Natera’s Commitment to Improving Health Care
Health care is complex, and many people have unmet medical needs. With more personalized health information, more informed care decisions can be made.
At Natera, we aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier, more targeted interventions that can help lead to longer, healthier lives. Our aim is ambitious. It requires a relentless drive for scientific excellence and an unwavering focus on responsible business practices.
Our Driving Force
At Natera, we are driven by the person behind each test. We never lose sight of the fact that every test we run impacts a real person—someone relying on the information we provide to help them make more informed decisions in important health moments. This is our motivation, and it grounds our actions.
Clinical Expertise Guides Test Development
We know that in order for our tests to deliver real benefits, they need to meet real needs. In 2021, we invested more than $260 million into research and development (R&D). Our genetic tests and diagnostics have been validated in more than 100 scientific publications. They have been used by more than 5 million people to help make more informed decisions in oncology, women’s health, and organ health.
R&D and Millions of Tests Inform Our Innovation
We currently have more than 100 clinical trials underway. Results from these trials could provide the foundation for introducing new applications for our genetic tests and diagnostics.
Through the data we have amassed through our in-house efforts and clinical research studies, coupled with experience from the more than 6 million tests we’ve processed, we continue to optimize the performance of our existing tests.
In 2021 alone, we launched a noninvasive transplant assessment for lung and heart transplant recipients who face a high risk of rejection and currently undergo invasive biopsies to screen for rejection. Data from a clinical study involving cancer patients led to a Centers for Medicare and Medicaid local coverage designation for immunotherapy response monitoring with Signatera™. We launched improved monitoring for kidney transplant recipients as well as a new artificial intelligence algorithm for Panorama™, our noninvasive prenatal screening test.
Scientific Community Partnerships Validate and Advance Our Tests
As part of our ongoing R&D efforts, we engage with the scientific community in several ways:
Academic Research Centers
Our scientists collaborate with researchers from top academic research centers to help evaluate and validate our technology in people with different medical conditions and of different ages and ethnic backgrounds. Data from these partnerships are often published in medical journals, presented at scientific meetings, and shared with the broader scientific and medical community.
A few recent highlights of such partnerships include:
- Data from the CIRCULATE-Japan study, the largest prospective, multi-center, MRD-guided trial to date in colorectal cancer (CRC), which used Signatera to monitor molecular residual disease (MRD) in patients with stage I-IV CRC, were presented at the American Society of Clinical Oncology’s (ASCO) 2022 Gastrointestinal Cancers Symposium.
- Data from the I-SPY 2 trial, which used Signatera to monitor MRD in patients with locally advanced breast cancer receiving chemotherapy, radiation therapy, or endocrine therapy prior to surgery, were published in the Annals of Oncology.1
- Data from the SMART study, the largest prospective, noninvasive prenatal testing study of more than 18,000 pregnant people, were published in the American Journal of Obstetrics and Gynecology.2
- Data on the ability of single-gene noninvasive prenatal testing (NIPT-SGD) to detect 25 genetic conditions that collectively affect 1 in 600 pregnancies were published in Ultrasound in Obstetrics & Gynecology.3
- Data from the Trifecta study, the largest multisite, prospective, fully biopsy-matched cohort with donor-derived cell-free DNA (dd-cfDNA) analysis for kidney transplant recipients conducted to date, were presented at American Transplant Congress.
- Data from the VALID Study, the largest prospective study to date of a commercial dd-cfDNA test for lung transplant assessment, were presented at the 2021 American College of Chest Physicians (CHEST) international online meeting.
We partner with pharmaceutical companies to learn if our tests can be used in new ways. For example, pharmaceutical companies have used our technology to help determine how well drugs being tested in clinical trials are working. They have also used our technology to help determine which patients benefit from a particular drug, and which do not.
We engage with medical professionals about national and global efforts to implement genetic testing and diagnostics and regularly attend medical society meetings held by the American Society of Clinical Oncology (ASCO), American College of Obstetricians and Gynecologists (ACOG), Society for Maternal and Fetal Medicine (SMFM), and the American Society of Transplant Surgeons (ASTS), among others.
At these meetings, we present data and share how our tests are working. At Natera, we also connect with our colleagues to learn about their latest research and share opportunities to improve genetic testing and diagnostics across the field.
Technology Makes the Promise of Personalized Medicine a Reality
In the just over two decades since the first complete human genome was sequenced, the science of genetic testing and diagnostics has advanced by leaps and bounds. We’ve developed cutting-edge cell-free DNA technology and advanced sequencing techniques. Using this technology, we can now track how well a person’s cancer is responding to therapy, prenatally screen for a wide range of genetic conditions, and assess early signs of organ rejection.
But none of these or other remarkable advances will fulfill their potential of personalizing medicine without data demonstrating their value to real people in the real world. This is why we have placed R&D at the forefront of everything we do, and why we have gathered a diverse and talented team of experts to help accomplish our goal.
Learn more here.
1Magbanua MJM, et al. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021;32(2):229-239. https://doi.org/10.1016/j.annonc.2020.11.007
2Dar P, et al. Cell-free DNA screening for prenatal detection of 22q11.2 deletion syndrome. Am J Obstet Gynecol. 2022;S0002-9378(22)00006-0. https://doi.org/10.1016/j.ajog.2022.01.002
3Mohan P, et al. Clinical experience with non-invasive prenatal screening for single-gene disorders. Ultrasound Obstet Gynecol. 2022;59(1):33-39. https://doi.org/10.1002/uog.23756