ExoDx PROSTATE TEST GRANTED EXPANDED COVERAGE BY MEDICARE

Rhea-AI Summary

Bio-Techne Corporation (NASDAQ: TECH) announced that the Medicare contractor, National Government Services, has finalized local coverage determination for the ExoDx Prostate Test. Effective March 1, 2023, this policy covers annual testing for men with a negative biopsy but considered at high risk for prostate cancer. The ExoDx Test helps identify patients who truly need invasive biopsies based on their PSA levels.

This updated coverage reflects the latest recommendations from the National Comprehensive Cancer Network, enhancing patient access to noninvasive testing before proceeding with biopsies, thus addressing rising prostate cancer incidences.

Positive

• Expanded coverage for ExoDx Prostate Test under Medicare supports more patients with high-risk profiles.
• Test is now recommended for men with a negative biopsy, improving patient care and potentially increasing company revenue.

Negative

• None.

Medicare contractor National Government Services finalizes local coverage determination for biomarker testing related to prostate cancer to include repeat biopsies and yearly testing

MINNEAPOLIS, Feb. 24, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that a newly finalized local coverage determination (LCD) from National Government Services, Inc., a Medicare Administrative Contractor, includes coverage for the ExoDx^™ Prostate Test from Exosome Diagnostics, a Bio-Techne brand. The updated policy now covers an annual ExoDx Prostate Test for men who already had a negative biopsy but are thought to be at high risk for prostate cancer and are considering a repeat biopsy. The coverage will go into effect March 1, 2023.

Prostate cancer is the most common type of cancer found in men. According to a recent report from the American Cancer Society, the incidence of prostate cancer is getting worse over the last decade. There is an increase in the number of cases diagnosed, as well as in the proportion of cases diagnosed at an advanced stage. Unfortunately, the ongoing challenge in the early detection and treatment of prostate cancer is the uncertainty about which patients do, and which patients do not need invasive biopsy procedures to look for the presence of cancer.

The noninvasive, urine-based ExoDx Prostate Test was designed to capture key molecular information to identify which men should undergo biopsies and which can safely be monitored with less invasive techniques. For patients whose prostate specific antigen (PSA) biomarker falls into a "gray zone" of uncertainty, the ExoDx Prostate Test offers critical information to distinguish between patients at risk of low-grade prostate cancer and those at risk of high-grade prostate cancer.

In the new local coverage determination, National Government Services included the ExoDx Prostate Test prior to a biopsy procedure for patients age 50 or older with a PSA higher than 4 ng/ml. It also covers the ExoDx Prostate Test for men who already had a negative biopsy but are thought to be at high risk and are considering a repeat biopsy. According to the new policy, the updates were based on recent changes to recommendations from the National Comprehensive Cancer Network (NCCN), which now includes the ExoDx Prostate Test on the list of tests that should be considered for patients thought to be at higher risk for aggressive prostate cancer despite previous negative biopsy results.

"We are very pleased that the ExoDx Prostate Test is now covered by Medicare for high-risk men with a prior negative biopsy that are considering a repeat biopsy. This important coverage determination ensures that more patients will have access to noninvasive testing before moving forward with painful, risky and potentially unnecessary biopsy procedures," said Kim Kelderman, President of the Diagnostics and Genomics Segment at Bio-Techne.

About Bio-Techne
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $1.1 billion in net sales in fiscal 2022 and has approximately 3,000 employees worldwide. For more information on Bio-Techne and its brands, please visit http://www.bio-techne.com. 

About Bio-Techne Corporation (NASDAQ: TECH)
Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com 
612-656-4416

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SOURCE Bio-Techne Corporation

FAQ

What is the ExoDx Prostate Test coverage update by Medicare?

Medicare has expanded coverage for the ExoDx Prostate Test to include annual testing for men with a negative biopsy but considered at high risk for prostate cancer, effective March 1, 2023.

How does the ExoDx Prostate Test benefit patients?

The ExoDx Prostate Test provides crucial information to determine if patients need invasive biopsies, helping to avoid unnecessary procedures.

When will the new Medicare coverage for the ExoDx Prostate Test take effect?

The expanded Medicare coverage for the ExoDx Prostate Test will take effect on March 1, 2023.

What is the significance of the local coverage determination for Bio-Techne's stock, symbol TECH?

The local coverage determination is likely to increase demand for Bio-Techne's ExoDx Prostate Test, positively impacting the company's revenue and stock performance.