Palmetto GBA’s MolDX Issues Foundational LCD Covering the Indication for SelectMDx for Prostate Cancer - mdxhealth (2024)

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Palmetto GBA’s MolDX Issues Foundational LCD Covering the Indication for SelectMDx for Prostate Cancer - mdxhealth (2024)

FAQs

What is the MDX test for prostate cancer? ›

SelectMDx is a simple urine biomarker test that has an accuracy of 98% for detecting significant (Gleason 3+4 and higher) prostate cancers, outperforming other urine markers such as PCA3. It is a genomic classifier test, meaning that it tests the genes of the patient for signs of prostate cancer.

When to use SelectMDx? ›

If you learn that your PSA level is abnormal and/or that you have other clinical risk factors (age, increased prostate volume, family history of prostate cancer, abnormal DRE result) for prostate cancer, talk to your urologist about ordering the Select mdx test—before having a prostate biopsy.

What is confirm mdx? ›

The Confirm mdx test will help to determine if you are at risk for undetected prostate cancer. The test examines your biopsy tissue at a DNA level to detect cancer-related changes that cannot be seen during a standard microscopic evaluation.

What is the sensitivity and specificity of SelectMDx? ›

Pooled analysis of findings found an area under the receiver operating characteristic analysis curve of 70% [95% CI, 66%-74%], a sensitivity of 81% [95% CI, 69%-89%], and a specificity of 52% [95% CI, 41%-63%]. The positive likelihood ratio was 1.68, and the negative predictive value is 0.37.

What is the most reliable test for prostate cancer? ›

A prostate biopsy is one of the most accurate ways to diagnose prostate cancer. But because it is an invasive procedure, other screening methods are used first. Some tests may be carried out by your GP when you first go to them with concerns.

What PSA level usually indicates prostate cancer? ›

There is no specific normal or abnormal level of PSA in the blood. In the past, PSA levels of 4.0 ng/mL and lower were considered normal. However, some individuals with PSA levels below 4.0 ng/mL have prostate cancer and many with higher PSA levels between 4 and 10 ng/mL do not have prostate cancer (1).

What is the Prolaris prostate test? ›

Prolaris is a genomic test that analyzes changes in 46 genes in prostate biopsy tissue. It generates a risk score to help predict the likelihood of disease progression in men with localized prostate cancer.

Is ConfirmMDX fda approved? ›

ConfirmMDX is not yet FDA approved but is in use as a supplement to traditional diagnostic such as a biopsy.

How accurate is the confirm MDX test? ›

The ConfirmMDx test has an AUC of . 76, meaning it has a good predictive ability to predict if there is cancer in an area based on the hypermethylated tissue. The 95% confidence interval of . 67-.

What is the negative predictive value of select MDX? ›

The test's negative predictive value (NPV) is 95%, meaning if the test identifies a very low risk, the physician and patient can be 95% sure the patient does not have Gleason score ≥7 (GS≥7) prostate cancer and avoid a biopsy.

How SelectMDx impacts prostate biopsy decision making in routine clinical practice? ›

In this study, SelectMDx had a significant impact on initial prostate biopsy decision-making in a U.S. community urology setting. Biopsy rates in SelectMDx positive men were 5-fold higher than in SelectMDx negatives.

What are the three tests for prostate cancer? ›

Tests for prostate cancer
  • a digital rectal examination.
  • a PSA blood test.
  • scans.
  • taking a sample of your prostate gland called a biopsy.
Apr 7, 2022

What does MDX Health do? ›

Mdxhealth is a commercial-stage precision diagnostics company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of prostate cancer and other urologic diseases. The Company's tests are based on proprietary genetic, epigenetic and other complex molecular technologies.

What is a PSMA test for prostate cancer? ›

FDA approved imaging technique for prostate cancer.

The PSMA PET scan can identifiy cancer that is often missed by current standard-of-care imaging techniques. The PSMA tracer can also be used in conjunction with CT or MRI scans. UCSF is only one of two medical centers in the U.S. that offers the FDA approved PSMA PET.

What is the GPS score for prostate cancer? ›

GPS + NCCN Individualized Risk:

The score ranges from 0-100 (with scores closer to zero representing lower risk prostate cancer disease potential and those closer to 100 representing higher risk prostate cancer disease potential.

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