Natera Inc Stock Price, News & Analysis

Natera (NASDAQ: NTRA) has received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) for its Signatera molecular residual disease (MRD) test. The initial reimbursement rate for each Signatera assay is set at $3,500. This test is instrumental in monitoring cancer recurrence, having shown efficacy up to two years prior to conventional imaging methods. With over 3,000 patients studied, Signatera has received three Breakthrough Device Designations from the FDA. Natera aims to expand access to this innovative testing technology.

Natera (NASDAQ: NTRA) announced a study published in Nature validating its Signatera ctDNA assay's ability to predict immunotherapy outcomes. This marks Signatera's 12th peer-reviewed publication and the first demonstrating the predictive capabilities of a molecular residual disease (MRD) test in a large randomized trial. Key findings included a 41% improvement in overall survival for ctDNA-positive patients treated with atezolizumab, compared to those under observation alone. The results suggest Signatera could enhance personalized cancer therapy and patient stratification.

Foundation Medicine and Natera, Inc. (NASDAQ: NTRA) have launched the research use version of FoundationOne Tracker, a personalized ctDNA monitoring assay. This innovative product combines Foundation Medicine's genomic profiling with Natera's ctDNA expertise, targeting both advanced and early-stage research applications. The partnership aims to streamline the workflow for including ctDNA monitoring results in retrospective studies, thereby enhancing drug development in oncology. Executives from both companies predict that this tool will help establish personalized ctDNA monitoring as a standard oncology care.

Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA testing, announced its participation in the American Transplant Congress (ATC) 2021 Virtual Connect from June 4-9. The company will present new scientific data on its Prospera test, which evaluates organ transplant rejection. Presentations include findings from leading physicians, emphasizing the importance of cfDNA in timely decision-making for nephrologists. The Prospera test enhances rejection assessment by measuring donor-derived cfDNA, having shown improved sensitivity in recent studies.

Natera, Inc. (NASDAQ: NTRA) announced it is being sued by Guardant Health, which aims to prevent the disclosure of Guardant Reveal's™ performance metrics. Natera claims Guardant's marketing includes misleading assertions about its molecular residual disease (MRD) test, covering sensitivity and specificity. Allegations include inflated sensitivity rates linked to inadequate clinical evidence and misrepresentations of test applicability to specific cancer stages. Natera seeks to ensure transparency in MRD testing to prioritize patient safety.

Natera, Inc. (NASDAQ: NTRA) announced new clinical data on its molecular residual disease (MRD) assay, Signatera, to be presented at the ASCO annual meeting from June 4-8, 2021. Highlights include four presentations focusing on multiple myeloma and colorectal cancer. Notable findings from the CIRCULATE-Japan trial indicate a >94% pre-surgical detection rate for early-stage colorectal cancer using Signatera. The study emphasizes the test's non-invasive approach compared to traditional bone marrow aspirations and its potential for improved patient monitoring.

Natera, Inc. (NASDAQ: NTRA) announced initial results from the CIRCULATE-Japan trial, the largest MRD-guided study to date, with data from over 1,500 patients. The findings revealed pre-surgical ctDNA detection rates of 95% in stage II-III colorectal cancer and a longitudinal relapse sensitivity of 92%. The trial also noted low failure rates in testing. These results will be presented at the 2021 ASCO Annual Meeting scheduled for June 4-8, 2021. The Signatera™ test is pivotal in personalizing cancer treatment and monitoring.

Natera, Inc. (NASDAQ: NTRA) reported a robust first quarter 2021 with total revenues reaching $152.3 million, a 62% increase compared to $94.0 million in Q1 2020. Product revenues grew 36% to $118.4 million. The company processed 348,200 tests, up 48% year-over-year. Natera raised its 2021 revenue guidance by $50 million, anticipating full-year revenue of $550-$575 million. However, net loss for the quarter was $63.9 million, or ($0.74) per share, an increase from $35.4 million, indicating ongoing challenges despite revenue growth.

Natera, Inc. (NASDAQ: NTRA) will present four posters at the 2021 ASCO Annual Meeting from June 4-8, focusing on the Signatera molecular residual disease (MRD) test in colorectal cancer and multiple myeloma. Recent studies showcased Signatera's 100% effectiveness in detecting cancer recurrence in early-stage ovarian cancer, significantly ahead of radiological findings. The presentation aims to set a new benchmark for MRD assay performance, with additional evidence on Signatera's clinical validity across various cancer types.