Results reported in this JCO article,
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 of Ovarian Cancer Screening
found that using the risk algorithm detected double the amount of invasive epithelial ovarian cancers, before the CA-125 alone, at a fixed, 35u/ml cutoff. .
Earlier this month I was contacted by a representative of the PR firm that is representing Abcodia, a company that develops early detection tests for cancer. On December 2, 2015 Abcodia launched the ROCA (Risk of Ovarian Cancer Algorithm) test here in the US. After finding and reading my blog, the firm contacted me to share that the test was now available. Of course I was interested in learning more about this test that was now available in 5 states - Texas, Massachusetts, Illinois, Arizona and my home state of New Jersey. You can find the press release at http://www.abcodia.com/news_
We conversed via e-mail and then I had a teleconference with the PR firm's representative as well as the representatives from Abcodia. Abcodia's responses to my questions are shown below in quotes and italics. I have permission from Abcodia to share the information provided.
- What is the difference between the ROCA test and the CA-125, which is one component of the ROCA test? "The ROCA Test does not use CA-125 with a fixed cutoff, instead, ROCA establishes a patient’s baseline, and then evaluates her CA-125 pattern over time." (CA-125 uses a fixed cut-off of either 35 u/ml or 20 u/ml depending on which test protocol is followed. "ROCA incorporates the CA-125 result (and all the following CA-125), and, factors in age,
menopausal status and high risk factors, which affect CA-125 levels. ROCA takes all of this data on one patient and creates a unique profile for her. ROCA then compares her profile to known profiles in a database of thousands of women to see if her profile more closely resembles that of women who have cancer or women who do not have cancer. The ROCA Test reports a
numerical score which represents a woman’s risk of having ovarian cancer (e.g. 1 in 5,000) now. The risk score is categorized as Normal, Intermediate or Elevated as a guide for clinical decisions by your doctor."
- Who is the ROCA test meant for and when should they have it? The ROCA test is meant for women in the general population who are "Between 50 and 85 years and have been through menopause; or" high risk women "Between 35 and 85 years with a family history of ovarian and/or breast cancer, are of Ashkenazi Jewish descent with a known family history of ovarian or breast cancer, or have tested positively for BRCA1, BRCA2 or Lynch syndrome gene mutations." The CA-125 may be used for high risk women only. The test would be similar to "Routine testing, just like you would a physical or mammogram." Currently the CA-125 with a fixed cutoff is sometimes used for high risk women only when advised by their physicians. As many of my readers know, the CA-125 is used by gynecologic oncologists to manage the care of women who have been diagnosed with ovarian cancer.
- How does the ROCA test compare to the CA-125 in terms of how well it detects ovarian cancer?"When combined with appropriate clinical follow-up, the ROCA Test has been shown to detect more than twice as many ovarian cancers before the current CA-125 35U/ml fixed cutoff. As a screening tool by itself, CA-125 is not reliable and has not been shown to improve outcomes for women with ovarian cancer."
- How does a woman go about getting the test? She fills out a form online to see if she is eligible and orders the kit. Then she finds a referring physician (OB-GYN or primary care physician) to sign the request for the test and the blood work. "Abcodia is proactively educating OBGYNs, has a dedicated phone line and online materials specifically for healthcare professionals."
- What is the cost of the test and is it covered by Medicare, other insurances? "The cost of each ROCA Test is $295. This includes the cost for the Iggbo blood draw service, who will have a trained phlebotomist come to a doctor’s office, a patient’s home or other location of the patient’s choice to draw blood. Iggbo will then ship the blood sample via FedEx to Abcodia’s laboratory." Abcodia's lab is a CLIA, registered lab. Currently the test is not covered by Medicare or other insurances. "Abcodia does plan to seek regulatory and reimbursement approvals"
- Can a woman get the CA-125 drawn at a different lab and then submit it to Abcodia? It is recommeded that the blood draw be through Abcodia's blood draw partner, Iggbo. A patient can have her blood drawn at her physician's office or a hospital if a phlebotomist is available. All samples do need to be tested at the Abcodia lab to insure there is no lab to lab variability. CA-125 test results from other labs (Quest, Labcorp) for use with the test are not accepted.
- What happens after the initial result? "The frequency of the ROCA test will be determined by the woman's doctor based on her risk factors for ovarian cancer and the ROCA test result. Post menopausal women with no additional risk factors will likely have one test per year. Women at high risk for ovarian cancer , will complete the test more frequently, at a minimum three times per year and may include a Transvaginal Ultrasound (TVU). If the result falls outside of the normal range(intermediate or elevated) a doctor may recommend a repeat ROCA test within the next six weeks to three months. Patients may also be referred for a transvaginal ultrasound scan of the ovaries or other possible clinical assessments. "
- Does the women pay $295 each time she has a follow-up test?"After a patient takes her first test, Abcodia offers the patient several options: 1. The patient can pay per test ($295) for each test. 2. The ROCA Test Subscription: one for high risk patients and one for the general population. Abcodia will offer patients a 2 year subscription that includes the Iggbo blood draw, repeat ROCA tests and TVU (Transvagina Ultrasound) as a result of intermediate, elevated or severe ROCA result. 3. Interest free payment plans."
- Why is the test available in only five states ? Starting in five states will allow the test process to be optimized. The delay with other states is due to each individual state's permit application period and process. Some are longer than others.
This video is an overview of how the ROCA test works.
I have charted my CA-125 results since my initial diagnosis. So monitoring the trends in CA-125 makes sense to me. But there is one caveat, there is a small percentage of women, like myself, who have a CA-125 result that is normal and disease may be still present. My CA-125 was normal at 17 u/ml, when I learned via CT scan that I had recurred on my liver and spleen. So woman whose CA-125 does not rise may not benefit from this type of screening.
I still had a few questions about applying this test to the general public. I wondered if the ROCA test would find the disease at an earlier stage and if the survival would be longer for women whose disease was detected by this test. I did not have to wait too long for some of the answers because on December 17th the results were published in the Lancet journal.