NTRA stock rose on September 25, 2020, after the price target was raised to $82 from $66 at Craig-Hallum.
Craig-Hallum analyst Alexander Nowak raised the firm’s price target on Natera to $82 from $66 and keeps a Buy rating on the shares. Yesterday, Medicare issued a draft LCD effectively endorsing Signatera as a pan-cancer recurrence monitoring test, which Nowak says was spawned out of Natera’s second cancer submission. The analyst says the new policy draft has important implications for the third, fourth and fifth cancer indications, as the draft policy streamlines reimbursement, and views it as a major win and another element that solidifies Natera’s pole position in cancer.
On September 24, 2020, Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, announced that the CMS Molecular Diagnostics Program (MOLDX) has issued a draft local coverage determination (LCD) to provide expanded coverage for circulating tumor DNA (ctDNA) tests that detect MRD in patients with a history of cancer. In particular, the proposed expansion would cover the Signatera MRD test for immunotherapy response monitoring. The LCD is posted here on the Centers for Medicare and Medicaid Services website.
The proposed LCD follows Medicare’s recent final coverage decision in colorectal cancer released earlier this month. In its description of the IO monitoring indication, the draft LCD specifically references Signatera and the pan-cancer validation study recently published in Nature Cancer. In that study, Signatera identified treatment non-responders with a 100% positive predictive value, when used in conjunction with imaging.
In addition, the draft LCD creates a pathway for coverage of Signatera in additional solid tumor types and indications, where it is clinically validated with peer-reviewed evidence and where the clinical utility is established. Signatera has been validated across multiple cancer types to detect residual disease up to 2 years earlier than standard diagnostic tools.
“Medicare’s proposed coverage offers enormous benefit to the over 200,000 patients being treated with immune checkpoint inhibitors,” said Solomon Moshkevich, General Manager of Oncology at Natera. “We look forward to working with the oncology community to generate further evidence supporting the clinical value of Signatera in both early-stage and advanced-stage cancers.”
Piper Sandler analyst Steven Mah raised the firm’s price target on Natera to $76 from $63 and keeps an Overweight rating on the shares. The stock in afternoon trading is up 5% to $65.34. Palmetto today made a “shocking move” by issuing a draft local coverage determination for “Minimal Residual Disease Testing for Cancer,” implying its MolDx program will cover minimal residual disease tests for any cancer if comparable or better to Signatera, Piper Jaffray analyst Steven Mah tells investors in a research note. The news “substantially moves up the timing” of additional cancer indications and “greatly de-risks” reimbursement, says Mah. The analyst notes that Natera has Signatera data in 13 indications and planned to pursue Centers for Medicare and Medicaid Services approval for one indication per year. Mah views Palmetto’s move as a “massive win” for Natera’s oncology business.