Natera Inc Stock Price, News & Analysis

Natera, Inc. (NASDAQ: NTRA) announced a prospective, randomized controlled trial demonstrating the clinical utility of its Prospera test. The study, published in International Urology and Nephrology, showed that nephrologists using the Prospera test detected rejections more effectively than those in the control group. Key findings include a 300% increase in biopsy confirmation of rejection and a 137% improvement in treatment decisions preserving kidney function. The Prospera test enhances early detection and management post-kidney transplant, emphasizing its role in nephrology.

Natera, Inc. (NASDAQ: NTRA) has partnered with Massachusetts General Cancer Center to initiate a multi-center, Phase II clinical trial named LEADER, focusing on Ribociclib (Kisqali®) for ER-positive breast cancer treatment. The trial will assess tumor molecular response in patients with detectable circulating tumor DNA (ctDNA) post-surgery. Utilizing Natera's Signatera test, the study aims to identify minimally residual disease (MRD) and evaluate treatment effectiveness, potentially reducing relapse risks in early-stage breast cancer patients.

Natera, Inc. (NASDAQ: NTRA) announced the receipt of the CE mark for its Signatera test, a personalized ctDNA assay designed for molecular residual disease (MRD) assessment in cancer patients. This milestone allows Natera to distribute Signatera across Europe, supporting patient management and clinical research. The test has been validated in multiple cancer types and represents an advancement in cancer care, particularly in monitoring treatment effectiveness. With 3.7 million new cancer cases annually in Europe, the CE mark expands Natera's global reach in personalized cancer therapy.

Natera, Inc. (NASDAQ: NTRA) announced on August 18, 2020, that the American College of Obstetrics and Gynecology (ACOG) and Society of Maternal Fetal Medicine (SMFM) have updated their guidelines to recommend non-invasive prenatal testing (NIPT) for aneuploidy screening for all patients, irrespective of age. The guidelines recognize cfDNA testing's sensitivity and its applicability in twin pregnancies. The updated recommendation is anticipated to enhance NIPT's coverage and usage. Natera has a robust clinical backing, evidenced by 22 peer-reviewed publications and the SMART study, which aims to further validate NIPT's effectiveness.

Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA testing, has filed a lawsuit against ArcherDX, Inc. for the infringement of its U.S. Patent No. 10,731,220, issued on August 4, 2020. The lawsuit, filed in the U.S. District Court of Delaware, alleges that ArcherDX's oncology products violate Natera's patented methods related to DNA testing. This follows a prior suit filed against ArcherDX in January 2020 regarding four additional patents. Natera seeks both monetary damages and injunctive relief for these infringements.

Natera, Inc. (NASDAQ: NTRA) reported robust Q2 2020 results, processing approximately 234,100 tests, a 21% increase from Q2 2019. Total revenues reached $86.5 million, up from $74.4 million year-over-year. Gross profit rose to $39.5 million, achieving a 46% gross margin. However, the company faced an operating loss of $51.6 million compared to $28.6 million the previous year. Natera anticipates total 2020 revenues between $345 million and $365 million, with a projected cash burn of $125 million to $155 million.

Natera, Inc. (NASDAQ: NTRA) announced a validation of its Signatera™ circulating tumor DNA (ctDNA) technology in a study published in Nature Cancer. The research shows Signatera's effectiveness in assessing tumor response to immunotherapy across 25 solid cancer types. Key findings include ctDNA detection in 98% of cases before treatment and the ability to predict treatment non-response with 100% accuracy after just 6 weeks. The study highlights the clinical utility of ctDNA-based surveillance to distinguish true disease progression from pseudo-progression, addressing an unmet clinical need.

Natera, a leader in cell-free DNA testing, will announce its Q2 2020 financial results on August 5, 2020, after market close. A conference call is scheduled for 1:30 p.m. PT to discuss the results and future outlook. Natera's labs are certified under CLIA, providing essential genetic testing focused on women's health, oncology, and organ health. Investors can access a replay of the webcast at Natera's investor relations website.