Invitae Launches Enhanced Chemistry of MRD Test to Better Serve Biopharmaceutical Clinical and Research Partnerships

– Helps to detect circulating tumor DNA (ctDNA) as a biomarker in clinical research and clinical trials for solid tumor malignancies –

– May provide real-time data on therapy response, support patient prognostic stratification and enable early detection of residual disease – 

SAN FRANCISCO, Nov. 6, 2023 /PRNewswire/ -- Invitae (NYSE: NVTA), a leading medical genetics company, today announced enhanced chemistry of its Invitae Personalized Cancer Monitoring™ platform that helps detect circulating tumor DNA (ctDNA) as a biomarker for solid tumor malignancies. ctDNA can provide real-time insights on patient response or disease progression, support patient prognostic stratification and enable early detection of residual disease.

The enhanced assay, which received Clinical Laboratory Improvement Amendments (CLIA) approval, features a flexible patient-specific panel design of between 18 and 50 variants, demonstrating a sensitivity of >99% for detecting ctDNA at variant allele frequencies as low as 0.005%. In addition, the company has also received CLIA approval on the whole exome sequencing component of PCM as a stand-alone comprehensive genomic profiling (CGP) assay to permit reporting of tumor profiles.

In our commitment to continual innovation, the enhanced assay achieves a number of benefits. Compared to our prior version, the enhanced assay permits a new lower mass input limit that results in the same sensitivity as the prior version with less cell-free DNA (cfDNA), enabling Invitae to test samples that might have been previously rejected. The enhanced assay also involves fewer steps that will increase capacity and reduce the burden of materials and labor costs. Lastly, the enhanced chemistry is automation friendly enabling scale and supporting future growth.

"This focused launch and enhanced chemistry will enable biopharma partners to detect recurring disease early," said Bob Daber, Ph.D., chief scientific officer of Invitae. "This will potentially help set MRD as a standard practice in clinical studies and increase the velocity of drug development. Our vision is that insights gained from Invitae Personalized Cancer Monitoring will lead to research breakthroughs that positively influence patient journeys."

"With Invitae Personalized Cancer Monitoring, biopharma researchers will have information they need to inform clinical trial design and study patient outcomes, ultimately to help bring new cancer therapies that benefit patients to market," added Dr. Daber.

To learn about Invitae Personalized Cancer Monitoring, please contact [email protected]. 

About Invitae Personalized Cancer Monitoring™ 

Invitae Personalized Cancer Monitoring is a multi-cancer, tumor-informed, long-term monitoring assay that incorporates next-generation sequencing libraries featuring both unique molecular identifiers (UMIs) and updated anchored multiplex PCR (AMP) chemistry. Invitae Personalized Cancer Monitoring provides personalized ctDNA detection and quantitation from the peripheral blood in patients with solid tumors.

Biopharma researchers can utilize the validated Invitae Personalized Cancer Monitoring platform to detect residual cancer at the molecular level. By assessing the presence and levels of ctDNA over time, Invitae Personalized Cancer Monitoring provides a highly sensitive approach to detect residual cancer in patients who have undergone surgery and other definitive therapies, thus informing further diagnostic and therapeutic decisions, leading to potentially improved outcomes. The assay can also provide molecular information on the extent of response to therapeutic interventions, in various clinical settings, which may assist in optimizing clinical studies and accelerating drug development.

Currently established clinical practice involves utilizing imaging as a means to detect residual disease and tumor changes, which might result in delayed detection of disease recurrence and inaccurate assessment of therapeutic response. Biopharma researchers need a faster and more reliable way to understand therapeutic responses to novel drug regimens. The Invitae Personalized Cancer Monitoring assay may provide such information. For example, in a study of non-small cell lung cancer, a ctDNA assay based on the Invitae Personalized Cancer Monitoring platform detected relapse prior to standard clinical diagnosis via imaging by almost four months.

About Invitae
Invitae (NYSE: NVTA) is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their families. Invitae's genetics experts apply a rigorous approach to data and research, serving as the foundation of their mission to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people.

To learn more, visit invitae.com and follow for updates on Twitter, Instagram, Facebook and LinkedIn @Invitae.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits of the enhanced chemistry of the Invitae Personalized Cancer Monitoring^TM test; that the company's focused launch and enhanced chemistry will enable biopharma partners to detect recurring disease early, potentially help set MRD as a standard practice in clinical studies and increase the velocity of drug development; and the company's vision that insights gained from its test will lead to research breakthroughs that positively influence patient journeys. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company's ability to grow its business in a cost-efficient manner; the company's history of losses; the company's ability to maintain important customer relationships; the company's ability to compete; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the applicability of clinical results to actual outcomes; risks associated with litigation; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2023. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Invitae PR contact:
Renee Kelley
[email protected]  

SOURCE Invitae Corporation