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Renalytix plc (NASDAQ: RNLX) is a pioneering company focused on the development of artificial intelligence (AI)-enabled clinical diagnostic solutions for kidney disease, one of the most widespread and costly chronic medical conditions worldwide. The company's flagship product, KidneyIntelX™, is designed to improve the diagnosis, prognosis, and clinical management of kidney diseases, particularly in patients with type II diabetes and those of African ancestry who are at risk of fast-progressing kidney disease. By leveraging advanced AI algorithms, KidneyIntelX aims to enhance patient stratification for drug clinical trials, facilitate drug target discovery, and ultimately reduce the estimated $114 billion annual cost of chronic and end-stage kidney disease to the U.S. healthcare system.
Renalytix plc has achieved significant milestones, including the commercial launch of KidneyIntelX as a laboratory-developed test in its CLIA-certified laboratory facilities. The company's diagnostic solutions are designed to be integrated into health systems and utilized by drug developers for better patient outcomes. Recently, KidneyIntelX received FDA De Novo authorization, marking a significant step towards widespread clinical adoption.
Recent Achievements:
- Inclusion of KidneyIntelX in clinical guidelines
- Issuance of a Medicare coverage draft
- Launch of a direct-to-physician sales force
- Release of new real-world outcomes evidence
- Significant year-over-year expense reductions
- Completion of equity financing
- Initiation of a strategic sale process
Renalytix plc has also formed strategic partnerships with prominent research institutions such as Mount Sinai, Wake Forest, and Joslin, to advance its research and development efforts. The company's financial strategy includes a plan to further reduce payroll expenses and total general and administrative costs while preserving its sales capacity.
With an unwavering commitment to innovation and patient care, Renalytix plc continues to lead the way in transforming kidney disease diagnosis and treatment, thereby creating substantial value for patients, healthcare providers, and investors alike.
Kantaro Biosciences, a joint venture with RenalytixAI and Bio-Techne, announced that the FDA has added its COVID-SeroKlir antibody test to the Emergency Use Authorization (EUA) for convalescent plasma treatment in hospitalized COVID-19 patients. The test, which detects SARS-CoV-2 IgG antibodies with 98.8% sensitivity and 99.6% specificity, aims to qualify high titer convalescent plasma. Kantaro emphasizes the test's potential role in advancing COVID-19 therapeutics, having been used nearly 90,000 times across diverse populations since its initial FDA authorization in November 2020.
Kantaro Biosciences has partnered with Atrys Health to market and distribute its COVID-SeroKlir and COVID-SeroIndex antibody tests in select European and South American regions, such as Spain, Portugal, and Brazil. These tests have achieved a CE Mark, demonstrating high sensitivity (97.8%) and specificity (99.6%) for SARS-CoV-2 IgG antibodies. This collaboration aims to enhance COVID-19 testing accessibility, critical for public health decisions and vaccine response analysis.
Renalytix AI (NASDAQ: RNLX) will co-host a Capital Markets Day for Kidney Health on February 11, 2021, with the American Society of Nephrology. This virtual event aims to gather stakeholders in kidney health, including leading clinicians and innovators, to discuss advancements in kidney disease management. The event highlights the urgent need for innovation in this public health crisis, which affects over 850 million people globally and incurs more than $120 billion annually in Medicare costs in the U.S. Key speakers include Susan E. Quaggin and James McCullough.
The National Kidney Foundation (NKF) has partnered with Renalytix AI (NASDAQ:RNLX) to enhance the diagnosis and assessment of early-stage kidney disease. This initiative aims to guide clinical interventions and improve patient outcomes, as roughly 90% of individuals with early kidney disease are unaware of their condition. NKF and RenalytixAI plan to undertake studies to examine current care standards and identify barriers to optimal treatment. The collaboration will leverage the KidneyIntelX diagnostic platform to categorize patient risk for disease progression and facilitate individualized care.
Kantaro Biosciences, a joint venture with RenalytixAI (NASDAQ: RNLX), has received Emergency Use Authorization from the FDA for its COVID-SeroKlir antibody test kit. This semi-quantitative test detects IgG antibodies, demonstrating 98.8% sensitivity and 99.6% specificity. Manufactured in partnership with Bio-Techne Corporation (NASDAQ: TECH), production can reach up to 10 million tests monthly. The test aids in healthcare decision-making and assessing vaccine responses, underlining its importance in the ongoing fight against COVID-19.
Kantaro Biosciences has formed a two-year marketing and distribution agreement with EKF Diagnostics to provide its COVID-19 antibody tests, COVID-SeroKlir and COVID-SeroIndex, across Europe, with exclusive rights in the UK and Germany. The tests boast a CE Mark certification, demonstrating high sensitivity (97.8%) and specificity (99.6%) in detecting IgG antibodies. This partnership aims to enhance public health strategies and assist in assessing immunity amidst ongoing vaccination efforts. The technology is based on extensive research at the Mount Sinai Health System.
Kantaro Biosciences, in partnership with Bio-Techne Corporation, has secured CE marking for its COVID-SeroKlir and COVID-SeroIndex antibody test kits. These quantitative tests, now available to authorized clinical labs in the EU, provide crucial data about COVID-19 antibody presence and levels. COVID-SeroKlir demonstrates 97.8% sensitivity and 99.6% specificity, supporting both clinical and research applications. Kantaro aims to produce up to 10 million tests monthly, enhancing pandemic response efforts.
Renalytix AI plc (NASDAQ: RNLX) announces it will report audited financial results for the year ending June 30, 2020, on October 27, 2020. An analyst conference call will be held at 8:30 a.m. EDT to discuss these results, featuring CEO James McCullough and CFO James Sterling. The company is focused on optimizing kidney disease clinical management using AI solutions, addressing a pressing public health issue, with over 850 million affected globally. RenalytixAI emphasizes the need for improved awareness and diagnosis of chronic kidney disease (CKD), often termed a 'silent killer.'
Renalytix AI (NASDAQ: RNLX) has received a Clinical Laboratory License from California for its Salt Lake City lab, enabling it to provide KidneyIntelX testing services in 49 states. The KidneyIntelX platform assesses the risk of kidney function decline in patients with early-stage diabetic kidney disease. With over five million Californians affected by kidney disease, this certification marks a crucial step in optimizing clinical management and improving patient outcomes. The company aims to reduce the $120 billion annual cost of chronic kidney disease in the U.S.
Renalytix AI (RNLX) has launched its KidneyIntelX clinical test platform at Mount Sinai Health System, New York. This platform targets early-stage diabetic kidney disease (DKD), providing risk assessment and educational support to clinicians. Strategic agreements with Laboratory Corporation of America enhance sample collection efforts. With recent licensing to operate in 48 states, RenalytixAI anticipates near-term revenue growth from this launch, aiming to improve kidney disease management and reduce healthcare costs associated with chronic kidney disease in the U.S.
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