CareDx says Medicare proposes to maintain reimbursement process for AlloMap » 07:2210/1910/19/20
CareDx announced that…
CareDx announced that the Centers for Medicare and Medicaid Services recently issued a memo recommending continued coverage of AlloMap through local Medicare Administrative Contractors. AlloMap is widely adopted by physician providers in over 90% of transplant centers across the US, has been the standard of care and incorporated into guidelines by the International Society for Heart and Lung Transplantation since 2010, and is covered by a CPT code which is reimbursed by Noridian, the local MAC in California. The recently issued CMS memo was in response to a request made by a pathologist in January 2013 to make a national coverage determination to non-cover AlloMap. The CMS memo acknowledges that since 2013 there have been multiple studies that have demonstrated the clinical utility of AlloMap, and concludes that continuing the current AlloMap reimbursement process by MACs is clinically appropriate and in the best interests of beneficiaries.
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Fly Intel: Wall Street's top stories at midday » 12:1610/0810/08/20
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Stocks are mildly higher…
CareDx price target raised to $55 from $45 at BTIG » 08:2210/0810/08/20
BTIG analyst Sung Ji Nam…
BTIG analyst Sung Ji Nam raised the firm's price target on CareDx to $55 from $45 and keeps a Buy rating on the shares after the company's "impressive" Q3 revenue pre-announcement. The analyst notes "strong performance" across the board in CareDX business, with Testing revenue up 60%, product revenue up 29%, and Digital/Other revenue up 73% from last year. Sung Ji Nam adds that patient access has recovered "significanty" since Q2 while stating that CareDX still has "significant headroom" for strong growth ahead.
CareDx price target raised to $66 from $46 at Craig-Hallum » 07:3810/0810/08/20
Craig-Hallum analyst Alexander Nowak raised the firm's price target on CareDx to $66 from $46 and keeps a Buy rating on the shares. The analyst notes that CareDx reported preliminary Q3 revenue and test volume well ahead of consensus as "past year/quarter(s) investments are paying off." The performance was clean and Nowak expects sequential growth going into Q4 too.
CareDx price target raised to $47 from $45 at H.C. Wainwright » 06:2110/0810/08/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Yi Chen raised the firm's price target on CareDx to $47 from $45 and reiterates a Buy rating on the shares. The company reported "robust" sequential growth in Q3, Chen tells investors in a research note.
CareDx price target raised to $62 from $54 at Piper Sandler » 05:1610/0810/08/20
Piper Sandler analyst…
Piper Sandler analyst Steven Mah raised the firm's price target on CareDx to $62 from $54 and keeps an Overweight rating on the shares after the company reported Q3 preliminary revenue. AlloSure and AlloMap volume for the quarter was 21,800, significantly above the analyst's estimate of 17,737, driven by use of AlloSure in more transplant centers and an increasing number of patients being put on an AlloSure protocol. Mah expects that CareDx's investments into patient care management and digital health solutions will continue to drive organic growth in the future.
Fly Intel: After-Hours Movers » 19:1510/0710/07/20
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CareDx up over 15% at $50.50 per share after guiding Q3 revenue above consensus 17:2110/0710/07/20
CareDx sees Q3 revenue $53M, consensus $44.68M » 16:1010/0710/07/20
Preliminary revenue for…
Preliminary revenue for the three months ended September 30 is expected to be approximately $53M, an increase of 57% compared with $33.8M in the third quarter of 2019. Testing revenue for the quarter is expected to be approximately $45.2M, compared with $28.2M in the same period in 2019. Total AlloSure and AlloMap patient results provided in the quarter were approximately 21,800. Product revenue in the three months ended September 30, 2020 is expected to be $5.4 million, compared to $4.2M in the same period in 2019. Digital & other revenue in the third quarter of 2020 is expected to be $2.4 million, compared to $1.4 million in the same period in 2019. The preliminary information presented in this press release is based on CareDx's current expectations and may be adjusted as a result of, among other things, completion of customary quarterly review procedures."We continue to invest in growth initiatives to position CareDx as the leader in transplantation and expand our pipeline, including most recently with patient care management and digital solutions," said Reg Seeto, President and Chief Business Officer. "As a result of our strategic investments, we have been able to adapt more efficiently to meet the needs of individual transplant centers during this pandemic and to attract incredible talent to join the CareDx team."
CareDx announces publication of AlloSure lung data » 07:0610/0210/02/20
CareDx announced the…
CareDx announced the publication of pivotal clinical data for AlloSure Lung in Transplantation Direct and in Biomarker Insights. Transplantation Direct published AlloSure Lung data from the international, multi-center Lung Allograft Rejection Gene expression Observational Study. This study demonstrated that AlloSure Lung could identify patients with acute cellular rejection, a critical need for lung transplant patients whose only option to detect rejection is an invasive bronchoscopy. CareDx has offered AlloSure for lung transplant patients under compassionate use since February 2019 and in June 2020 submitted its AlloSure Lung dossier to Palmetto MolDx for Medicare reimbursement. In the LARGO study, AlloSure Lung results had concurrent lung histopathology that had been assessed by a blinded consensus of an expert pulmonary pathologist panel. A total of 69 unique lung transplant patients from nine centers were examined and included histopathologic diagnoses of allograft infection, normal histopathology without infection, and ACR. The authors concluded that AlloSure Lung holds promise as a non-invasive biomarker of allograft injury with ACR in lung transplant patients. The University of Texas San Antonio experience with AlloSure Lung was published in Biomarker Insights. This publication shared data from a group of 48 patients, in five different cohorts. The patients analyzed varied between three months and 12 years after lung transplantation. The letter from Drs. Deborah Levine, David Ross and Edward Sako supported the concept that further investigation and serial trend monitoring with AlloSure may serve valuable for assessment of lung transplantation allograft dysfunction and to preserve allograft health. These investigators emphasized the value of non-invasive testing with AlloSure Lung is especially high during the COVID-19 pandemic.