Natera, Inc. - NTRA STOCK NEWS

Natera (NASDAQ: NTRA) has announced a new peer-reviewed study validating its Signatera molecular residual disease (MRD) assay for oligometastatic colorectal cancer (oligo mCRC). The study involved 112 patients and demonstrated that Signatera identified MRD positivity in 54% of cases post-surgery, with a sensitivity of 72%. Serial testing increased sensitivity to 91%, with 100% overall survival among those who remained MRD-negative. These findings aim to establish Signatera as a vital prognostic biomarker for guiding treatment decisions in this patient population.

Natera, a leader in cell-free DNA testing, announced the pricing of its public offering of 4,500,000 shares at $113.00 each, with expected closing on July 26, 2021. The offering includes a 30-day option for underwriters to buy an additional 675,000 shares. The offering is underpinned by a shelf registration statement filed with the SEC. Morgan Stanley, Goldman Sachs, Cowen, and SVB Leerink are managing the offering. Natera aims to enhance disease management globally, focusing on women's health, oncology, and organ health.

Natera, Inc. (Nasdaq: NTRA) has announced a proposed follow-on public offering to raise $350 million through the sale of its common stock. Additionally, underwriters may purchase up to $52.5 million more in shares. The offering is contingent on market conditions, and there are no guarantees regarding its completion or the terms. Major banks including Morgan Stanley and Goldman Sachs are managing the offering. This move is part of Natera's ongoing efforts to fund its operations and expand its impact in cell-free DNA testing.

Natera, Inc. (Nasdaq: NTRA) reported preliminary financial results for the second quarter of 2021, showcasing record growth. Expected revenues range from $138 million to $141 million, marking a 60% year-on-year increase from $86.5 million in Q2 2020. Product revenues are anticipated to be $135 million to $137 million, a 70% rise from $80.4 million in the same period last year. The company also processed approximately 370,000 tests, up 58% from 234,000. However, a loss from operations is projected between $113 million and $117 million, compared to $51.7 million in Q2 2020.

Natera, Inc. (NASDAQ: NTRA) presented new data on its molecular residual disease (MRD) assay, Signatera, at the ESMO GI 2021 conference. This includes results from the CIRCULATE-Japan trial, the largest MRD-guided study in colorectal cancer (CRC), featuring over 800 patients. Signatera demonstrated a 93.1% sensitivity for relapse detection, showcasing improved disease-free survival rates for MRD-negative patients. The study is pivotal in potentially altering early-stage CRC treatment guidelines and underscores the significance of personalized MRD testing for patient care.

Natera, a leader in cell-free DNA testing, partners with BGI Genomics to launch the BGI/Natera Signatera Assay in China. This assay, which detects molecular residual disease in various cancers, enables earlier identification compared to standard imaging. Launched two years after their partnership, the assay supports innovative trial design and offers biopharmaceutical companies opportunities for companion diagnostic registrations in both China and the U.S. The collaboration aims to enhance precision medicine and improve treatment outcomes for cancer patients.

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.