Natera, Inc. - NTRA STOCK NEWS

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.

Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA testing, will announce its first-quarter financial results on May 6, 2021, after market close. The company is set to host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to discuss these results along with its business activities and future outlook.

Investors can participate via live dial-in or access the webcast for details. Natera focuses on advancing genetic testing services in women's health, oncology, and organ health, leveraging its CAP-accredited laboratories in Texas and California.

Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA testing, announced that the Centers for Medicare & Medicaid Services (CMS) has established a pathway for future coverage of its Prospera donor-derived cell-free DNA test for assessing transplant rejection in various solid organs. This follows existing coverage for kidney transplants. Natera has conducted over 3 million cfDNA tests and emphasizes the test's non-invasive nature and high precision. The release highlights the growing acceptance of dd-cfDNA monitoring as essential for organ transplant patient care.

Natera, Inc. (NASDAQ: NTRA) has introduced the first wave of its Panorama AI innovations, enhancing its non-invasive prenatal testing (NIPT) capabilities. Key improvements include:

• Increased positive predictive value for 22q11.2 deletion syndrome to 53%, the highest in the industry.
• 50% reduction in the no-call rate for aneuploidies with maintained sensitivity.
• Lowered cost of goods sold (COGS) due to workflow optimizations.

The changes aim to strengthen Natera's position in the NIPT market and are expected to contribute to profitability in 2021.

Natera, Inc. (NASDAQ: NTRA) has partnered with Tesis Labs to enhance prenatal genetic testing services across the U.S., including Texas, Colorado, and Arizona. This collaboration aims to improve access to genetic testing for over 4 million pregnancies annually, leveraging Tesis’s advanced laboratory capabilities in Lafayette, Colorado. Both companies emphasize the importance of early screening for informed healthcare decisions, thereby broadening Tesis's testing offerings and strategically positioning Natera in a growing market.