Natera, Inc. - NTRA STOCK NEWS

Natera, a leader in cell-free DNA testing, announced that its Signatera test will be utilized in the DARE study, a Phase II clinical trial evaluating palbociclib (IBRANCE®) for treating early-stage HR-positive, HER2-negative breast cancer. The trial aims to enroll approximately 100 MRD-positive patients to assess the efficacy of palbociclib in second-line adjuvant therapy. Signatera will monitor patient eligibility and treatment effectiveness. This collaboration with Yale and Criterium/ABRCC highlights the potential of personalized MRD testing in improving cancer management.

Natera, Inc. (NASDAQ: NTRA) has received a draft local coverage determination (LCD) from CMS’s Molecular Diagnostics Program for expanded coverage of its Signatera circulating tumor DNA (ctDNA) test, which monitors minimal residual disease (MRD) in cancer patients. The LCD allows for coverage of Signatera in various solid tumors and builds on Medicare's recent colorectal cancer coverage decision. The Signatera test boasts a 100% positive predictive value for identifying treatment non-responders and can detect residual disease up to 2 years earlier than standard methods.

Natera (NASDAQ: NTRA) announced its participation in the 2020 European Society for Medical Oncology (ESMO) virtual meeting, where it will present new data on its personalized molecular residual disease (MRD) test, Signatera, from September 19-21, 2020. The company will showcase four abstracts, including one oral presentation and three posters, focused on MRD detection and tumor evolution in colorectal and esophageal cancers. Natera emphasizes that Signatera provides clinically actionable insights for managing solid tumors, enhancing monitoring and treatment decisions.

Natera, Inc. (NASDAQ: NTRA) has launched a program aimed at improving care for organ transplant patients with a history of cancer. This initiative utilizes the Signatera™ test for assessing molecular residual disease (MRD) and the Prospera™ test for monitoring transplant rejection. With a significant portion of transplant candidates having past cancer histories, the program seeks to establish data-driven guidelines for better patient management. Key studies include CONCERT for colorectal cancer patients and SIGNAL for liver cancer recurrence monitoring.

Natera, Inc. (NASDAQ: NTRA) announced that Noridian, the Medicare Administrative Contractor for Northern California, has approved Medicare benefits for the serial use of the Signatera molecular residual disease (MRD) test in colorectal cancer patients. This coverage determination aligns with a recent positive decision from the CMS Molecular Diagnostics program, effective October 18, 2020. The Signatera test, designed for personalized monitoring of cancer, has received FDA Breakthrough Device Designation and demonstrates high sensitivity in detecting residual disease.

Natera, Inc. (Nasdaq: NTRA) announced the pricing of its underwritten public offering of 4,166,666 shares at $60.00 per share, expected to close on September 15, 2020. The underwriters have a 30-day option to purchase an additional 624,999 shares. J.P. Morgan, Morgan Stanley, Cowen, and SVB Leerink serve as joint book-running managers. The offering follows an effective shelf registration statement filed with the SEC on September 9, 2020. Natera aims to innovate in cell-free DNA testing with a focus on women's health, oncology, and organ health.

Natera, Inc. (NASDAQ: NTRA) will present at the Morgan Stanley 18th Annual Global Healthcare Conference on September 14, 2020, at 9:00 a.m. PT (12:00 p.m. ET). The webcast will feature insights from Steve Chapman, CEO, and Mike Brophy, CFO, discussing recent developments and business activities. Interested parties can access the live presentation and archived content through investor.natera.com. Natera specializes in cell-free DNA testing, focusing on women's health, oncology, and organ health.

Natera, Inc. (Nasdaq: NTRA) announced a proposed follow-on public offering of $250 million in common stock, with an additional $37.5 million in shares potentially available to underwriters. The offering is subject to market conditions and no assurance is given regarding its completion or terms. This follows the filing of an automatically effective shelf registration statement with the SEC. J.P. Morgan, Morgan Stanley, Cowen, and SVB Leerink will manage the offering, which aims to support Natera's mission in cell-free DNA testing.

Natera, Inc. (NASDAQ: NTRA) announced that the CMS Molecular Diagnostics Program has finalized a local coverage determination (LCD) for Medicare to cover its Signatera molecular residual disease (MRD) test in stage II and III colorectal cancer patients. This LCD aligns with a prior draft from August 2019 and includes two main uses: risk stratification after surgery and recurrence monitoring. Signatera can detect cancer recurrence up to 16.5 months earlier than standard imaging methods. This development is a significant milestone for Natera in transforming cancer care.