Medical Policy

This document addresses the use of spectral analysis of prostate tissue by fluorescence spectroscopy, which involves using fiber optics to differentiate between normal prostate tissue and suspicious prostate tissue.

Note: Please see the following related document for additional information:

• CG-RAD-28 Transrectal Ultrasonography

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

Spectral analysis of prostate tissue by fluorescence spectroscopy is considered investigational and not medically necessary for all indications.

This document describes clinical studies and expert recommendations, and explains whether spectral analysis of prostate tissue by fluorescence spectroscopy is appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Spectral analysis of prostate tissue by fluorescence spectroscopy is a method that uses light and special sensors to help doctors see differences between normal and possibly cancerous prostate tissue. The goal is to guide where to take tissue samples (called biopsies) and possibly make cancer detection more accurate. This test uses a tool called the ClariCore™ Biopsy System, which shines light into the tissue and analyzes the reflected light to suggest where a biopsy might find cancer. While this test is being studied, it does not yet have approval from the U.S. Food and Drug Administration (FDA). Early research has shown it may have some promise, but there is not enough evidence to know if it helps people live longer or stay healthier. Each year, prostate cancer affects many people, and researchers are looking for better ways to find and treat it. However, not all new technologies are proven to work well or safely.

What the Studies Show

A small study in 2015 tested this method in 13 men with prostate cancer. During surgery to remove the prostate, doctors used the device to collect tissue samples and analyze light signals from those areas. They compared this information to traditional lab results to see if the test could correctly identify cancer. The test correctly found cancer in about three out of four cases, and it was more likely to miss cancer than to falsely say it was there. While this sounds helpful, the study had only a few participants and was meant mainly to test if the method could work at all. Larger, high-quality studies are still needed to know if this test improves people’s health in real life. Using a test that is not proven can lead to needless worry or treatment that does not help.

Is this clinically appropriate?

This test is not appropriate because it has not been proven to improve health. Early studies show it may help identify cancer during surgery, but better studies are needed to confirm this. There is no FDA approval yet, and experts agree that more research is necessary before it can be recommended for routine use.

(Return to Description/Scope)

Summary

This document reviews the use of spectral analysis of prostate tissue by fluorescence spectroscopy, a technique that uses fiber optics and predictive algorithms to distinguish between normal and suspicious prostate tissue and potentially guide prostate biopsy procedures. Despite its proposed benefit of improving biopsy yield, this technology is currently considered investigational and not medically necessary for all indications. The ClariCore Biopsy System is one such device, but it does not yet have U.S. Food and Drug Administration approval, and clinical trials are still ongoing.

Evidence to date is limited, with a small 2015 feasibility study showing moderate sensitivity and specificity in distinguishing malignant from benign tissue in both in vivo and ex vivo settings during radical prostatectomy. While the results suggest potential clinical application, the study involved a small sample size and was not designed to demonstrate improved patient outcomes. Given the high prevalence and mortality associated with prostate cancer, further large-scale, well-designed studies are needed to determine whether fluorescence spectroscopy meaningfully improves diagnostic accuracy and net health outcomes.

Discussion

Spectral analysis of prostate tissue by fluorescence spectroscopy has been proposed as a method to improve yield of tissue biopsies taken from the prostate. This system uses a predictive algorithm to perform spectral analysis of reflected light to distinguish between normal and suspicious tissue which can then help guide prostate biopsy procedures.

A 2015 feasibility study was reported by Werahera and colleagues. In this study, 13 participants with prostate cancer who were scheduled to undergo radical prostatectomy also consented to have analysis of prostate tissue by fluorescence spectroscopy during the prostatectomy. The primary objective was to evaluate the safety and effectiveness of the optical biopsy needle to acquire spectral data and correlative tissue biopsy cores for real-time diagnosis of prostate cancer in clinical settings. The in vivo optical biopsies were performed during the radical prostatectomy and multiple biopsy core samples and correlative spectral data were obtained from each participant within a 10-minute time period. Following radical prostatectomy, ex vivo biopsy core samples and spectral data were also obtained from each surgically excised prostate within a 90-minute time period. The spectral data and corresponding tissue biopsy cores were obtained from different locations within each prostate specimen. The biopsy cores were classified as either benign or malignant and then correlated with the corresponding spectral data. In the in vivo samples, histopathological analysis found cancer in 29/208 viable biopsy cores and in the ex vivo samples, cancer was reported in 51/224 viable biopsy cores. For the in vivo samples there was 72% sensitivity, 66% specificity, and 93% negative predictive value. For the ex vivo samples there was 75% sensitivity, 80% specificity, and 93% negative predictive value in malignant versus benign prostatic tissue classification. The study shows a potential clinical application of spectral analysis of prostate tissue by fluorescence spectroscopy, however additional studies are necessary to assess improved net health outcomes.

Clinical trials are in progress to collect information on prostate biopsy tissue using fluorescence spectroscopy during radical prostatectomy surgery. At this time, the device does not have United States Food and Drug Administration approval.

Prostate cancer is the most commonly diagnosed cancer, other than skin cancers, in North American men. According to the American Cancer Society (ACS), in 2025 there will be an estimated 313,780 new cases of prostate cancer and 35,770 deaths. Prostate cancer is the second leading cause of cancer death in American men, exceeded only by lung cancer. Men in the United States have about 1 chance in 8 of eventually being diagnosed with this malignancy and about 1 man in 44 will eventually die of the disease (ACS, 2025).

The ClariCore^™ Biopsy System (Precision Biopsy^™, Aurora, CO) is the device for collecting prostate biopsy tissue using fluorescence spectroscopy. According to the manufacturer’s website, the ClariCore system has been licensed by another manufacturer (PreView Medical, Inc., Longmont, CO).

Biopsy: The removal of a sample of tissue for examination under a microscope for diagnostic purposes.

Prostate: A walnut-shaped gland in men that extends around the urethra at the neck of the urinary bladder and supplies fluid that goes into semen.

Radical prostatectomy: Surgical procedure for the removal of the prostate.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure code or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Werahera PN, Jasion EA, Crawford ED, et al. Systematic diagnosis of prostate cancer using an optical biopsy needle adjunct with fluorescence spectroscopy. Conf Proc IEEE Eng Med Biol Soc. 2014; 2014:2165-2168.
2. Werahera PN, Jasion EA, Liu Y, et al. Human feasibility study of fluorescence spectroscopy guided optical biopsy needle for prostate cancer diagnosis. Conf Proc IEEE Eng Med Biol Soc. 2015; 2015:7358-7361.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Precision Biopsy, Inc. ClariCore Biopsy System in patients undergoing radical retropubic prostatectomy. NLM Identifier: NCT02773940. Last updated on February 15, 2019. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02773940?term=claricore&rank=1. Accessed on February 13, 2026.
2. Precision Biopsy, Inc. ClariCore Optical Biopsy System used in TRUS (trans-rectal ultrasound)-guided prostrate biopsy. NLM Identifier: NCT02928640. Last updated on February 15, 2019. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02928640?term=claricore&rank=2. Accessed on February 13, 2026.

1. American Cancer Society (ACS). Prostate cancer. Available at: https://www.cancer.org/cancer/prostate-cancer.html. Accessed on February 13, 2026.
2. National Cancer Institute (NCI). Cancer Types. Available at: http://www.cancer.gov/cancertopics/types/alphalist. Accessed on February 13, 2026.

ClariCore Biopsy System
Prostate cancer
Prostatectomy

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