Cue Health applies with FDA for EUA of its Cue Flu + COVID-19 molecular test » 09:2410/0410/04/22
Cue Health announced that…
Cue Health announced that on September 30, 2022, it submitted an application with the U.S. Food and Drug Administration, FDA, for Emergency Use Authorization, EUA, for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care, POC, use. The new Cue Flu + COVID-19 Molecular Test can simultaneously detect and differentiate between influenza and COVID-19 in approximately 25 minutes, with results delivered digitally to the Cue Health App on the user's mobile device. If authorized, Cue's Flu + COVID-19 test will be integrated into Cue Care, the company's same-day, test-to-treatment solution within the Cue Health App, which enables individuals to consult with a healthcare professional and get treatment delivered to their home within hours if medically indicated. "An accurate flu and COVID-19 test that can be done anywhere is a powerful tool. Combining this with the capability to treat on the same day enables a paradigm shift in respiratory diseases," said Ayub Khattak, Chairman and CEO of Cue Health. "We hope to enable this paradigm shift across the spectrum of infectious diseases and more with the many additional products in our pipeline."
Personalis enters gastroesophageal cancer research pact with Duke, Olink » 09:1310/0410/04/22
Personalis has joined…
Personalis has joined with Duke University and Olink Proteomics AB to form a research collaboration to study the effects of immunotherapy on advanced gastroesophageal cancer. Specifically, the collaboration will focus on identifying composite biomarkers-those that integrate multiple biological entities into a single readout-to help guide therapeutic decision making.
|Over a week ago|
Cue Health appoints Tsay as Chief Medical Officer » 09:1809/0809/08/22
Cue Health (HTLH)…
Cue Health (HTLH) announced that it has appointed David Tsay, MD, PhD, as its Chief Medical Officer. Dr. Tsay comes to Cue with more than 20 years of experience in clinical medicine, research, and health technology. Most recently, Dr. Tsay served at Apple (AAPL), where he led an Apple Health clinical team in developing new Health products.
|Over a month ago|
Cue Health makes de novo submission to FDA for flu molecular test clearance » 09:1809/0109/01/22
Cue Health has made a de…
Cue Health has made a de novo submission to the FDA for full clearance of the Cue Flu Molecular Test for at-home and point-of-care use. There are currently no flu tests on the market for home use. Clinical study results with the Cue Flu Molecular Test were favorable, demonstrating 99% accuracy compared to FDA cleared molecular laboratory tests for influenza A&B. Cue's molecular COVID-19 test, which is authorized by the FDA for home and POC use under an Emergency Use Authorization, is also currently under de novo review with the FDA.
Cue Health's POC COVID-19 test as accurate as lab-based PCR test in study » 16:1708/1708/17/22
Cue Health announced the…
Cue Health announced the preprint publication of an independent clinical study, the largest of its kind on asymptomatic people, demonstrating that its point of care molecular COVID-19 test, which produces results in approximately 20 minutes, is as accurate as a centralized lab-based RT-PCR. The study presents findings from a head-to-head comparison of the Cue COVID-19 test against lab-based RT-PCR on paired samples from 3,037 individuals. The findings revealed a 99.4% match between results from Cue's test and the reference PCR tests, including 100% clinical sensitivity to detect positive cases, yielding no false negatives. Of this testing population, 98.7% was asymptomatic at varying stages of infection and viral load.
Personalis files amended complaint against Foresight Diagnostics » 16:1608/1708/17/22
Personalis announced it…
Personalis announced it has filed an amended complaint against Foresight Diagnostics. The amended complaint asserts a newly-issued patent in Personalis' growing intellectual property portfolio relating to detection of molecular residual disease. The patent, US Patent No. 11,408,033, which issued on August 9, 2022, claims priority to one of Personalis' earliest patent families. It covers personalized MRD panels combining tumor-informed and database-derived content. This combination supports the detection, quantification, and characterization of a tumor over time, by sequencing circulating tumor DNA of the individual. On August 2, 2022, Personalis filed a complaint against Foresight for infringement of Personalis' U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394. These three patents are also part of Personalis' intellectual property portfolio in the field of whole genome-enabled, tumor-informed MRD testing. Personalis continues to seek both injunctive relief and monetary damages based upon Foresight's infringement. "The granting of the '033 patent provides further recognition of Personalis as a pioneer in the field of leveraging whole genome sequencing for clinical applications," said John West, CEO and co-founder of Personalis. "We stand firm in our resolve to protect our investment and leadership position in the field."
Lucid Diagnostics reports preliminary Q2 adjusted EPS (28c), consensus (33c) » 16:2808/1508/15/22
Reports preliminary Q2…
Reports preliminary Q2 revenue $0, consensus $640,000. Lucid had cash and cash equivalents of $32.7M as of June 30, 2022, compared to $53.7M as of December 31, 2021. "The past quarter and recent weeks have been a transformational period for Lucid, during which we have achieved key milestones which represent the final bricks in the foundation upon which we are building this company and driving its long-term growth strategy," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We now have a consensus among the major specialty societies which explicitly support the use of our products to prevent esophageal cancer deaths through early detection of esophageal precancer, and further expand our addressable market. And, for the first time, we are truly, from an operational perspective, an independent full-service medical diagnostic company capable of fulfilling the clinical and economic potential of these products."
Personalis announces collaboration with BC Cancer to deploy RUO assay » 09:0208/1508/15/22
Personalis announced a…
Personalis announced a collaboration with BC Cancer to deploy a personalized liquid biopsy-based research use only, or RUO, assay for a study of patients with colorectal and pancreatic cancers. The research efforts will deploy Personalis' NeXT Personal, which has demonstrated high sensitivity for detecting circulating tumor DNA, or ctDNA, from a patient's blood sample, to determine the best time to draw blood for ctDNA sampling for molecular residual disease, or MRD, detection. MRD describes a very small number of cancer cells that remain in the body during or after treatment.
Cue Health sees Q3 revenue $55M-$60M, consensus $54.6M 16:0308/1008/10/22
Cue Health reports Q2 EPS (37c), consensus (46c) » 16:0308/1008/10/22
Reports Q2 revenue…
Reports Q2 revenue $87.7M, consensus $52.9M. "We achieved stronger-than expected revenue performance in the quarter and continued to deliver on our pipeline programs," said Ayub Khattak, Chairman and CEO of Cue Health. "We are very excited about our upcoming full launch of Cue Care, closing the virtual health care loop by allowing customers to conduct a molecular diagnostic test, consult a medical professional, and get treatment delivered, all within the Cue Health platform. With the addition of e-prescription fulfillment and delivery to our product offerings, Cue has taken another important step forward on our mission to enable personalized, proactive and informed healthcare that empower people to live their healthiest lives."