Natera, Inc. is a diagnostics company, which engages in the discovery, development, and commercialization of genetic testing services. It provides Panorama non-invasive prenatal test (NIPT), Vistara, horizon carrier screening (HCS), spectrum pre-implantation genetic screening and spectrum pre-implantation genetic diagnosis, Anora products of conception (POC) and non-invasive paternity testing (PAT). The company was founded by Matthew Rabinowitz and Jonathan Sheena in November 2003 and is headquartered in Austin, TX.
相关临床试验
36
9 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2004
进行中（未招募）
5
13.9%
已完成
14
38.9%
尚未招募
4
11.1%
招募中
8
22.2%
终止
3
8.3%
撤回
2
5.6%
暂无批准数据
- The FDA extended its review of Exelixis' NDA for zanzalintinib plus atezolizumab in metastatic colorectal cancer by three months, setting a new PDUFA date of March 3, 2027. - The extension followed Exelixis' submission of updated safety and efficacy data in response to an FDA information request, which the agency classified as a major amendment. - The filing is based on the Phase 3 STELLAR-303 trial, where the combination reduced the risk of death by 20% versus regorafenib in the intent-to-treat population. - William Blair said the rejection risk remains low given the overall survival benefit, though a second pre-specified analysis in patients without liver metastases missed statistical significance.
- Natera and Angiex have announced a collaboration to use Signatera ctDNA testing for longitudinal response monitoring in Angiex's Phase 1 trial of AGX101. - AGX101 is a TM4SF1-directed Nuclear-Delivered Antibody-Drug Conjugate (ND-ADC) targeting both tumor cells and tumor-associated endothelial cells in advanced solid tumors. - Signatera's personalized ctDNA monitoring may complement imaging by offering additional insights when radiological findings are uncertain. - The partnership underscores the growing role of precision diagnostics in oncology and the potential of ctDNA testing to inform development of a novel drug class.
- Under CEO Reshma Kewalramani, Vertex launched Casgevy, the first FDA-approved CRISPR gene-editing drug, and Journavx, a new class of non-opioid painkillers. - Vertex posted $12 billion in profit in 2025 with a market capitalization exceeding $100 billion, expanding beyond cystic fibrosis into neurological, hematological, and renal diseases. - Bahija Jallal rescued Immunocore from near-collapse, raised $130 million, and secured FDA approval for Kimmtrak, the world's first therapy for inoperable or metastatic uveal melanoma. - GSK's US president Maya Martinez-Davis oversaw five new drug launches in 2025, while Teal Health's Kara Egan brought the first FDA-approved at-home cervical cancer screening kit to market.
- Natera posted a record 34,000-unit sequential increase in Signatera volumes in Q2 2026, driven by FDA approval halo effects and expanded commercial team productivity. - Pending MolDX coverage submissions for additional indications could add $150–$200 to the current Signatera ASP of approximately $1,275, with benefits expected over the next 12–18 months. - The company launched SIGNAL-ER 101, the first in a portfolio of interventional studies using Signatera to guide CDK4/6 inhibitor use in early-stage HR+/HER2- breast cancer. - Natera acknowledged that Q1 weather-related suppression exaggerated Q2 sequential growth and cautioned that Q3 is not expected to repeat the record volume increase.
- The global kidney transplant rejection biomarker market is projected to grow from USD 1,362.8 million in 2026 to USD 3,975.3 million by 2036 at an 11.3% CAGR, driven by increasing adoption of non-invasive liquid biopsy testing. - Donor-derived cell-free DNA (dd-cfDNA) is expected to hold 31.1% of the biomarker type segment in 2026, supported by blood-based sampling and measurable graft-derived injury signals across repeat surveillance visits. - A June 2024 Nature Medicine study covering 2,882 recipients across 14 centers has built confidence for liquid biopsy use in kidney transplant surveillance, accelerating clinical adoption. - Japan leads country-level growth at 13.7% CAGR, followed by the UK at 12.1% and the USA at 11.1%, with transplant centers projected to capture 44.0% of end-user share in 2026.
- Natera's Signatera test received regulatory approval in Japan, becoming the first molecular residual disease (MRD) test approved for patients with colorectal cancer in the country. - Signatera is expected to launch in Japan by the end of 2026, expanding Natera's oncology testing footprint into a new major market. - Natera processed over 800,000 oncology tests in 2025, a 51.6% increase from 2024, reflecting strong demand for blood-based cancer recurrence detection. - The company is now seeking regulatory approval for Signatera's use as a test for muscle-invasive bladder cancer, further broadening its label.
- Natera and Aveta Biomics announced a strategic partnership to support AVTA 30-01, a global Phase 3 registrational trial evaluating APG-157 in locally advanced head and neck squamous cell carcinoma. - APG-157 is a first-in-class oral immunotherapy designed to activate anti-tumor immunity in both immune-cold and immune-hot tumors, with FDA Fast Track and Orphan Drug Designations. - The trial will enroll approximately 826 patients across North America, Europe, Asia-Pacific, and Australia, with enrollment expected to begin in the second half of 2026. - Natera's Signatera ctDNA assay will be used as a secondary endpoint to assess molecular residual disease and treatment response throughout therapy and follow-up.
- Precision oncology has moved from research into routine clinical practice, reshaping risk assessment, treatment selection, and recurrence monitoring through genomic insights. - Circulating tumor DNA (ctDNA) and molecular residual disease (MRD) testing are redefining early-stage cancer management by enabling real-time disease assessment without radiographic findings. - Health systems face operational challenges including standardization of clinical pathways, EHR integration, and the need for molecular tumor boards to scale precision oncology effectively. - The next frontier includes expanding blood-based cancer screening to all cancer types and targeting previously "undruggable" mutations such as KRAS with emerging therapies like Zoldonrasib.
- Natera's Signatera test received PMDA approval in Japan for molecular residual disease detection in colorectal cancer, marking the first regulatory-approved MRD test in the country. - The company plans to commercially launch Signatera in Japan by the end of 2026, expanding its international footprint. - The approval follows Signatera's inclusion in NCCN guidelines for muscle-invasive bladder cancer, prompting BTIG analysts to raise their price target to $270. - Natera reported Q1 2026 revenue of $696.6 million, a 38.8% year-over-year increase, though widening net losses continue to draw investor scrutiny on the path to profitability.
- Exelixis has entered a clinical development collaboration with Merck to evaluate zanzalintinib combined with subcutaneous Keytruda Qlex in the phase 3 STELLAR-316 study for resected stage II/III colorectal cancer patients. - The trial will target high-risk patients who test positive for molecular residual disease following definitive therapy, representing a population with substantial unmet medical need. - STELLAR-316 is expected to initiate in mid-2026, with disease-free survival as the primary endpoint and circulating tumor DNA clearance as a key secondary endpoint. - This collaboration adds external validation to Exelixis' zanzalintinib program, which already has a pending FDA application for metastatic colorectal cancer treatment with a December 2026 target action date.
