A simple blood test to aid in the early detection of ovarian cancer.

NEW!
A simple blood test to aid in the
early detection of ovarian cancer.
F o r A n n u a l Wo m e n’ s H e a l t h E x a m s
The ROCA® Test
R I S K O F OVA R I A N C A N C E R A LG O R I T H M
The ROCA Test is the first step in detecting ovarian cancer in asymptomatic women,
where an abnormal result indicates the need for a transvaginal ultrasound.
How the ROCA® Test Works
A woman’s baseline risk is determined by her
age, menopausal status, genetic mutations
and family history of ovarian and/or breast
cancer.
Baseline Risk Profile
• Age
• Menopausal Status
• Risk factors for ovarian cancer
FLAT PROFILES
Serial CA-125
Women without
ovarian cancer
RISING PROFILES
Women with
ovarian cancer
The ROCA Test adjusts the patient’s baseline
risk by comparing her unique serial CA-125
profile to similar risk profiles of women with
or without ovarian cancer.
CA-125 U/ml
CA-125 FLAT PROFILE = NO CANCER
Compared to
Serial CA-125
profiles of thousands
of women
ROCA Tests
CA-125 U/ml
CA-125 RISING PROFILE = CANCER
ROCA Tests
ROCA Test Result
Normal
Elevated
The ROCA Test result is then classified as
normal, intermediate or elevated. Approximately 90% of women are expected to
receive a test result that is normal. 2
Intermediate
The ROCA Test has been shown to detect TWICE as many
ovarian cancers than the CA-125 35U/mL fixed cut-off. 2
Validation of High Performance
UK Collaborative Trial
of Ovarian Cancer Screening (UKCTOCS)1,2,3
One arm of this 15 year randomized controlled trial investigated the use of the ROCA Test,
as the first step in a multimodal strategy (MMS), with a subsequent transvaginal ultrasound
to detect ovarian cancer in asymptomatic postmenopausal women between 50 and 74 years old.
Most accurate ovarian cancer test 1,2,3
20.8%
85.8%
99.8%
85.8% of cancer can be
detected with the ROCA Test,
usually before symptoms appear
With a false positive rate of .2%,
women without ovarian cancer
are accurately identified*
Sensitivity
Positive Predictive Value
Specificity
Minimal harm to patients, with
1 ovarian cancer detected for
every 5 surgeries◊
* Specificity is based on a multimodal strategy where the ROCA Test is the first step and transvaginal ultrasound is the second.
◊Additionally, benign tumors, other ovarian neoplasms or non-ovarian malignancies were identified in 58% of surgeries
Detects more ovarian cancers at an earlier stage 1,2,3
Percent of Stage I/II
Ovarian Cancers Detected
by The ROCA Test
Women diagnosed with ovarian cancer,
identified by the ROCA Test
100
90
80
70
60
40
50
48.6%
33.3%
40
30
➜
20
10
2003
2005
2007
2009
2011
30
20
10
Figure 1
The ROCA Test identifies women with ovarian cancer
when CA-125 is less than 35 U/mL, detecting more
ovarian cancer at an earlier stage.
Figure 1. The dots represent the CA-125 levels of women with invasive epithelial ovarian and/
or tubal cancers, when the ROCA Test was abnormal for the first time. The 70 green dots are
ovarian cancer cases detected when the CA-125 was in the normal range, below 35 U/mL.
Figure 2. The Percentage of stage I/II ovarian cancers detected by the ROCA Test, classified by
levels of CA-125 (< or > 35U/ml), represented by the dots in Figure 1.
CA-125 <35U/ml
CA-125 U/mL
50
CA-125 >35U/ml
➜
60
0
Figure 2
48.6% of the ovarian cancers
detected by the ROCA Test, when
the CA-125 value is less than
35U/mL, are stage I and stage II.
No other test
detects ovarian cancer
1, 2, 3
earlier or more accurately.
The ROCA Test is for:
Postmenopausal Women (<10% Lifetime Risk of Ovarian Cancer)
Patients between 50 and 85 years and are postmenopausal
Recommended Frequency of ROCA Testing with Normal Results: 1 x per year
High Risk Women (≥10% Lifetime Risk of Ovarian Cancer)
Patients between 35 and 85 years with either a family history of ovarian and/
or breast cancer and/or have tested positively for BRCA1, BRCA2 or Lynch
syndrome gene mutations
Recommended Frequency of ROCA Testing with Normal Results: 3 x per year
with an annual TVU
For more information:
www.rocatest.com/physicians
Phone: 844.258.1079
Email: [email protected]
References:
1. Menon U, Gentry-Maharaj A, Hallett R, et al: Sensitivity and specificity of multimodal and ultrasound
screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence
screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Lancet Oncol; 10: 32740, 2009
2. Menon U, Ryan A, Kalsi J, et al. Risk algorithm using serial biomarker measurements doubles the
number of screen-detected cancers compared with a single-threshold rule in the United Kingdom
Collaborative Trial ofOvarian Cancer Screening. J Clin Oncol 2015; 33: 2062–71.
3. Jacobs IJ, Menon U, Ryan A, et al. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet 2016; 387: 944 - 956
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