CPT 0609U: ClarityDX Prostate PSA Immunoassay Algorithm Score

CPT code 0609U is a Proprietary Laboratory Analyses (PLA) code reported only for ClarityDX Prostate from Protean BioDiagnostics and Nanostics Inc; it describes an immunoassay-based laboratory test that measures total and free prostate-specific antigen (PSA) in serum or plasma and combines those results with clinical information to produce an algorithm-based probability score for clinically significant prostate cancer, categorized as a laboratory-developed diagnostic service typically performed in a clinical laboratory or reference lab setting.

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CPT 0609U: ClarityDX Prostate PSA Immunoassay Algorithm Score

Customize your policy alerts

Sign up for cpt 0609U policy alerts

Get alerted when payer policies referencing 0609U are released or updated.

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Receive email alerts as soon as relevant payer policies are published or updated.

Clinical & Coding Specifications

Clinical Context

A 62-year-old man with a history of rising prostate-specific antigen (PSA) values and an equivocal digital rectal exam presents for further risk stratification. His urologist orders the proprietary blood-based test 0609U (ClarityDX Prostate) to measure total and free PSA by immunoassay and to generate an algorithm-based probability score for clinically significant prostate cancer. Blood is drawn in an outpatient clinic or ambulatory lab; serum or plasma specimens are sent to the performing laboratory (Protean BioDiagnostics/Nanostics Inc.) under appropriate chain-of-custody and handling instructions. The laboratory performs the immunoassays, combines the assay results with the supplied clinical variables (for example age, prior biopsy history, family history), and reports a probability score to guide shared decision-making about the need for prostate biopsy, imaging, or continued surveillance. Typical sites of service include outpatient clinic, ambulatory surgical center laboratory draw station, or independent clinical laboratory where venipuncture and specimen transport occur.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0512U`	Measurement of circulating tumor DNA or other proprietary molecular test (example PLA)	Other proprietary laboratory analyses (PLAs) that may be ordered in parallel for prostate cancer risk or molecular profiling; shown as an example of accompanying specialized assays.
`81002`	Urinalysis, non-automated, without microscopy	Pre-test or concurrent urinalysis may be performed to rule out urinary infection before biopsy decisions informed by `0609U`.
`81025`	Urine pregnancy test, by visual color comparison methods (for female patients)	Not typical for male prostate testing; included only when required by institutional pre-analytic workflows in mixed populations.
`36415`	Collection of venous blood by venipuncture	Commonly performed at the drawing site to obtain serum or plasma for `0609U` testing.
`88305`	Level IV surgical pathology, gross and microscopic examination	If the `0609U` result leads to prostate biopsy, pathology coding for biopsy specimens would include codes like `88305`.
`76872`	Transrectal ultrasound, prostate, with biopsy guidance	Performed when a high probability score from `0609U` prompts image-guided prostate biopsy.

Related Modifiers

5 rows

Modifier	Description	When to Use
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
59	Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…	- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
91	Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…	- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…
[object Object]
73	Modifier 73 indicates a facility-level outpatient hospital or ASC procedure that was discontinued after the patient was prepared and taken to the procedure/operating room but before any anesthesia…	- When to use: Apply CPT modifier 73 on the FACILITY (outpatient hospital or ASC) claim when the patient has been fully prepared and physically taken into the procedure/operating room but the…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
207L00000X	Anesthesiology Physician	An anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
208000000X	Pediatrics Physician	A pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
1835P2201X	Ambulatory Care Pharmacist	A licensed pharmacist who has demonstrated specialized knowledge and skill in the provision of integrated, accessible health care services by pharmaci…
207RR0500X	Rheumatology Physician	An internist who treats diseases of joints, muscle, bones and tendons. This specialist diagnoses and treats arthritis, back pain, muscle strains, comm…
111NN1001X	Nutrition Chiropractor	Chiropractic Nutrition is that specialty within the chiropractic profession that deals with the overall factors that affect the patient's ability to m…
173F00000X	Sleep Specialist (PhD)	Sleep medicine is a clinical specialty with a focus on clinical problems that require accurate diagnosis and treatment. The knowledge base of sleep me…
246Z00000X	Other Specialist/Technologist	General classification identifying individuals trained on specific equipment and technical procedures in one of a collection of miscellaneous healthca…

CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

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Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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Clinical & Coding Specifications

Clinical Context

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0512U`	Measurement of circulating tumor DNA or other proprietary molecular test (example PLA)	Other proprietary laboratory analyses (PLAs) that may be ordered in parallel for prostate cancer risk or molecular profiling; shown as an example of accompanying specialized assays.
`81002`	Urinalysis, non-automated, without microscopy	Pre-test or concurrent urinalysis may be performed to rule out urinary infection before biopsy decisions informed by `0609U`.
`81025`	Urine pregnancy test, by visual color comparison methods (for female patients)	Not typical for male prostate testing; included only when required by institutional pre-analytic workflows in mixed populations.
`36415`	Collection of venous blood by venipuncture	Commonly performed at the drawing site to obtain serum or plasma for `0609U` testing.
`88305`	Level IV surgical pathology, gross and microscopic examination	If the `0609U` result leads to prostate biopsy, pathology coding for biopsy specimens would include codes like `88305`.
`76872`	Transrectal ultrasound, prostate, with biopsy guidance	Performed when a high probability score from `0609U` prompts image-guided prostate biopsy.

Related Modifiers

5 rows

Modifier	Description	When to Use
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
59	Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…	- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
91	Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…	- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…
[object Object]
73	Modifier 73 indicates a facility-level outpatient hospital or ASC procedure that was discontinued after the patient was prepared and taken to the procedure/operating room but before any anesthesia…	- When to use: Apply CPT modifier 73 on the FACILITY (outpatient hospital or ASC) claim when the patient has been fully prepared and physically taken into the procedure/operating room but the…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
207L00000X	Anesthesiology Physician	An anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
208000000X	Pediatrics Physician	A pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
1835P2201X	Ambulatory Care Pharmacist	A licensed pharmacist who has demonstrated specialized knowledge and skill in the provision of integrated, accessible health care services by pharmaci…
207RR0500X	Rheumatology Physician	An internist who treats diseases of joints, muscle, bones and tendons. This specialist diagnoses and treats arthritis, back pain, muscle strains, comm…
111NN1001X	Nutrition Chiropractor	Chiropractic Nutrition is that specialty within the chiropractic profession that deals with the overall factors that affect the patient's ability to m…
173F00000X	Sleep Specialist (PhD)	Sleep medicine is a clinical specialty with a focus on clinical problems that require accurate diagnosis and treatment. The knowledge base of sleep me…
246Z00000X	Other Specialist/Technologist	General classification identifying individuals trained on specific equipment and technical procedures in one of a collection of miscellaneous healthca…

CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

Published by

Trek Health powers OpenPayer with a leading commercial payer intelligence platform, seamlessly converting fragmented payer data into actionable insights for provider organizations.

OpenPayer

CPT 0609U: ClarityDX Prostate PSA Immunoassay Algorithm Score

Sign up for cpt 0609U policy alerts

OpenPayer

CPT 0609U: ClarityDX Prostate PSA Immunoassay Algorithm Score

Sign up for cpt 0609U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

References

CPT 0609U: ClarityDX Prostate PSA Immunoassay Algorithm Score

Sign up for cpt 0609U policy alerts

CPT 0609U: ClarityDX Prostate PSA Immunoassay Algorithm Score

Sign up for cpt 0609U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

What does CPT 0609U represent and which laboratory test does it apply to?

What specimen type and site of service are typical for 0609U, and where is the testing performed?

What related CPT codes or services are commonly associated with ordering or following 0609U?

Which ICD-10 diagnosis codes are relevant when ordering 0609U?

What clinical purpose does the 0609U result serve and does the page provide reimbursement amounts or policy guidance?

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

What does CPT 0609U represent and which laboratory test does it apply to?

What specimen type and site of service are typical for 0609U, and where is the testing performed?

What related CPT codes or services are commonly associated with ordering or following 0609U?

Which ICD-10 diagnosis codes are relevant when ordering 0609U?

What clinical purpose does the 0609U result serve and does the page provide reimbursement amounts or policy guidance?

References