integrated into instruments like the 7010D GC/TQ, recognizing the fiercely competitive landscape that is constantly evolving. Additionally, the Agilent ExD cell, in conjunction with the 6545XT AdvanceBio LC/Q-TOF, empowers scientists to meticulously scrutinize and more effectively characterize peptides—critical components in modern research and therapeutics,” stated Ken Suzuki, vice president and general manager of Agilent’s Mass Spectrometry Division.

“These cutting-edge products exemplify customer-driven innovation and excellence. By listening to our customers, we gain valuable insights into their challenges. We then channel this understanding into consistent innovation, resulting in outstanding products that precisely meet their needs,” added Suzuki.

Agilent is a leading solution provider of proven, robust, and reliable mass spectrometry technologies to a range of segments and a wide array of applications in the bio/pharma, life science research, food, and environmental markets. These new technological capabilities enable Agilent’s customers to increase data quality and interpretation while reducing the time and human attention required—more easily adapting to ever-changing market needs.

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EGFR is a biomarker that presents in some patients with NSCLC and that has specific targeted therapies associated with it. Currently, ~30-40% of eligible NSCLC patients do not receive appropriate testing¹. In September 2023, Tempus and AstraZeneca initiated a pilot program to leverage Next to identify this specific care gap at participating provider sites, using AI to scan unstructured clinical data to understand which patients may be eligible for testing based on clinical guidelines, and notifying treating physicians to inform care. The pilot’s initial success within the first six months prompted a new expansion of the program to support deployment of the care pathway model in a total of 15 provider sites.

“Next was designed to ensure all patients have access to treatment plans based on the most up-to-date guidelines by equipping physicians with cutting-edge tools in their existing workflows to support the delivery of evidence-based care,” said Chris Scotto DiVetta, Senior Vice President, AI Applications at Tempus. “We were excited to see initial success in this program and look forward to contributing to a future where advanced technology and medical expertise unite to improve outcomes for all patients.”

Tempus Next is designed to accelerate the adoption of precision medicine and enhance patient outcomes. The solution integrates seamlessly with EMRs in order to analyze a comprehensive suite of data—including clinical notes, molecular information, and imaging—to pinpoint certain deviations from care guidelines. Participating health systems receive regular updates, supporting guideline-directed care for their patients. To learn more, visit tempus.com/oncology/care-pathway-solution.

¹ Sadik H, Pritchard D, Keeling DM, et al. Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non-Small-Cell Lung Cancer. JCO Precis Oncol. 2022;6:e2200246. doi:10.1200/PO.22.00246

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To further the fight against global lung cancer, Qure.ai, a world leader in healthcare Artificial Intelligence (AI), will unveil its AI-powered lung cancer continuum at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, from May 31 to June 4, 2024.

Featuring AI solutions to identify, measure, manage, and monitor the end-to-end care, continuum is designed to support clinicians and advance developments for lung health in the pharmaceutical and medical device industries.

“Lung cancer is the leading cause of cancer-deaths worldwide, with approximately 75% of patients detected in late-stage disease. Earlier detection reduces the need for therapeutic or surgical intervention and boosts survival rates, by over 90% if treatment starts at stage 1,” states Prashant Warier, CEO and Co-founder of Qure.ai.

“Artificial intelligence for lung cancer powers early detection—not just as part of existing screening programs, but by finding small pulmonary nodules, often opportunistically, during general healthcare imaging procedures. This enables earlier identification and referral for imaging or treatment pathways. It also helps overcome the ongoing challenges of low lung cancer screening appointment uptake rates,” Prashant Warier adds.

The Qure.ai lung cancer continuum provides regulatory-cleared* individual or end-to-end detection, analysis, and monitoring tools, putting improved patient care at the heart of innovation:

• AI to identify missed lung nodules from chest X-rays and support in early lung cancer diagnosis;
• AI to measure lung nodules via CT scans and track volumetric growth as part of progression monitoring;
• AI to manage lung cancer cases via multi-modality reporting, collaboration and prioritization tools;
• AI to monitor drug efficacy and disease progression in clinical trials and cancer care research.

Qure.ai has extensive real-world experience with AI deployments at over 2700 sites in more than 90 countries. It is widely trusted by global institutions with partnerships, commercial deployments and research studies underway with AstraZeneca, the UK’s National Health Service (NHS) hospitals and major teleradiology companies in UK and US. Qure.ai is headquartered in Mumbai with regional team offices in New York and London.

*Global clearances such as FDA and EU MDR CE vary across geographies.

Contact:
Georgina Wright
georgina.wright@qure.ai

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SmartLinQ 

• ASCO Certified is a new certification program announced by ASCO in October 2023. Current ASCO Certified measures are now available within SmartLinQ.
• RxLinQ is a precision medicine feature in SmartLinQ that identifies patients who are potentially eligible for newly approved, molecularly targeted therapies using advanced methods that go “beyond the biomarker.”
• TriaLinQ is a SmartLinQ feature designed to simplify and reduce the burden on clinical trial staff through practice-optimized workflows, which can increase patient matching to complex clinical trial enrollment criteria through intelligent screening.

“The pace of progress in oncology is breathtaking,” said Louis Culot, General Manager of CancerLinQ. “Supporting a diverse of oncology care providers across new drug approvals, new diagnostic modalities and alternative clinical research options  – requires a learning network approach founded on clinical AI and advanced clinical informatics. At CancerLinQ, we are privileged to be working with leading oncology centers at the forefront of these innovations.”

CancerLinQ, founded by the American Society of Clinical Oncology (ASCO^®), became a ConcertAI initiative late in 2023. As part of this transition, ASCO and CancerLinQ formed a long-term cooperation agreement and commitment to continue providing quality solutions and SaaS technologies for the oncology community.

RxLinQ

CancerLinQ is introducing RxLinQ, a precision medicine enabler of SmartLinQ, identifies patients who are potentially eligible for newly approved therapies.

Benefits include:

• Reduces administrative burden of monitoring each patient to determine eligibility for new therapies 
  
• Improves outcomes by using a “Partial Match” list to indicate patients who could be eligible for a genomic test and targeted therapy
  
• Improves population health by matching to both established and newly seen patients
  
• Automates the monitoring and notification of new approvals, allowing teams to focus on other priorities 

TriaLinQ

TriaLinQ provides patient-to-trial matching within the SmartLinQ solution.  TriaLinQ streamlines the screening, study eligibility confirmation, and enrollment processes. The solution supports investigator initiated and industry sponsored trials, automates manual tasks, enhances precision of individual patient eligibility reviews, and ensure diverse patient inclusion.

Benefits include:

• A goal to increase the yield and matching of patients to trials, especially complex trials, based on automated data workflows
• Increase in patient treatment options by expanding access to clinical trials
• Minimization of labor-intensive manual pre-screening tasks to identify eligible patients

ASCO Certification

In October 2023, ASCO announced ASCO Certified, a new set of quality measures and tools that build on ASCO’s long-standing Quality Oncology Practice Initiative (QOPI^®). CancerLinQ has provided automated solutions for QOPI Certification and now, under the ASCO-CancerLinQ agreement, will develop and deploy ASCO Certified solutions. ASCO Certified not only represents a comprehensive set of measures that incorporate the latest clinical treatment quality guidance, but it is also designed to enable patient-centered practice transformation that aligns with the oncology medical home standards co-developed by ASCO and the Community Oncology Alliance (COA) in 2021. In addition, for practices employing Elsevier ClinicalPath, CancerLinQ and Elsevier have agreed to streamline the reporting and submission process, facilitating both quality measures and required pathways metrics.

Learn more about all these new initiatives at the CancerLinQ booth (#14013) at the 2024 ASCO Annual Meeting or visit cancerlinq.org.

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SK Telecom (NYSE:SKM, “SKT”) today announced that it officially launched its AI-based veterinary X-ray image diagnosis assistance service ‘X Caliber’ in Australia.

X Caliber is an innovative service that uses AI to analyze X-ray images of dogs/cats within around 15 seconds. Since X Caliber uses cloud to store and retrieve data, there is no need to install a separate server within the hospital. Veterinarians can examine the results of the AI-based image diagnosis on their mobile devices or PCs anywhere, anytime. The sensitivity of X Caliber stands at 86-94%: 94% for detection of 16 different abnormal patterns from abdominal X-ray images of dogs; 88% for detection of 10 different abnormal patterns from chest X-ray images of dogs; and 86% for detection of 7 different abnormalities from musculoskeletal X-ray images of dogs.

Since entering a strategic partnership with ATX Medical Solutions (“ATX”), a leading provider of medical devices in Australia, in November 2023, SKT has been working closely with ATX to prepare for the commercial launch of the service by running beta tests. With today’s official launch, X Caliber can be used by over 100 veterinary clinics in Australia.

Australia is a pet-loving country with one of the world’s highest pet ownership rates. Over two thirds of households are estimated to own a pet, with the total number of pets standing at around 29 million as of January 2024. The average number of pets per household in Australia is 1.3 dogs and 1.6 cats.

SKT and ATX will also be attending the Australian Veterinary Association (AVA) Conference 2024, one of the largest gatherings of veterinary professionals in Australia, in Melbourne from May 27-31, to introduce X Caliber to veterinarians.

Moreover, SKT announced that it signed a commercial contract with MEDIVET Pet Hospital & Clinic, Indonesia’s largest premium veterinary hospital chain, to provide X Caliber to MEDIVET’s hospital. The company sees this deal as a good opportunity to introduce X Caliber not only to Indonesia, but also to the rest of the Southeast Asian market.

Meanwhile, SKT is currently actively providing beta service to veterinary clinics in North America, Europe, and Asia to further expand X Caliber’s presence in the global market.

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iPredict Stroke and heart attack prediction models provide AI-based automated prediction scores for incident stroke and heart attack (i.e., myocardial infarction (MI)) which identifies the individuals who are at risk of having stroke and MI within 5 years. These results were peer-reviewed and accepted by the scientific review team and will be presented at the ESC Congress which will be held between 30^th August and 2^nd September 2024. The iPredict stroke and MI prediction models aim to help prevent strokes and heart attacks, saving millions of people from deaths or disabilities.

Using the high-resolution retinal color images of the individual’s eyes and health data, the iPredict AI System’s stroke and MI prediction results will be available in fully automated reports in less than 60 seconds. The entire test can easily and reliably be completed within 5 minutes.

For the identification of individuals who will suffer a stroke or heart attack in 5-year, the prediction models offer an overall accuracy of

• incident stroke with a sensitivity of 82.73%, specificity of 87.35%, and accuracy of 85.22%.
• incident MI with a sensitivity of 84.76%, specificity of 84.67%, and accuracy of 84.71%.

iPredict achieved higher accuracy than existing stroke and heart attack prediction models such as Framingham and Chads scores/CHADS2VASC scores.

iPredict’s stroke and MI models can be used to alert physicians of the need to take further preventive measures for these patients in the primary care settings.

The company also has AI-based screening tools for early diagnosis of diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucoma which are CE certified (i.e., cleared for the European market), MHRA/UK Health, TGA/Australian and UAE health approved.

iHealthScreen company is open to partnerships for collaboration and/or co-development of its products in various territories. For more information: https://www.iHealthScreen.org

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When asked about the collaboration, Anthony Morrison, MaximBio’s Chief Commercial Officer, said, “Their dedication to provide the best products with personal, efficient service makes them an ideal partner for MaximBio as we team up to help meet the growing demand for COVID-19 testing.” Michael Brown, Senior VP, Clinical Diagnostics at Thomas Scientific, agreed, “For over a century, Thomas Scientific has been committed to offering quality laboratory products while catering to the unique needs of the individual customer.  We are excited to add MaximBio’s innovative test to our product offering.” 

The ClearDetect^TM COVID-19 Antigen Home Test employs proven Lateral Flow Assay (LFA) technology with a simplified workflow that can easily be done at home without the need for equipment or a reader. The test’s unique format involves only 3 components—a swab, a test strip, and a test tube pre-filled with sample buffer. This eliminates reagent measuring or the need to handle dropper bottles as required with other card-based and self-test systems.

When compared to an EUA authorized PCR method, the MaximBio ClearDetect^TM COVID-19 Antigen Home Test performed well, achieving 86.9% Positive Agreement (PPA) and 98.9% Negative Agreement (NPA), making it one of the more sensitive and specific antigen tests available. The test also performed admirably when evaluated by the NIH with specimens positive for the Omicron variant, detecting 100% of live virus Omicron samples diluted to a PCR Ct value of 25.8. In the same study the assay detected the Omicron variant at a higher dilution than two other EUA-approved antigen tests.

The test will be available in two kit configurations—packaged two (2) tests in a box for convenient at-home use, and in a bulk 25-test pack amenable for healthcare settings, schools, workplaces, and other high-volume testing scenarios. Thomas Scientific will market both configurations and plans to price them competitively. MaximBio is currently ramping up production to meet the demand for COVID-19 testing and Thomas Scientific’s desire to fulfil customer needs.  

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MYND LIFE SCIENCES INC. (“MYND” or the “Company”) (CSE: MYND) (OTC: MYNDF) is pleased to announce its wholly-owned subsidiary MYND DIAGNOSTICS INC. (“MYND Diagnostics“) has commenced clinical research on a testing procedure for diagnosing and monitoring Alzheimer’s Disease (“AD“) utilizing the Company’s proprietary anti-inflammatory peptide (“MAP“) biomarker.

“Our research team has begun to research and explore the potential application of our proprietary MAP biomarker for use in the identification of Alzheimers disease”, stated Dr. Lyle Oberg, CEO of MYND. “The ability to make an early, accurate, dependable diagnosis in Alzheimer’s Disease patients thereby allowing for earlier intervention is a huge step forward in the fight against this terrible disease. We are extremely excited that the MAP biomarker has the potential to bridge that gap. The Company’s ultimate goal specific to diagnostics is to provide a cost-effective, easy to use diagnostic test kit that can be administered from anywhere with a dried blood spot. Helping families and health care practitioners with an effective tool for early diagnosis, monitoring and treatment for the millions impacted by this disease will be a significant innovation in central nervous system medicine”.

MYND Diagnostics will be initiating a clinical validation of the MAP biomarker in AD by collecting known blood samples of AD and quantifying the presence of MAP against control samples. This validation is planned to start in first quarter 2022.  Pending those results, the Company anticipates that a submission for FDA approval could take place as early as second half 2022 to prepare for commercialization and making the MAP Biomarker available to the public through healthcare practitioners. The Company’s goal is to develop diagnostic test to monitor and potentially diagnose inflammatory diseases of the central nervous system such as Alzheimer’s Disease. The Company’s diagnostic test is intended to give health care providers an objective monitoring tool to improve patient outcomes by providing more tailored and efficacious treatments.

Approximately 44 million people worldwide live with AD or a related form of dementia.¹  It is the sixth-leading cause of death in the U.S., killing more people than breast cancer and prostate cancer combined.² Only approximately one in four people with the disease get diagnosed.³ Further, the Alzheimer’s disease diagnostics and therapeutics market was valued at USD 6.6 billion in 2020, and it is expected to reach approximately USD 9 billion in 2026, registering a CAGR of nearly 5.36% during the forecast period, 2021-2026.⁴

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Medivolve Inc. (“Medivolve” or the “Company“) (NEO: MEDV)(OTC: COPRF)(FRA: 4NC), a healthcare technology company that seeks to reinvent the US healthcare system by leveraging a bespoke telehealth platform, clinical diagnostic network, and data driven AI to improve patient care, today announced financial results for the third quarter ended September 30, 2021.

“Medivolve delivered a quarter of strong results, achieving an impressive 575% increase in revenue growth compared to Q2,” said David Preiner, CEO of Medivolve. “We’re incredibly proud to see our testing services grow and exceed expectations. From here on out, everything we do is focused on furthering our mission and pushing the boundaries of what’s possible – not just for our company and shareholders, but also for physicians and patients, and for the future of healthcare.”

Q3 Financial Highlights 

• Revenue was $25.3 million in the third quarter of 2021, up 575%, compared to $3.7 million over the prior three-month period ending June 30, 2021.
• Gross profit was $10.5 million in the third quarter of 2021, up 1,288%, compared to $753,535 over the prior three-month period ending June 30, 2021.
• Net income was $6.8 million in the third quarter of 2021, compared to a net loss of $8.7 million over the prior three-month period ending June 30, 2021.
• Cash on balance sheet of $0.9 million and $1.9 million of debt at the end of third quarter 2021

Q3 Developments and Business Highlights

• Closed $12 million in funding needed to consolidate legacy debt and strengthen the Company’s balance sheet
• Transitioned from a cash pay business model to Insurance Reimbursements increasing daily gross revenue and revenue per patient compared to the legacy cash-based business model used since the Company’s inception
• Boosted testing services revenue by automating claim submissions to over 8,700 insurance carriers; this, combined with access to respective government programs for the uninsured and undocumented, the Company estimates a population coverage of over 99.7% of individuals could be eligible for COVID-19 testing at no cost to patients.
• Launched plans and began the hiring process to build network of medical professionals including doctors, physician assistants, registered nurses, nurse practitioners, and therapists to expand the Company’s clinical diagnostic network
• Finalized acquisition of CalVax licensed Marbella Pharmacy, an open-door pharmacy, providing the ability to deliver patient care through immediate access to pharmaceutical distribution throughout the state of California
• Launched initiative and began hiring software engineers and developers to sustain the Company’s rapid growth rate, while developing additional successful applications
• Released Medivolve 2.0, a HIPAA-compliant patient portal that introduced new opportunities to support the Company’s change in COVID-19 testing operations
• Expanded nationwide B2B employee programs bringing on-site COVID-19 testing services to schools, workplaces, and events
• Closed $1.2 million Convertible Note Financing to support strategic plan including next phase of growth for AI technology platform

Q4 Outlook

The recent surge of COVID-19 cases across America continues, strengthen Medivolve’s case for more frequent testing. Organizations nationwide, including government officials, are requiring employees to be vaccinated, and submit to routine testing.

Infectious disease experts are predicting another spike of COVID-19 cases during and after upcoming holiday season. Medivolve’s medical directors also say cases could simply increase as people move indoors during the cold winter months.

“As the number of cases of COVID-19 rise, it’s the latest sign that regular testing will continue to emerge as a potential fallback for organizations to retain employees without full vaccination coverage,” shared David Preiner. “Everywhere from workplaces to schools, to concert or large event venues, people are being asked to show proof that they are not infected; therefore, testing remains a critical part of our business model.”

Upcoming Analyst & Investor Webinar

Medivolve will host a live webinar with analysts and investors on Tuesday, November 30, at 2:00pm Eastern Time.

The webinar can be accessed by registering online, at which time registrants will receive a calendar invite with a link and dial-in information.

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