(181 days)
Not Found
No
The device description explicitly states that the ROMA score is calculated using separate logistic regression equations for premenopausal and postmenopausal women. While logistic regression is a statistical method often used in machine learning, the description provides the fixed equations and cutoff points, indicating a predefined algorithm rather than a system that learns or adapts from data. There is no mention of training or inference phases typical of AI/ML systems.
No
This device is a diagnostic tool used to assess the likelihood of malignancy in ovarian adnexal masses, not to treat or alleviate a medical condition.
No
Explanation: The text explicitly states, "The test is not intended as a screening or stand-alone diagnostic assay." It also mentions, "RCTUEA should not be used without an independent clinical/ radiological evaluation." This indicates it's an aid in assessment, not a definitive diagnostic tool on its own.
No
The device description explicitly states that it combines the results of the Elecsys HE4 assay and Elecsys CA 125 II assay, which are electrochemiluminescence immunoassays intended for use on Elecsys and cobas e immunoassay analyzers. These are hardware components required for the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is a "qualitative test for serum and plasma" that combines results from other assays to aid in assessing the likelihood of malignancy. This involves testing biological samples (serum and plasma) in vitro (outside the body).
- Device Description: The description details how the device uses results from the Elecsys HE4 and Elecsys CA 125 II immunoassays, which are themselves described as "electrochemiluminescence immunoassay" for the quantitative determination of substances in human serum and plasma. Immunoassays performed on biological samples are a common type of IVD.
- Performance Studies: The performance studies describe evaluating the device's effectiveness using biological samples from patients (serum and plasma) and comparing the results to histopathology reports (which are also derived from biological samples).
- Predicate Device: The predicate device listed is "Fujirebio ROMA (HE4 EIA + ARCHITECT CA 125 IITM)", which is also an IVD used for a similar purpose.
The core function of the RCTUEA is to analyze data derived from in vitro tests performed on biological samples (serum and plasma) to provide information about a patient's condition. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ROMA Calculation Tool Using Elecsys Assays (RCTUEA) is a qualitative test for serum and plasma (K2-EDTA, K3-EDTA and Li-Heparin) that combines the results of the Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score.
RCTUEA is intended to aid in assessing whether a premenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. RCTUEA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. RCTUEA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
PRECAUTION: RCTUEA should not be used without an independent clinical/ radiological evaluation and is NOT intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of RCTUEA carries the risk of unnecessary testing, surgery and/or delayed diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
ONX
Device Description
ROMA Calculation Tool Using Elecsys Assays (RCTUEA) is a qualitative test for serum and plasma (K2-EDTA, K3-EDTA and Li-Heparin) that combines the results of the Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score. ROMA was developed using separate logistic regression equations for premenopausal and postmenopausal women:
Pre menopausal:
Predictive Index (PI) = - 12.0 + 2.38 x LN[HE4] + 0.0626 x LN[CA 125]
Post menopausal:
Predictive Index (PI) = - 8.09 + 1.04 x LN[HE4] + 0.732 x LN[CA 125]
RCTUEA value = exp (PI) / [1 + exp(PI)b)] x 10
RCTUEA is used to stratify women into likelihood groups for finding cancer on surgery. In order to provide a specificity level of 75 %, a cutoff point of ≥ 1.14 was used for premenopausal women and ≥ 2.99 was used for postmenopausal women who present with an ovarian adnexal mass. Women with RCTUEA results above these cutoff points are at high likelihood of finding malignancy on surgery.
The immunoassays used in RCTUEA are:
Elecsys HE4: an electrochemiluminescence immunoassay for the quantitative determination of HE4 in human serum and plasma
Elecsys CA 125 II: an electrochemiluminescence immunoassay for the quantitative determination of OC 125 reactive determinants in human serum and plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ovarian adnexal mass
Indicated Patient Age Range
over age 18
Intended User / Care Setting
Clinical and Hospital laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The effectiveness of RCTUEA was determined in a prospective, multi-center, blinded clinical trial for premenopausal and postmenopausal women presenting with an adnexal mass requiring surgical intervention.
A total of 455 women were evaluable in the study. For each patient, an initial cancer risk assessment (ICRA) was completed by a nurse practitioner, physician assistant or a non-gynecological oncologist who provided the assessment of the patient's mass as benign or malignant based on the information available during their work-up of the patient. The corresponding histopathology reports were collected after surgery.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective, multi-center, blinded clinical trial.
Sample Size: A total of 455 women were evaluable in the study (249 premenopausal, 206 postmenopausal).
Standalone performance:
Premenopausal women (N=237) for epithelial ovarian cancer (EOC):
- Sensitivity: 100% (9/9) (95% CI: 66.4% 100%)
- Specificity: 77.6% (177/228) (95% CI: 71.7% 82.9%)
- TP-FP: 77.6% (95% CI: 72.1% 83.2%)
- PPV: 15.0% (9/60) (95% CI: 7.1% 26.6%)
- NPV: 100.0% (177/177) (95% CI: 97.9% 100%)
- Prevalence: 3.8% (9/237)
Postmenopausal women (N=181) for epithelial ovarian cancer (EOC):
- Sensitivity: 89.5% (34/38) (95% CI: 75.2% 97.1%)
- Specificity: 82.5% (118/143) (95% CI: 75.3% 88.4%)
- TP-FP: 72.0% (95% CI: 60.2% 83.8%)
- PPV: 57.6% (34/59) (95% CI: 44.1% 70.4%)
- NPV: 96.7% (118/122) (95% CI: 91.8% 99.1%)
- Prevalence: 21.0% (38/181)
Adjunctive use of RCTUEA with Initial Cancer Risk Assessment (ICRA) for diagnosis of EOC including LMP:
- Sensitivity increased from 76.9% (ICRA) to 90.8% (ICRA and/or RCTUEA).
- Specificity decreased from 84.4% (ICRA) to 70.4% (ICRA and/or RCTUEA).
- PPV decreased from 46.3% (ICRA) to 34.9% (ICRA and/or RCTUEA).
- NPV increased from 95.4% (ICRA) to 97.8% (ICRA and/or RCTUEA). This observed increase in NPV was statistically significant, (P=0.0000) supporting the adjunctive use of RCTUEA with ICRA effective in ruling out cancer.
Key Results: RCTUEA stratifies women into high or low likelihood of finding malignancy on surgery, using cut-offs of ≥ 1.14 for premenopausal women and ≥ 2.99 for postmenopausal women to achieve a 75% specificity. The adjunctive use of RCTUEA with ICRA significantly increased NPV, indicating improved ability to rule out cancer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For premenopausal women with epithelial ovarian cancer (EOC):
- Sensitivity: 100% (9/9)
- Specificity: 77.6% (177/228)
- TP-FP: 77.6%
- PPV: 15.0% (9/60)
- NPV: 100.0% (177/177)
- Prevalence: 3.8% (9/237)
For postmenopausal women with epithelial ovarian cancer (EOC):
- Sensitivity: 89.5% (34/38)
- Specificity: 82.5% (118/143)
- TP-FP: 72.0%
- PPV: 57.6% (34/59)
- NPV: 96.7% (118/122)
- Prevalence: 21.0% (38/181)
For adjunctive use of RCTUEA with ICRA for Diagnosis of EOC including LMP:
- Sensitivity: 90.8% (59/65)
- Specificity: 70.4% (261/371)
- PPV: 34.9% (59/169)
- NPV: 97.8% (261/267)
- TP-FP: 61.1%
- PLRb: 3.06
- NLRc: 0.13
- Prevalence: 14.9% (65/436)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Fujirebio ROMA (K103358)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.6050 Ovarian adnexal mass assessment score test system.
(a)
Identification. An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test is for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery requires oncology expertise and resources.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” For the availability of this guidance document,see § 866.1(e).(c)
Black box warning. Under section 520(e) of the Federal Food, Drug, and Cosmetic Act these devices are subject to the following restriction: A warning statement must be placed in a black box and must appear in all advertising, labeling, and promotional material for these devices. That warning statement must read:
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2016
Roche Diagnostics Mr. Angelo Pereira Regulatory Affairs Program Manager 9115 Hague Road Indianapolis, IN 46250
Re: K153607
Trade/Device Name: Roma Calculation Tool Using Elecsys Assays Regulation Number: 21 CFR 866.6050 Regulation Name: Ovarian adnexal mass assessment score test system Regulatory Class: II Product Code: ONX Dated: May 13, 2016 Received: May 17, 2016
Dear Mr. Pereira:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kelly Oliner -S
For.
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153607
Device Name ROMA Calculation Tool Using Elecsys Assays
Indications for Use (Describe)
ROMA Calculation Tool Using Elecsys Assays (RCTUEA) is a qualitative test for serum and plasma (K2-EDTA, K3-EDTA and Li-Heparin) that combines the results of the Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score.
RCTUEA is intended to aid in assessing whether a premenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. RCTUEA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. RCTUEA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
PRECAUTION: RCTUEA should not be used without an independent clinical/ radiological evaluation and is NOT intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of RCTUEA carries the risk of unnecessary testing, surgery and/or delayed diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
4
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| | Address | Roche Diagnostics
9115 Hague Rd
Indianapolis, IN 46250 |
|--------------------------|--------------------|--------------------------------------------------------------|
| Submitter
Information | Contact Person | Angelo Pereira
angelo.pereira@roche.com |
| | Date prepared | June 06, 2016 |
| | | |
| Device Name | Proprietary names: | ROMA Calculation Tool Using Elecsys Assays |
| | Common names: | ROMA (Risk of Ovarian Malignancy Algorithm) |
| | Product Code: | ONX |
| | Predicate Device: | Fujirebio ROMA (K103358) |
| Establishment
Registration | For the ROMA Calculation Tool Using Elecsys Assays (RCTUEA), the
Elecsys HE4 assay and the Elecsys CA 125 II assay the establishment
registration numbers for Roche Diagnostics GmbH sites in Mannheim,
Germany and Penzberg, Germany are 9610126 and 9610529,
respectively. The establishment registration number for Roche
Diagnostics, Indianapolis, USA is 1823260 |
| ------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Classification The FDA has classified the Ovarian Adnexal Mass Assessment Score . Test as a Class II device.
| Panel | Product
Code | Classification Name | Regulation
Citation |
|------------|-----------------|------------------------------------------------------|------------------------|
| Immunology | ONX | Ovarian Adnexal Mass Assessment
Score Test System | 21 CFR 862.6050 |
5
Device ROMA Calculation Tool Using Elecsys Assays (RCTUEA) is a qualitative Description test for serum and plasma (K2-EDTA, K3-EDTA and Li-Heparin) that combines the results of the Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score. ROMA was developed using separate logistic regression equations for premenopausal and postmenopausal women:
Pre menopausal:
Predictive Index (PI) = - 12.0 + 2.38 x LN[HE4] + 0.0626 x LN[CA 125] Post menopausal:
Predictive Index (PI) = - 8.09 + 1.04 x LN[HE4] + 0.732 x LN[CA 125] RCTUEA value = exp (PI) / [1 + exp(PI)b)] x 10
RCTUEA is used to stratify women into likelihood groups for finding cancer on surgery. In order to provide a specificity level of 75 %, a cutoff point of ≥ 1.14 was used for premenopausal women and ≥ 2.99 was used for postmenopausal women who present with an ovarian adnexal mass. Women with RCTUEA results above these cutoff points are at high likelihood of finding malignancy on surgery.
The immunoassays used in RCTUEA are:
Elecsys HE4: an electrochemiluminescence immunoassay for the quantitative determination of HE4 in human serum and plasma
Elecsys CA 125 II: an electrochemiluminescence immunoassay for the quantitative determination of OC 125 reactive determinants in human serum and plasma.
6
| Intended
Use/
Indications
| for Use | ROMA Calculation Tool Using Elecsys Assays (RCTUEA) is a qualitative test for serum and plasma K2-EDTA, K3–EDTA and Li-Heparin) that combines the results of the Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score. RCTUEA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. RCTUEA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. RCTUEA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. |
|---|---|
| PRECAUTION: RCTUEA should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the RCTUEA calculation for use with the Elecsys HE4 and Elecsys CA 125 II assays carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. | |
| Substantial | |
| Equivalence | The ROMA Calculation Tool Using Elecsys Assays is substantially equivalent to Fujirebio's ROMA (HE4 EIA + ARCHITECT CA 125 IITM) (K103358). |
| Substantial | |
| Equivalence | |
| Comparison | The following table compares the ROMA Calculation Tool Using Elecsys Assays with the predicate device. |
| Continued on next page |
7
| Feature | Fujirebio ROMA | ROMA Calculation Tool Using
Elecsys Assays |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Assay Features | | |
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class II | Class II |
| Regulation Number | 21 CFR 866.6050 Ovarian adnexal
mass assessment score test system | 21 CFR 866.6050 Ovarian adnexal
mass assessment score test system |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Product Code | ONX | ONX |
| Panel | Immunology (82) | Immunology (82) |
| Intended Use/
Indications for Use | For In Vitro Diagnostic Use Only
The Risk of Ovarian Malignancy
Algorithm (ROMATM) is a
qualitative serum test that
combines the results of HE4 EIA,
ARCHITECT CA 125 IITM and
menopausal status into a numerical
score.
ROMA is intended to aid in
assessing whether a
premenopausal or postmenopausal
woman who presents with an
ovarian adnexal mass is at high or
low likelihood of finding
malignancy on surgery. ROMA is
indicated for women who meet the
following criteria: over age 18;
ovarian adnexal mass present for
which surgery is planned, and not
yet referred to an oncologist.
ROMA must be interpreted in
conjunction with an independent
clinical and radiological
assessment. The test is not
intended as a screening or stand-
alone diagnostic assay. | ROMA Calculation Tool Using
Elecsys Assays (RCTUEA) is a
qualitative test for serum and plasma
(K2EDTA, K3EDTA and LiHeparin)
that combines the results of the
Elecsys HE4 assay, Elecsys CA 125 II
assay and menopausal status into a
numerical score.
RCTUEA is intended to aid in
assessing whether a premenopausal or
postmenopausal woman who presents
with an ovarian adnexal mass is at
high or low likelihood of finding
malignancy on surgery. RCTUEA is
indicated for women who meet the
following criteria: over age 18;
ovarian adnexal mass present for
which surgery is planned, and not yet
referred to an oncologist. RCTUEA
must be interpreted in conjunction
with an independent clinical and
radiological assessment. The test is
not intended as a screening or stand-
alone diagnostic assay.
The electrochemiluminescence
immunoassay “ECLIA” is intended
for use on Elecsys and cobas e
immunoassay analyzers. |
| Assay Comparison | | |
| Feature | Fujirebio ROMA | ROMA Calculation Tool Using
Elecsys Assays |
| General Assay Features | | |
| Precautions
(ROMA) | Precaution: ROMA (HE4 EIA +
ARCHITECT CA 125 II should
not be used without an
independent clinical/radiological
evaluation and is NOT intended to
be a screening test or to determine
whether a patient should proceed
to surgery. Incorrect use of
ROMA (HE4 EIA + ARCHITECT
CA 125 II) carries the risk of
unnecessary testing, surgery,
and/or delayed diagnosis. | Precaution: RCTUEA should not be
used without an independent clinical
/radiological evaluation and is NOT
intended to be a screening test or to
determine whether a patient should
proceed to surgery. Incorrect use of
RCTUEA carries the risk of
unnecessary testing, surgery, and/or
delayed diagnosis. |
| Assay | Quantitative enzyme linked
immunosorbent assay | Both Elecsys HE4 and Elecsys CA
125 are quantitative sandwich
immunoassays |
| Analytes | HE4 and CA 125 II | HE4 and CA 125 II |
| Sample
types | Serum | Serum and plasma |
| Detection
Protocol | EIA (HE4) and CMIA (CA 125 II) | ECLIA for CA125 II and HE4 |
| Type of Test | Software algorithm and 2
immunoassays | Software algorithm and 2
immunoassays |
8
Continued on next page
9
Assessing the likelihood of malignancy assessment in women presenting with an adnexal mass who will undergo surgical intervention
RCTUEA takes into account the results of Elecsys HE4 and Elecsys CA 125 II as well as the menopausal status of woman. The RCTUEA value is used to aid in assessing whether a woman is at high or low likelihood of finding malignancy on surgery.
The effectiveness of RCTUEA was determined in a prospective, multi-center, blinded clinical trial for premenopausal and postmenopausal women presenting with an adnexal mass requiring surgical intervention.
A total of 455 women were evaluable in the study. For each patient, an initial cancer risk assessment (ICRA) was completed by a nurse practitioner, physician assistant or a non-gynecological oncologist who provided the assessment of the patient's mass as benign or malignant based on the information available during their work-up of the patient. The corresponding histopathology reports were collected after surgery. The histopathological classifications of the patients are given in the table below:
| All | Premenopausal | Postmenopausal | ||||
|---|---|---|---|---|---|---|
| Histopathological classification | N | % | N | % | N | % |
| Benign Pathology | 371 | 81.5 | 228 | 91.6 | 143 | 69.4 |
| Borderline/ LMP | 18 | 3.9 | 7 | 2.8 | 11 | 5.3 |
| Epithelial Ovarian Cancer | 47 | 10.3 | 9 | 3.6 | 38 | 18.4 |
| Non-Epithelial O. C. | 2 | 0.4 | 0 | 0 | 2 | 1.0 |
| Sex Cord Stroma | 2 | 0.4 | 0 | 0 | 2 | 1.0 |
| Other Gynecologic Cancer | 9 | 2.0 | 3 | 1.2 | 6 | 2.9 |
| Endometrial | 8 | 1.802 | 3 | 1.2 | 5 | 2.5 |
| Leiomyosarcoma | 1 | 1.5 | 0 | 0 | 1 | 0.4 |
| Other Cancer | 7 | 0.4 | 1 | 0.4 | 6 | 2.9 |
| Peritoneal Mesothelioma | 2 | 0.2 | 0 | 0 | 2 | 1.0 |
| Appendix | 1 | 0.2 | 1 | 0.4 | 0 | 0 |
| Carcinoid Tumor | 1 | 0.2 | 0 | 0 | 1 | 0.5 |
| Colon | 1 | 0.2 | 0 | 0 | 1 | 0.5 |
| Malignant Lymphoma | 1 | 0.2 | 0 | 0 | 1 | 0.5 |
| Pseudomyxoma Peritonel | 1 | 0.2 | 0 | 0 | 1 | 0.5 |
| Metastatic Cancer | 1 | 0.2 | 1 | 0.4 | 0 | 0 |
| Pancreatic | 1 | 0.2 | 1 | 0.4 | 0 | 0 |
| Total | 455 | 100 | 249 | 100 | 206 | 100 |
Histopathological classification of the multi-center study patients
Use of RCTUEA for stratification into low and high likelihood groups for finding malignancy on surgery
Using a preoperatively collected serum sample, RCTUEA was determined and the patient was stratified into a low or high likelihood group for finding malignancy on surgery. Samples were tested on the Elecsys e411 analyzer at three US testing sites.
The following cut-off points were used in order to provide a specificity level of 75%: Premenopausal women
10
RCTUEA values ≥ 1.14 = High likelihood of finding malignancy RCTUEA values