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

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· Murphy AB, Abern MR, Liu L, Wang H, Hollowell CMP, Sharifi R, Vidal P, et al. Impact of a Genomic Test on Treatment Decision in a Predominantly African American Population With Favorable-Risk Prostate Cancer: A Randomized Trial. J Clin Oncol. 2021;39(15):1660-1670.

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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 SelectMDx test for prostate cancer? ›

SelectMDx is a urine-based test based on prostate cancer genomic biomarkers HOXC6 and DLX1, which together have a 76% sensitivity (reliability) for detecting a prostate cancer that is aggressive enough (Gleason score of 7 or greater) to require treatment.

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 MDX testing? ›

SelectMDx is a urine-based test which helps determine your risk of aggressive prostate cancer, and whether a biopsy may be necessary.

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 accurate 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 is the quick test for prostate cancer? ›

The PSA test is a blood test to help detect prostate cancer. But it's not perfect and will not find all prostate cancers. The test, which can be done at a GP surgery, measures the level of prostate-specific antigen (PSA) in your blood. PSA is a protein made only by the prostate gland.

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.

Why do you need an MRI before a prostate biopsy? ›

You get an MRI first to help your provider identify any suspicious areas on your prostate gland. During the actual biopsy, your provider uses a prostate ultrasound probe and advanced software to combine the MRI and ultrasound images.

Is SelectMDx FDA approved? ›

The SelectMDx for Prostate Cancer test was developed, and its performance characteristics determined by MDxHealth. It has not been reviewed by the U.S. Food and Drug Administration. The FDA has determined such clearance or approval is not necessary.

What is normal PSA for a 60 year old man? ›

For men in their 40s and 50s: A PSA score greater than 2.5 ng/ml is considered abnormal. The median PSA for this age range is 0.6 to 0.7 ng/ml. For men in their 60s: A PSA score greater than 4.0 ng/ml is considered abnormal. The normal range is between 1.0 and 1.5 ng/ml.

What is the my prostate score test? ›

MPS2 is a urine test designed to predict the presence of clinically significant prostate cancer (Grade Group ≥2 or Gleason score ≥7) by analyzing a comprehensive array of 18 unique gene transcripts. Among the transcripts, the test's foundation is the novel gene fusion, T2:ERG.

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 specificity of PSMA sensitivity? ›

A recent template-based analysis study including 130 patients revealed that the sensitivity, specificity and accuracy of PSMA PET were 68.3%, 99.1% and 95.2%, respectively, while for morphological imaging the sensitivity, specificity and accuracy were 27.3%, 97.1% and 87.6%, respectively 13.

What is the difference between sensitivity and specificity? ›

Sensitivity refers to a test's ability to designate an individual with disease as positive. A highly sensitive test means that there are few false negative results, and thus fewer cases of disease are missed. The specificity of a test is its ability to designate an individual who does not have a disease as negative.

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 is the test of choice for diagnosing prostate cancer? ›

A core needle biopsy is the main method used to diagnose prostate cancer. It is usually done by a urologist. During the biopsy, the doctor usually looks at the prostate with an imaging test, such as transrectal ultrasound (TRUS) or MRI, or a 'fusion' of the two (all discussed below).

What is the score on the ExoDx prostate test? ›

The ExoDx Prostate Test, or EPI is a risk assessment tool. A score below 15.6 indicates a lower risk of high-grade prostate cancer (≥GG2) with a sensitivity of 92.0% and a negative predictive value (NPV) of 91.3%. A score above 15.6 indicates an increasing risk of high-grade prostate cancer.

What is the single blood test for prostate cancer? ›

What is the PSA test? Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in the blood. For this test, a blood sample is sent to a laboratory for analysis.

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