Natera Inc Stock Price, News & Analysis

Natera announced that the CMS has issued a final local coverage determination for pan-cancer immunotherapy monitoring using its Signatera molecular residual disease test. This coverage applies to Medicare patients undergoing immunotherapy, significantly expanding access to personalized monitoring. The Signatera test has shown high predictive accuracy in identifying non-responders early in treatment, aiming to improve cancer care outcomes. Natera sees this development as a crucial step in enhancing treatment decisions across various tumor types.

Natera, Inc. (NASDAQ: NTRA) reported a strong third quarter for 2021, achieving $158.1 million in total revenues, a 61.1% increase year-over-year. Product revenues rose to $150.7 million, driven by a 55.4% increase in processed tests, totaling 407,300. Despite a net loss of $151.3 million or ($1.63) per diluted share, the company raised its 2021 revenue guidance to $615-$625 million. Significant advancements include an exclusive biobank license and positive results from the Trifecta Study in kidney transplant.

Natera, Inc. (NASDAQ: NTRA) announced initial results from the Trifecta study, the largest biopsy-matched evaluation of donor-derived cell-free DNA (dd-cfDNA) in kidney transplant recipients. The study analyzed over 300 biopsy-matched samples, revealing that the Prospera test with quantification demonstrated an AUC of 0.81 for rejection detection, improving to 0.91 when differentiating rejection from quiescence. Natera anticipates publishing comprehensive results in early 2022, reinforcing its leadership in cfDNA technology.

Natera, Inc. (NASDAQ: NTRA) will announce its third-quarter 2021 financial results on November 4, 2021, after market close. A conference call to discuss these results, along with business activities and financial outlook, will take place at 1:30 p.m. PT (4:30 p.m. ET). Investors can join the call via live dial-in or webcast, with options for domestic and international participants. A replay of the webcast will be available later at investor.natera.com.

Natera, Inc. (NASDAQ: NTRA) has launched the Prospera Lung test, expanding its organ health offerings to include lung transplant assessments. Validated in the VALID study, this non-invasive test achieves a negative predictive value of 97.33% and 89.06% sensitivity, distinguishing between stable patients and acute rejection effectively. Natera also announced two new studies to compare Prospera against traditional biopsy methods. The company aims to improve patient outcomes among lung transplant recipients, addressing a significant clinical need for accurate monitoring.

Natera, Inc. (NASDAQ: NTRA) announced a new study published in Clinical Cancer Research validating its Signatera test for assessing tumor growth rates and predicting survival in early-stage colorectal cancer. This multi-center study involved 168 patients and demonstrated that MRD-positive patients can be stratified based on circulating tumor DNA (ctDNA) growth rates. Key findings included a 9.8-month lead time for recurrence detection and the association of ctDNA clearance with improved survival outcomes, showcasing the value of personalized ctDNA analysis in clinical decision-making.

Natera has completed the VALID Study, the largest clinical validation of a commercial cell-free DNA test for lung transplantation. The study involved 204 plasma samples from 104 lung transplant recipients and was accepted as a late-breaking abstract for presentation at CHEST 2021 (October 17-20). This study highlights the significance of donor-derived cell-free DNA (dd-cfDNA) testing in improving patient outcomes. Natera's Prospera test has previously shown success in kidney and heart transplant assessments, indicating its potential in lung transplant situations as well.

Natera, Inc. (NASDAQ: NTRA) received a favorable ruling from the Delaware Federal District Court, invalidating all three patents asserted against it by CareDx. The court determined these patents are legally invalid due to their patent-ineligible subject matter. Natera anticipates this decision will withstand an appeal and is actively pursuing its own infringement claims against CareDx concerning its '658 and '724 patents. These patents are part of Natera's extensive organ health intellectual property portfolio, showcasing the company's contribution to cfDNA-based diagnostics.

Natera, Inc. (NASDAQ: NTRA) showcased new data on the Signatera personalized molecular residual disease (MRD) technology at the 2021 ESMO Congress. The studies highlighted include the predictive capacity of ctDNA for relapse in gastroesophageal cancers, the use of ctDNA dynamics in assessing treatment response in uveal melanoma, and the impact of CHIP mutations on patient outcomes. Results indicated ctDNA detected in 93.3% of samples at baseline for gastroesophageal cancer, and ctDNA reduction was linked to improved overall survival in uveal melanoma.