Select mdx test for prostate cancer detection added to Cigna insurance coverage

Cigna has expanded their commercial and Medicare Advantage plans to include coverage of Mdxhealth’s Select mdx prostate cancer test for early detection of the disease, announced Mdxhealth in a news release.¹

The test was included in the 2020 NCCN guidelines for the early detection of prostate cancer.

“We are very pleased to announce this expansion of coverage with one of the largest health insurers in the United States, which will cover both commercial lives and Cigna’s substantial Medicare Advantage population. Expanding insurance coverage for our precision diagnostic tests remains a strategic priority at Mdxhealth, and today’s announcement reflects our commitment to deliver our full menu of precision diagnostic prostate cancer solutions, all of which are included in the NCCN Guidelines, to help improve the diagnosis and management of prostate cancer,” said Mdxhealth CEO Michael K. McGerrity in the news release.¹

Select mdx is a proprietary liquid biopsy mRNA test that assesses patients’ risk of clinically significant prostate cancer. The urine-based molecular test measures the expression of HOXC6 and DLX1, 2 mRNA cancer biomarkers, to determine whether a patient may benefit from prostate biopsy and earlier detection.

In 2020, the test was included in the NCCN guidelines for the early detection of prostate cancer.² Previous data on the urine-based assay supported its inclusion, including validation of the test in a multicenter study of 1955 men across the Netherlands, France, and Germany.³

For the study, levels of the HOXC6 and DLX1 biomarkers were measured via urine samples collected prior to initial biopsy. mRNA results were then combined in a clinical model with patient age, digital rectal examination, and prostate-specific antigen (PSA) density to calculate patient risk. Results from the model were compared with results from the Prostate Cancer Prevention Trial Risk Calculator (PCPTRC).

The study’s validation cohort included 916 men with a range of PSA levels. Among those patients, use of the test was associated with an area under the curve (AUC) of .85, 93% sensitivity, 47% specificity, and 95% negative predictive value. The PCPTRC yielded an AUC of .76.

Among patients with a PSA level less than 10 ng/mL, the test yielded an AUC of .82, 93% sensitivity, 47% specificity, and 95% negative predictive value. The PCPTRC yielded an AUC of .70.

Cigna’s coverage of the Select mdx test will take effect in Q4 of this year, joining other Mdxhealth diagnostic tests covered by the plan such as the Genomic Prostate Score (GPS) test and Confirm mdx.

References

1. Cigna expands commercial and Medicare Advantage coverage to include Mdxhealth’s Select mdx for prostate cancer test. News release. Mdxhealth. August 9, 2023. Accessed August 11, 2023. https://finance.yahoo.com/news/cigna-expands-commercial-medicare-advantage-200000158.html

2. Mdxhealth announces inclusion of Select mdx in 2020 NCCN guidelines for prostate cancer early detection. News release. Mdxhealth. July 27, 2020. Accessed August 11, 2023. https://mdxhealth.com/press_release/mdxhealth-r-6/

3. Haese A, Trooskens G, Steyaert S, et al. Multicenter optimization and validation of a 2-gene mRNA urine test for detection of clinically significant prostate cancer before initial prostate biopsy. J Urol. Published online July 8, 2019. Accessed August 11, 2023. doi:10.1097/JU.0000000000000293