Summary & Overview

CPT 0577U: GlycoKnow Ovarian 39-Glycoprotein Ovarian Cancer Risk Panel

CPT code 0577U designates the GlycoKnow™ Ovarian proprietary laboratory assay from InterVenn Biosciences, a serum-based 39-glycoprotein panel that produces a malignancy risk score for ovarian cancer using LC–MS/MS in multiple reaction monitoring mode. As a PLA code, 0577U is unique to a single manufacturer's test and signals the test’s proprietary nature to payers and billing systems. Nationally, PLA codes like 0577U matter because they affect coverage determinations, coding clarity, and claims adjudication for specialized diagnostics used in cancer risk assessment.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context and testing methodology, a summary of typical sites of service and service type, and the payer landscape addressed in the analysis. The publication summarizes benchmarking and policy-relevant considerations surrounding PLA-coded diagnostics, including implications for coverage policies, claim submission, and clinical utilization. Data not available in the input is noted where applicable, and the content focuses on national implications rather than state-specific policy.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0577UCPTProprietary Laboratory AnalysisGlycoprotein PanelOvarian Cancer RiskLC-MS/MSLaboratory DiagnosticsProprietary Test

Billing Code Overview

CPT code 0577U is a Proprietary Laboratory Analyses (PLA) code assigned exclusively to the GlycoKnow™ Ovarian test from InterVenn Biosciences. The assay evaluates the likelihood of ovarian cancer by measuring 39 glycoproteins in a serum sample and generating a malignancy risk score using liquid chromatography with tandem mass spectrometry (LC–MS/MS) in multiple reaction monitoring mode.

Service Type: Laboratory molecular/biochemical diagnostic test (proprietary PLA)

Typical Site of Service: Clinical laboratory or reference laboratory; specimen collection may occur in outpatient clinics or phlebotomy sites.

Clinical & Coding Specifications

Clinical Context

A 58-year-old woman with a pelvic mass noted on ultrasound and persistent adnexal fullness presents to a gynecologic oncology clinic for evaluation. Her clinician suspects possible epithelial ovarian malignancy but needs further noninvasive risk stratification prior to recommending surgery. A serum sample is collected during the clinic visit or at an outpatient laboratory; the sample is sent to InterVenn Biosciences for the GlycoKnow™ Ovarian test. The laboratory performs liquid chromatography–tandem mass spectrometry (LC–MS/MS) in multiple reaction monitoring mode to measure 39 glycoproteins and generates a malignancy risk score. Results are returned to the ordering clinician and used alongside imaging, CA-125, and clinical findings to inform referral, preoperative planning, and discussion of likelihood of malignancy. Typical site of service is outpatient clinic, physician office, or outpatient phlebotomy/laboratory collection facility. Service type: Proprietary laboratory analysis (PLA) — specialty laboratory molecular diagnostic testing.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier; standard reporting	Used when no special circumstance modifier applies and the test is reported as usual.
`22`	Increased procedural services	Used when work for the test required substantially greater resources or work effort beyond typical (rare for PLA codes; apply per payer policy).
`52`	Reduced services	Used when specimen or assay was performed with reduced components or partial testing that yields a limited report.
`53`	Discontinued procedure	Used if testing was begun but discontinued for clinical reasons prior to completion; rarely applicable to send-out PLA tests.
`26`	Professional component	Use when separating professional interpretation component from technical services, if payer requires split billing (may be uncommon for PLA codes).
`TC`	Technical component	Use when billing only the technical component (laboratory processing) and the ordering clinician retains no professional interpretation billing.
`QW`	CLIA waived test (not typical)	Not applicable to PLA LC–MS/MS, included for payer contexts that track CLIA status; do not use if test is not CLIA waived.
`90`	Reference (outside) laboratory	Use when a billing provider is reporting testing performed by a different laboratory and local payer requires this modifier for pass-through billing.
`91`	Repeat clinical diagnostic laboratory test	Use when the same test is repeated on the same day for verification of results per payer rules.
`99`	Multiple modifiers (other)	Use to indicate multiple modifiers are present when payer requires a specific indicator rather than listing each one.

Taxonomy Code	Specialty	Notes
207V00000X	Obstetrics & Gynecology	Ordering clinicians commonly include OB/GYNs evaluating adnexal masses.
207L00000X	Gynecologic Oncology	Gynecologic oncologists order advanced ovarian cancer risk assays for preoperative planning.
208000000X	Hematology & Medical Oncology	Medical oncologists may order testing when systemic malignancy is suspected or for treatment planning.
208D00000X	Pathology	Pathologists or clinical laboratory directors may oversee test interpretation or lab coordination.
363L00000X	Clinical Laboratory	Clinical laboratory specialists and molecular diagnostics labs perform specimen processing and testing.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`N83.2`	Torsion of ovary, ovarian pedicle	Ovarian torsion may present with adnexal mass; testing sometimes used in differential when malignancy risk is considered.
`N83.1`	Follicular cyst of ovary	Common benign adnexal lesion; assay may help distinguish benign from malignant processes.
`N84.1`	Polyp of corpus uteri	Benign uterine pathology that can coexist with adnexal findings; included as part of pelvic workup differential.
`C56.9`	Malignant neoplasm of ovary, unspecified	Primary diagnosis when malignancy is suspected; the assay evaluates likelihood of ovarian cancer.
`R19.0`	Intra-abdominal and pelvic swelling, mass and lump	Non-specific code for pelvic mass prompting further evaluation with serum biomarkers including glycoprotein assays.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Commonly performed immediately prior to sending serum for the GlycoKnow™ Ovarian test.
`80053`	Comprehensive metabolic panel (CMP)	Frequently ordered in the same workup to assess baseline organ function prior to surgery; complementary laboratory evaluation.
`86304`	Immunoassay for tumor antigen, quantitative; CA 125	Often ordered alongside glycoprotein-based risk assessments as a comparative or adjunct tumor marker.
`88305`	Level IV surgical pathology, gross and microscopic examination	Performed if surgery proceeds and tissue is obtained to establish definitive histologic diagnosis following risk stratification.
`CPT 0577U`	GlycoKnow™ Ovarian (Proprietary Laboratory Analyses code)	The PLA code used to report the specific GlycoKnow™ Ovarian LC–MS/MS glycoprotein assay that generates a malignancy risk score.