Kantaro receives FDA EUA for semi-quantitative COVID-19 antibody test kit » 07:3211/2511/25/20
Kantaro Biosciences, a…
Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI (RNLX), has received Emergency Use Authorization from the U.S. FDA for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit. Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in the fight against COVID-19. Through a commercial partnership with Bio-Techne (TECH) the test kits are being manufactured at scale with a capacity of up to 10M tests per month and the ability to scale up.
Renalytix AI reports Q1 EPS (10c) vs. (3c) last year » 07:1411/2511/25/20
Cash, cash equivalents…
Cash, cash equivalents and short-term investments of $82.3M as of September 30, 2020. This includes $76.1M from the Company's initial public offering on the Nasdaq Global Market after commissions, fees and offering expenses.
|Over a week ago|
Renalytix AI appoints Investec Bank as joint corporate broker » 07:2611/0611/06/20
Renalytix AI announces…
Renalytix AI announces the appointment of Investec Bank plc as joint corporate broker, with immediate effect to work alongside its existing nominated adviser and joint broker, Stifel.
|Over a month ago|
Bio-Techne and Renalytix's Kantaro JV to market COVID-19 testing in UK, Europe » 07:4410/2810/28/20
Kantaro Biosciences, a…
Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI (RNLX), and manufacturing partner Bio-Techne (TECH), entered into a two-year marketing and distribution agreement with EKF Diagnostics. EKF will offer COVID-SeroKlir, Kantaro's quantitative SARS-CoV-2 IgG antibody test kit, in Europe with exclusive rights in the UK and Germany and COVID-SeroIndex, for the European research market, on a non-exclusive basis. Kantaro quantitative antibody testing technology supports the assessment of immunity to COVID-19. The agreement follows the receipt of the CE Mark certification approving the use of both COVID-SeroKlir and COVID-SeroIndex for detecting the presence and the precise titer of IgG antibodies. COVID-SeroKlir and COVID-SeroIndex have demonstrated 97.8% sensitivity and 99.6% specificity for detecting COVID-19 specific IgG antibodies.
Kantaro, Bio-Techne: CE Mark granted to SARS-CoV-2 IgG antibody test kits » 07:3910/2610/26/20
Kantaro Biosciences, a…
Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI (RNLX), and partner Bio-Techne (TECH) have received CE marking for COVID-SeroKlir and COVID-SeroIndex, Kantaro's quantitative SARS-CoV-2 IgG antibody test kits. Both kits are available immediately and can be used by any authorized clinical testing laboratory in the European Union without the need for proprietary equipment. Approved as in vitro diagnostics, COVID-SeroKlir is configured to be most useful in a clinical setting, while the COVID-SeroIndex configuration is expected to be used for research purposes or vaccine development.
Renalytix AI receives California commercial laboratory certification » 07:0409/2209/22/20
Renalytix AI announced…
Renalytix AI announced that it has received a California Clinical Laboratory License from the California Department of Health for its clinical laboratory in Salt Lake City, Utah. KidneyIntelX may now be used to report risk assessment of progressive decline in kidney function for patients in California with early stage diabetic kidney disease. With this certification, the Company is now licensed to provide KidneyIntelX testing services for patients in 49 states. According to the American Society of Nephrology, California has more than five million patients with kidney diseases, 94,000 patients diagnosed with kidney failure and 68,000 patients on dialysis,1 one of the highest rates of CKD in the nation. In August 2020, RenalytixAI announced that it filed a submission seeking clearance of KidneyIntelX with the U.S. Food and Drug Administration. This FDA filing builds on the Company's regulatory and commercialization program, which includes the September 18th announcement of the commercial launch of the KidneyIntelX clinical test reporting platform within the Mount Sinai Health System. This launch follows the announcement that the New York State Department of Health issued a clinical laboratory permit for commercial clinical testing of KidneyIntelX in June 2020.
Renalytix AI announces commercial launch of KidneyIntelX test platform » 07:0709/1809/18/20
Renalytix AI announces…
Renalytix AI announces the commercial launch of the KidneyIntelX clinical test reporting platform within the Mount Sinai Health System in New York City. KidneyIntelX risk assessment of progressive decline in kidney function or kidney failure, including education support for treating clinicians, is now commercially available for patients with early stage diabetic kidney disease. In addition to patient testing and risk assessment, a central component of this launch milestone is the physician education and support program developed in close collaboration with leadership of the Mount Sinai Departments of Medicine and Population Health Science and Policy, with input from patient advocacy groups and the broader clinical community. This expert experience is reflected in the design of the KidneyIntelX test report and the newly launched product website - www.kidneyintelx.com. Agreements with Laboratory Corporation of America and a national medical logistics provider were entered into in calendar Q3 to support sample collection at five patient service centers servicing Mount Sinai patients. The Company intends to scale this process with laboratory service providers and logistics providers across multiple territories in the United States to ensure patient blood samples can be efficiently and securely delivered to RenalytixAI laboratories in New York, New York and Salt Lake City, Utah. In June 2020, the Company announced that it received a clinical laboratory permit from the New York State Department of Health to provide commercial testing of KidneyIntelX. The Company is currently licensed to provide testing services for patients in 48 states. With the commercial launch at Mount Sinai, RenalytixAI expects revenue generation to increase in the near-term.
|Over a quarter ago|
Renalytix AI files submission seeking FDA clearance of KidneyIntelX » 07:0408/2608/26/20
Renalytix AI announces…
Renalytix AI announces that it has filed a submission seeking clearance of KidneyIntelX with the U.S. Food and Drug Administration. This FDA filing builds on the Company's regulatory and commercialization program, which includes the June 12, 2020 announcement that the New York State Department of Health has issued a clinical laboratory permit for commercial clinical testing of KidneyIntelX. KidneyIntelX is designed to provide potentially critical new information to health care providers, insurance payors and population health managers in an effort to support optimization of care delivery, improve patient outcomes and reduce the $120B annual cost of chronic and end-stage kidney disease to the United States healthcare system. In May 2019, RenalytixAI announced that KidneyIntelX was granted Breakthrough Device designation by FDA, the first such designation for an artificial intelligence-enabled in vitro diagnostic for kidney disease publicly announced by any company. FDA clearance is now being sought for the intended use of KidneyIntelX, in conjunction with clinical evaluation, as an aid to further assess the risk of progressive decline in kidney function within a period of up to five years in patients over the age of 21 with type 2 diabetes and existing chronic kidney disease. Patients with CKD and type 2 diabetes account for 20-30 percent of the estimated 37 million U.S. patients with CKD2. Performance data provided by RenalytixAI in the FDA 510(k) submission is based on a multi-center validation study of more than 1,100 patients demonstrating that KidneyIntelX accurately identifies patients in early CKD stages 1, 2 and 3 who are at highest risk of progressive decline in kidney function and/or kidney failure.
Renalytix AI initiated with a Neutral at JPMorgan » 08:3908/1108/11/20
JPMorgan analyst Tycho…
JPMorgan analyst Tycho Peterson initiated coverage of Renalytix AI with a Neutral rating and $19 price target. While he said Renalytix AI's "first-in-class" KidneyIntelX diagnostic platform for fast-progressing chronic kidney disease has proven to have greater predictive power than existing tests, he sees the stock's valuation capping near-term upside and thinks further upside depends on a successful commercial scale-up.
Renalytix AI initiated with a Buy at Stifel » 07:2208/1108/11/20
Stifel analyst Daniel…
Stifel analyst Daniel Arias initiated coverage of Renalytix AI with a Buy rating and $22 price target. The KidneyIntelX test looks well-positioned for a successful product launch within a clinical opportunity that is both very large and very in need of prognostic solutions, Arias told investors in a research note. While he did acknowledge the risks of an early-stage asset, the analyst views the use case and revenue ramp as "attractive." Lastly, he noted the company fits the bill for investors looking for "emerging diagnostics players with transformational potential."