Invitae Launches Full Access to its Liquid-Based Personalized Cancer Monitoring Platform to Help Detect Disease Earlier

– Personalized tumor-informed assay helps patients get ahead of cancer –

SAN FRANCISCO, March 17, 2022 /PRNewswire/ -- Invitae (NYSE: NVTA), a leading medical genetics company, today announced full access to its Personalized Cancer Monitoring (PCM^TM) platform to help detect minimal or molecular residual disease (MRD) in patients with solid tumors. Invitae PCM uses a novel set of personalized assays based on a patient's tumor to detect circulating tumor DNA (ctDNA) in blood, offering the ability to perform risk stratification, response assessment to treatment and detection of cancer recurrence, based on recent studies. 

"Relapse risk stratification is a clinical need for many patients undergoing treatment for solid tumors and is best served by up-to-date molecular tools to complement and improve upon the standard of care methods for recurrence detection," said Robert Nussbaum, M.D., chief medical officer, Invitae. "The PCM platform complements current monitoring methods, and has the ability to determine a cancer therapy's effectiveness earlier than those methods for many patients, allowing clinicians the opportunity to refine treatment options."

Over the past several years, research from Invitae and the greater scientific community, including the TRACERx study led by Professor Charles Swanton at the Francis Crick Institute and University College London (UCL), and funded by Cancer Research UK, has shown that MRD monitoring can reliably identify lung cancer patients at high risk of relapse, detect post-surgical recurrence often earlier than standard imaging, assess therapy response, and potentially act as a surrogate for clinical trial endpoints. With these capabilities, MRD monitoring promises to shorten clinical trials and accelerate the development of potentially life-saving new drugs. Invitae PCM is a pan-cancer, tumor-informed liquid biopsy assay, co-developed with the TRACERx consortium, that uses a next generation sequencing (NGS) to analyze ctDNA in a patient's plasma. 

"MRD is an important biomarker in the adjuvant and surveillance period," said Professor Charles Swanton, MBPhD, FRCP, FMedSci, FRS, FAACR, at the Francis Crick Institute and UCL Cancer Institute and Chief Clinician of Cancer Research UK. "As we've seen in the TRACERx study, PCM provides prognostic information, can aid in cases of radiographic ambiguity, and demonstrates high clinical sensitivity and specificity."

Liquid biopsy tests have been available for therapy selection, but to identify MRD at an earlier stage than conventional methods before patients clinically relapse, the technology must be sensitive enough to detect ctDNA at very low levels. Additionally, an MRD test with high specificity is also needed to reduce the likelihood of false positive results. The PCM test utilizes advanced technologies to arrive at high levels of sensitivity and specificity, detecting tumor DNA at very low levels of concentrations in peripheral blood. Validation studies demonstrate greater than 99.9% sensitivity in detecting ctDNA at a 0.008% variant allele frequency.

"We are excited about PCM availability globally, as this is an evolving area where we have invested over the last year and we believe has the potential to give patients the information needed to understand their recurrence risk to fight and beat the disease," said Sean George, Ph.D., co-founder and CEO of Invitae. 

Each assay is custom designed to detect a patient's unique tumor signature, allowing for personalized results to guide treatment decisions. Invitae PCM requires both blood and tumor tissue samples from the patient to conduct tumor-normal whole exome sequencing (WES). Based on the results, Invitae's proprietary algorithm selects 18-50 tumor-specific variants to include on the patient's custom-designed ctDNA panel. This range of variants allows for a balance of highly sensitive and specific MRD detection in cancers that have lower or higher mutational burdens. 

If an MRD-positive result is obtained at any point in a cancer patient's journey, the clinician and patient can discuss the implications of the result and the most appropriate treatment or clinical trial options. "This molecular knowledge impacts cancer patients throughout their cancer journey, making this a mainstay in precision oncology," said George.

Invitae is actively expanding the research portfolio globally to continue to gather data on PCM clinical utility as well as MRD-guided studies. Invitae anticipates multiple publications this year across its PCM studies in lung, breast, head and neck, and GI tumors as well as several prospective studies kicking off in the first half of the year. These prospective studies include a pan-tumor study (MARIA) and several studies in breast and GI cancers, including ARTEMIS, a study examining Invitae's PCM offering specifically for patients with pancreatic cancer. The study will be conducted in partnership with a high profile institution near Tokyo, the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. Sample collection will begin in Q2 2022. 

For more information about Invitae PCM, visit Invitae. 

About Invitae
Invitae Corporation (NYSE: NVTA) is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time and lower prices. For more information, visit the company's website at invitae.com.

About TRACERx Study
TRACERx (TRAcking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and in immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analysing how their cancer develops. TRACERx is led by the University College London via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.

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 availability, features and potential impact of the company's PCM platform; the company's beliefs regarding the benefits of MRD monitoring; and the company's plans to continue to gather data on PCM clinical utility and conduct MRD-guided studies. 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 history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; 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 Annual Report on Form 10-K for the year ended December 31, 2021. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

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SOURCE Invitae Corporation