Has anybody had the new OvaSure test offered by Lab Corp.? My onc. ordered it for me yesterday. I was wondering how long it takes to get results, will insurance pay for it, that kind of thing. He was a little hesitant, had never even heard of it, but he took his time and read the little bit of info. I had for him. I reminded him that, even though I had a recurrence four years ago, my CA-125 never went above an eight, so the CA-125 is not an indicator that I can rely on. This test is so new that the tech. had to call Lab Corp. to see how it's done. Just F.Y.I., this is what I learned. They use a red top tube (empty, no chemicals), draw the blood and spin it. A serum will separate. They then carefully pour off that serum, freeze it, and send it to the lab. It is test number 004245. I am anxious to hear of other experiences with this new test. Thanks to anybody and everybody who takes the time to respond. Well wishes to all.
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New Ovasure test
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34 replies
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- By jeaniet
- Posted July 31, 2008 at 11:29 am
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Patty....no, I haven't, but please post the results, and how long it took, did insurance pay, etc. I am interested because like you, My CA125 was never above 21 so it's not an indicator for me either.
thanks and keep well.........Jeanie
- By verlinda
- Posted August 1, 2008 at 4:46 am
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I want to know, too. I was stage 2B, clear cell--yuck! My highest CA125 was 88, my lowest 16, so it responds, but seems to have a fairly narrow range.
Thanks.
- By socmom
- Posted August 4, 2008 at 11:03 pm
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Patty,
I am involved with another online website, ACOR and there is someone there who has used the LabCore test and it was not reliable for her. It showed that she was not having a recurrence and indeed she was. If you want me to get you info on this list serve let me know. There was very clear explanations of how they evaluate the results and there has been a lot of dialogue regarding this.
Cathy
- By PattyKey
- Posted August 5, 2008 at 5:10 am
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Hi Cathy,
I appreciate your reply. I would love to have whatever information that you are aware of on OvaSure. Please direct me to the website. Unfortunately, I'm not great on the internet. Technology left me behind around 1998! It would be interesting to know if the woman who was having a recurrence and showing negative with OvaSure, also had a CA-125 within the normal range, or if that was elevated. In other words, were both tests wrong, or OvaSure was wrong and CA-125 was right.
I don't know, it's like living with a concrete block hanging over your head sometimes, just waiting for it to drop on top of you. But I have nothing to complain about. I have been very, very blessed, very lucky, have a wonderful, caring, patient husband, have faith in my doctor, and count my blessings every day. At the same time, in the back of my mind, there is always that little tiny voice saying how long can my luck hold.
When I was first diagnosed I never once said why me, because the answer to that question is why not me. But I do question why I am so fortunate when there are woman out there who seem to struggle so, young women wanting to raise their children, young women who no longer have the ability to have children, and my heart goes out to them. Oh my goodness, life is a mystery. I just wish for peace of mind, wellness for each and every one of us, and the ability to live our lives with joy and happiness that we all so richly deserve. Thank you for your response. Patty
- By CaraPolicy
- Posted August 5, 2008 at 9:10 am
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OCNA's statement on OvaSure: http://www.ovariancancer.org/index.cfm?fuseaction=Feature.showFeature&Categ oryID=21&FeatureID=400
OCNA Encouraged by Release of OvaSure Test for Ovarian Cancer
On June 24, The Laboratory Corporation of America (LabCorp) announced that OvaSure, a test to detect ovarian cancer, would be available through its laboratories immediately. The Ovarian Cancer National Alliance is heartened by advances in early detection of ovarian cancer, and continues to urge women to remain vigilant about the signs and symptoms of ovarian cancer.
This year, more than 21,000 women will be diagnosed with ovarian cancer, and more than 15,000 women will die of the disease. Fewer than 20 percent of women are diagnosed in Stage I, when the chance of survival is greatest. A scientifically based early detection test, combined with awareness of the signs and symptoms of ovarian cancer, will help women get diagnosed early, and live longer, fuller lives.
OvaSure is a blood test performed in regulated laboratories. As a laboratory developed test, it is not FDA approved but does not require FDA approval for sale. “We look forward to the publication of Phase III trial data from the study later this year validating the test. This may, indeed, be a breakthrough in the detection of ovarian cancer,” said Dr. Karen Orloff Kaplan, Sc.D., Executive Director. She added that “we must wait for the data to come in before we rely on this test.”
According to LabCorp, the test is available as of June 24, and may be covered by insurance companies. OvaSure is meant to be offered for women with a high risk of developing ovarian cancer, including those at risk for a recurrence. The test will sell for approximately $225, and results will be available within four business days. Labcorp reports that the test is 99.4 percent accurate for positives (sensitivity) and 95.3 percent accurate for negatives (specificity).
- By ReneeK1
- Posted August 5, 2008 at 2:14 pm
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Wow, Patty said it all for me. Same here, pretty much every word.
I'm also interested in the info you can provide Cathy (as far as clear explanations of how they evaluate the results).
- By PattyKey
- Posted August 5, 2008 at 2:35 pm
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Hi again. I am going to my dr.'s office tomorrow and will ask for the results of the OvaSure test. Sure hope I can understand what it means. I am confused about sensitivity versus specificity. Those are the words in the last paragraph of the release that is printed above. Can anybody out there explain it?
Renee, thank you for your response as well. I sometimes struggle to put things into words. Good to know my feelings are shared by others. Thanks.
- By socmom
- Posted August 5, 2008 at 9:57 pm
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To all....
Regarding the woman I spoke about I believe her CA125 ending up being correct. But I want to give you the info about this list serve. To register go to: www.acor.org
Then you need to register on the ovarian cancer site. You will register and they will send you updates about twice a day. If you go on to post tell them you are interested in info about the Ovasure test and that you heard their were people with experience. THey will either fill you in or tell you how to get into their archives.
I hope this helps. This site is also full of alot of information. One of the three sites I seem to be attached to on a daily basis. It's kind of become an addiction; but I believe knowledge is power and control.
Cathy
- By CaraPolicy
- Posted August 6, 2008 at 9:27 am
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Sensitivity and specificity have to do with the accuracy of the test. Sensitivity means the positives are true positives, and specificity means the negatives are true negatives. High sensitivities mean there is a low rate of false positives, and high specificities means there is a low rate of false negatives for the test in question.
The wikipedia page explains it pretty well: http://en.wikipedia.org/wiki/Sensitivity_(tests).
- By PattyKey
- Posted August 6, 2008 at 12:24 pm
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Hi ladies. I'm back again with the results of the OvaSure Test. I have a calculated Risk Index of 0.00. According to the report, a risk index of .50 or greater indicates a positive reading and is suggestive of ovarian cancer. Huge sigh of relief!
However, my onc. had his nurse call the research facility with some questions, and she was told that the OvaSure test is not indicated for woman who don't have their ovaries!! In other words, for an accurate reading, you have to have ovaries. In the literature that I read it states that the test is meant for those at risk of ovarian cancer AND at risk of recurrence. Are there women who have had a diagnosis of ovarian cancer who still have their ovaries? I thought that was step one after diagnosis, have those puppies yanked out of there.
So if you had a hysterectomy after initial diagnosis, what good is this test as far as testing for recurrence?And isn't that such a big issue for all of us, the fear of recurrence?
Any comments will be most welcome. Thanks to everybody.
And CaraPolicy, thank you very much for clearing up the sensitivity/specificity question. That was helpful and I appreciate it.
- By gpawelski
- Posted August 7, 2008 at 10:55 am
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Dr. Gil Mor, associate professor, department of obstetrics, gynecology and reproductive sciences, Yale University School of Medicine and head researcher on the Ovasure project does not recommend the test for following recurrence after chemotherapy or surgery.
The test is available at Yale through the Discovery to Cure program. Yale has licensed the test to three companies: Lab Corp in the United States, Teva in Israel and SurExam in China.
Source: Karen N. Peart
Yale University
http://www.yale.edu/
- By sport
- Posted August 7, 2008 at 12:38 pm
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The reason OvaSure can't be used to check for recurrence of ovarian cancer is that after oophorectomy there are no ovaries.
- By PattyKey
- Posted August 7, 2008 at 1:22 pm
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That's why it's so disappointing. Because the literature says that it is acceptable for people at high risk of recurrence. It doesn't say anything about whether you have ovaries or not. And I can't believe that anybody that has had ovarian cancer would still have ovaries - so it makes no sense - checks for recurrence, but only if you have ovaries.
- By gpawelski
- Posted August 7, 2008 at 8:37 pm
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According to Dr. Gil Mor, all the clinical studies done so far for the serum-based diagnostic test (OvaSure) were focused on the detection of new cancers. The markers used are a combination of proteins produced by the tumor AND the ovary. In the case of recurrence the patient does not have ovaries therefore the markers can not work.
Yale researchers are working on developing a combination that can be used for recurrence, but that is in developmental stage. Mor strongly suggests not to use the test for recurrence until it has been evaluated in bigger studies.
- By a2dox
- Posted August 14, 2008 at 11:39 am
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I have an ovarian cyst that has started to get larger (7.2 cm now), and an aunt who recently finished treatment for ovarian cancer. The doctor thinks the cyst can still be removed through laparoscopy if we remove it soon so that it doesn't get any bigger. (The ovary measures 8.1 cm with the cyst which is just above his 8 cm limit for a laparoscopy.)
He offered me the OvaSure test (indicating that most insurance does not pay for it, though some might, and the cost is $222). Because the accuracy of the results is so much higher than the CA-125, and because I really need to have a good sense of how much work I might miss (one week for the laparoscopy, four weeks for full surgery), I opted to pay for the test so I could plan accordingly.
I was told that the results should be back in about 10 days to two weeks.
- By PattyKey
- Posted August 14, 2008 at 4:08 pm
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Hi a2dox. My test results were back within a week. The literature says four days I believe. Good luck with the results. Hope all signs are negative for ovca.
- By Gailiegirl
- Posted August 15, 2008 at 11:14 am
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I agree, there does not appear to be much benefit for those of us who have already been diagnosed, had surgery, and chemo, but lets look to the future of our daughters and granddaughters, I have tested negative for the genetic markers, but truly believe that testing for all undiagnosed women that is accurate is an important part of battling OVC in the future and wish that my family already had this option. I will certainly talk about OvaSure to my friends and family and hopefully, with final test approval, it will become standard of care for every womens' annual OB/GYN checkups
- By a2dox
- Posted August 21, 2008 at 3:48 pm
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I did get my results back today (within a week). I have a calculated risk index of 0.0 (and I do still have my ovaries at this point), so I'm hoping that the test is as accurate as they claim.
And I sincerely hope they come up with something for those who may have a recurrence (and have already had their ovaries removed).
- By Gwen1
- Posted August 22, 2008 at 11:23 am
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For anyone considering the OVASure test, you may be interested in the article "FDA Questions LabCorp in Its Ovarian Cancer Test Service" at: http://www.oncologystat.com/home/news/FDA_Questions_LabCorp_on_its_Ovarian_ Cancer_Test_Service.html
A partial excerpt from that article is given below...
"Based on our review of your promotional materials and the research publication cited above, we believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health," writes Gutman to LabCorp CEO David P. King. "We would like to discuss with you your offer of this test, and any validation strategies you have undertaken...."
LabCorp says the test discriminates between disease-free women and stage I-IV ovarian cancer patients with a specificity of 99.4% and a sensitivity of 95.3%. But FDA suggests in the letter that those numbers are based solely on a study published by Yale researchers in February that compared results from women recently diagnosed with ovarian cancer to a control group of healthy women.
The data results from "two populations that are strongly clinically biased for being healthy and normal, and for having already experienced ovarian cancer," Gutman writes. "Based on the available information, we do not believe the scientific community would consider the reported study sufficient to establish performance characteristics of a test in 'high-risk women who might have ovarian cancer,' i.e., in a clinical setting, as claimed in your intended use and promotional materials."
- By laurainnj
- Posted August 28, 2008 at 11:27 pm
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I took the Ovasure blood test four days ago and have not received the results yet. My OB/GYN recommended that I take the test because I may fall into the high risk group of women with the BRCA2 gene. I'm having genetic counseling next week and I hear it takes about a month to get the results back.
Once I get results from the gene and Ovasure, I hope I'll have enough information to decide whether or not to have my ovaries removed.
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