Personalized Tumor-Informed Assay Helps Patients Get Ahead of Cancer

Over the past several years, research has shown that minimal or molecular residual disease (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. Now, a newly-available platform can help detect MRD in patients with solid tumors.

Invitae Corporation (San Francisco, CA, USA) has announced full access to its Personalized Cancer Monitoring (PCMTM) platform to help detect MRD in patients with solid tumors. Invitae PCM is a pan-cancer, tumor-informed liquid biopsy assay, uses a next generation sequencing (NGS) to analyze DNA (ctDNA) in a patient's plasma. Invitae PCM uses a novel set of personalized assays based on a patient's tumor to detect circulating tumor ctDNA in blood, offering the ability to perform risk stratification, response assessment to treatment and detection of cancer recurrence, based on recent studies.

In order 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.

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.

"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."

"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.

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Invitae Corporation 

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