Invitae's PCM Assay for Minimal Residual Disease Receives its First Commercial Coverage

Rhea-AI Summary

Invitae (NYSE: NVTA) announced that its Personalized Cancer Monitoring (PCM™) assay has received its first commercial coverage from Blue Shield of California for all solid tumors. Effective from March 1, 2023, the policy deems the test medically necessary for cancer patients (stage I-IV) post-surgery. The PCM assay detects circulating tumor DNA (ctDNA) in blood, aiding in risk assessment and monitoring for cancer recurrence. M.D. Robert Nussbaum emphasized this coverage as a significant advancement for patient care, with ongoing efforts to expand clinical evidence and reimbursement pathways.

Positive

• First commercial coverage for PCM assay received from Blue Shield of California.
• Coverage considers PCM assay medically necessary for stages I-IV cancer post-surgery.
• PCM assay helps in detecting minimal residual disease (MRD), enhancing patient care.

Negative

• None.

– Blue Shield of California has over 3 million covered members in CA –

SAN FRANCISCO, March 6, 2023 /PRNewswire/ -- Invitae (NYSE: NVTA), a leading medical genetics company, today announced that its Personalized Cancer Monitoring (PCM™) assay, which helps detect minimal residual disease (MRD) in patients, has obtained its first commercial coverage in all solid tumors by Blue Shield of California. The policy, effective as of March 1, 2023, considers the test medically necessary for patients with stage I-IV cancer after surgical intervention for adjuvant or targeted therapy and/or monitoring for relapse or progression. 

Invitae's PCM uses a novel set of personalized assays based on a patient's tumor to detect circulating tumor DNA (ctDNA) in blood, assisting with risk stratification, assessing response to treatment and detecting cancer recurrence. 

"We are very pleased with this coverage decision because it recognizes the utility of PCM in detecting MRD, thereby improving the clinical care of cancer patients," said Robert Nussbaum, M.D., chief medical officer at Invitae. "We are continuing to generate additional clinical evidence as well as securing other reimbursement pathways. Overall, we are encouraged to see increasing access to MRD testing and view the coverage decision as a great step forward for patients."

For more information, visit invitae.com. 

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 company's beliefs regarding the coverage decision, the utility of PCM and its benefits for patients; and the company's plans regarding generating additional clinical evidence and securing other reimbursement. 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 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, 2022. 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
pr@invitae.com 
(628) 213-3283

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SOURCE Invitae Corporation

FAQ

What is Invitae's Personalized Cancer Monitoring (PCM) assay?

Invitae's PCM assay is a test that detects minimal residual disease (MRD) in patients with solid tumors by analyzing circulating tumor DNA in blood.

When did Invitae receive commercial coverage for its PCM assay?

Invitae received commercial coverage for its PCM assay from Blue Shield of California, effective March 1, 2023.

What types of cancer does the PCM assay cover?

The PCM assay covers all solid tumors for patients diagnosed with stage I-IV cancer.

How does the PCM assay benefit cancer patients?

The PCM assay assists in risk stratification, monitoring treatment response, and detecting cancer recurrence, improving overall patient care.

Who announced the coverage for Invitae's PCM assay?

The coverage for Invitae's PCM assay was announced by Blue Shield of California.