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 kathy6
- Posted November 24, 2008 at 11:46 am
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OvaSure Ovarian Test
An FDA warning has prompted LabCorp to stop sales of a controversial blood test for ovarian cancer. Experts have raised questions about whether OvaSure is effective. OvaSure had been offered without FDA approval because diagnostic checks are sometimes exempt from federal regulation if they are developed in a single laboratory. However, OvaSure was developed in conjunction with Yale University.
LabCorp Stops Selling OvaSure Ovarian Cancer Test after FDA Letter
October 31, 2008
Facing pressure by the Food and Drug Administration over its OvaSure test for ovarian cancer, Laboratory Corporation of America announced last Friday in a Securities and Exchange Commission filing that it had stopped sales of the test. The dispute between the FDA and the nation's second largest laboratory company will be closely watched for insights into how the FDA regulates "home brew" assays.
- By PattyKey
- Posted November 21, 2008 at 5:11 pm
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Hi Lani,
Thank you so much for your kind words. I know one thing for sure, when you have a cancer diagnosis, no matter how long you live, it is the end of peace of mind. We spend so much time worrying about trivial things, things that we really can't change, but all that really matters is people and health.
You take care, and thank you. Patty
- By Laniphil54
- Posted November 21, 2008 at 4:03 pm
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Dear Patty,
I am just newly diagnosed and finishing my 7th week from surgery. I have not used the Ovasure but was very touched by your reply to Cathy. I have experiencing the same thoughts and feelings the past two months and could not have put it more beautifully. Sometimes I feel guilty when reading about others that are going through such horrible bouts with the chemo. I have vowed that I will educate every woman I touch with the symptoms to look for with Ovarian Cancer. It is now my job to do this. It is my way of thanking God for keeping me here. Take care all,
Lani
- By joseph2
- Posted November 21, 2008 at 1:25 pm
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For what it's worth, here's a link to a NYTimes article on OvaSure from August.
Ovarian Cancer test for women raises hope, and concern
I have been following the progress of OvaSure as a diagnostic tool since January. Some nurses I have spoken to are of the opinion OvaSure is not perfect but as it is more accurate than a CA 125 as a detection tool, it should be used in conjunction with all the other diagnostic tools. While it hasn't passed all three phases of FDA scrutiny, it has demonstrated enough reliability in the first two phases. The problem it had with the FDA was a marketing hurdle.
The reason why I say "some nurses" rather than "some doctors" is that nurses don't have a vested financial interest in either promoting OvaSure or creating more hurdles for it. Doctors who issue opinions to media regarding the OvaSure dispute may be part of teams trying to develop their own product, whether its OvaSure or another. To be honest, at this point, I trust the nurses more than I trust the doctors when it comes to a new product.
If you want to read something chilling on the way doctors with products in development work over the media, read this article form the Columbia Journalism Review of a few days ago:
Science reporting by press release: an old problem grows worse in the digital age
Also, I write about these issues sometimes myself. If you have an opinion or experience with OvaSure and the way it's being rolled out, please feel free to contact me:
joseph.mailander@gmail.com
I'd love to hear from you!
- By lupirob
- Posted November 21, 2008 at 10:43 am
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I'm pretty sure this is the test developed at Yale. The FDA has put some sort of a hold on it. My understanding is that it is useless once you have had OVC and had your ovaries removed. It was designed as a screening test. Your onc should have spent more time looking into it.
- By CaraPolicy
- Posted November 21, 2008 at 7:22 am
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Yes, the test was pulled from the market. I have posted a number of times about this, but please note that the data isn't in on this test. There are issues around this data and around who gets to approve the test. That's what's going on now - if it's an FDA test, then more data is necessary to prove that the test does what it says; that data isn't yet in, and it hasn't been submitted to the FDA, at least to my knowledge.
For right now, know that the test was not approved by the FDA, and that Phase III data has not been released.
I'd love to talk to anyone who has taken the test - please feel free to e-mail me at the OCNA office (advocacy@ovariancancer.org).
- By gpawelski
- Posted November 21, 2008 at 12:48 am
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Thanks PattyKey, an email just showed up for this particualr thread in Ovarian Cancer Alliance in regards to Ovasure. I had previously posted it on CaraPolicy's Journal thread.
Dr. Gil Mor, associate professor, department of obstetrics, gynecology and reproductive sciences, Yale University School of Medicine and head researcher on the Ovasure project originally did not recommend the test for following recurrence after chemotherapy or surgery.
According to Dr. Gil Mor, all the clinical studies done so far for the serum-based diagnostic test 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.
This test is an earlier version that researchers at Yale School of Medicine have developed to detect early stage ovarian cancer showing 95 percent effectiveness of a blood test using four proteins. Yale researchers have validated the previous research.
The same Yale group is working on validation trials of another blood test with enough sensitivity and specificity to detect early stage ovarian cancer with 99 percent accuracy. Results of this new study were published in the February 15 issue of the journal Clinical Cancer Research.
The new platform uses six protein biomarkers instead of four. Previous tests recognized 15 to 20 percent of new tumors. Proteins from the tumors were the only biomarkers used to test for ovarian cancer. Testing the proteins produced by the body in response to the presence of the tumor as well as the proteins the tumors produce, have helped the Yale group create a unique picture that can detect early ovarian cancer.
One could try to contact Karen N. Peart at Yale University for more information from their researchers: http://www.yale.edu/
Lovelexi, even the CA125 tumor marker (blood test done to assess the amount of an antibody that recognizes an antigen in ovarian tumor cells), the rate of false-positives makes it inadequate for use "by itself" for screening of high-risk patients. It should be supplemented with transvaginal ultrasonography and a rectovaginal pelvic exam all done at the same time. It looks like you've had them.
Even a laparotomy, a surgical procedure which involves opening the abdominal cavity for examination, which is supposed to be the most certain way of diagnosing ovarian cancer and assessing the extent of cancer spread, negative second-look patients have a 50% chance of disease recurrence anyway.
- By PattyKey
- Posted November 20, 2008 at 11:35 pm
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Hi Lexi, Hang in there and try not to worry too much. I have posted a note to a man who frequently posts on this site under gpawelski. I think his name is Joseph, but I might be wrong. Anyway, he is so very knowledgeable and is very, very generous with information. I have asked him to address your concerns because I just don't know what to tell you. I jumped on the OvaSure test as soon as I heard about it, got excellent results, but then found out that it is only indicated for women who still have ovaries. I don't qualify. So it seems that it may be one of those unfortunate things that was sent to market too early, and I am sorry for you about that. I also had high hopes.
It sounds as if your family has greatly suffered through this disease called cancer, and you are understandably concerned. But the best advice I can give you is to find an excellent doctor, and maybe even a second opinion doctor, one that you are comfortable with, and put yourself in his/her hands. I understand what you are saying about knowing your own body, but with what you have been through, it doesn't seem that it would be too far fetched that your mind might play tricks on you. This is what I tell people who tell me I put too much faith in my doctor -- I have no other choice but to believe in a person that I trust, who is smarter than I am in this particular field, has a good reputation, and if I can't trust him, I will never have peace of mind. And so with that in mind, I do ask questions, I am aware that he has God-knows how many cancer patients, but I only have one - me. And so I learn as much as I can, ask him what I don't understand, and have hope and faith, and then try to get through with as much grace as possible.
I feel so badly for you, that you have this hanging over your head, we all do. But I believe with cancer early detection is everything - everything. And if you stay diligent, keep up with regular testing, if you are so unfortunate to have to go through actually having cancer yourself, hopefully the early detection will make your outcome better than that of your many dear family members who have suffered so much.
I hope gpawelski will be in touch soon. And in the meantime, if you just want to talk, please use my e-mail address pwkey@bellsouth.net.
And please forgive me if I sound too preachy. I don't mean to. I feel so sorry for the fear that you live with, and wish I knew how to take that away. I am sending prayers and good vibes your way for a long, long, long, and very healthy life. Patty
- By PattyKey
- Posted November 20, 2008 at 11:06 pm
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Hi - I believe your name is Joseph? True? If not, I am sorry. I don't know where I got that idea. Anyway, if you would be so kind, would you address the issue raised by Lovelexi in the blog that I started on the Ovasure Test. You are so knowledgeable and could probably help her so much more than I. I know I jumped on the Ovasure test as soon as I heard about it, and then learned it had been taken off the market. Lovelexi seems in desperate need of some peace of mind, and maybe you can help her. I thank you, thank you, thank you so much.
- By lovelexi
- Posted November 20, 2008 at 8:05 pm
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HI PATTY, I CANT BELIEVE THIS. I WAS GIVEN A
SCRIPT FOR THE OVASURE TEST YESTERDAY AND
WAS LOOKING FOR INFO ON LINE. I CAME ACROSS
YOUR CHAT ON INSPIRE.COM AND READ THROUGH
ALL THE RESPONSES WITH SUCH HOPE. FINALLY,
I THOUGHT I MAY GET SOME INSIGHT TO MY SYMPTOMS AND GET SOME ANSWERS TO WHAT I
AM ALWAYS WORRIED ABOUT....OVARIAN CANCER!
I HAVE DONE ALL GENE TESTS, NEGATIVE, EVERY
6 MONTHS TRANSVAGINALS AND SONOGRAMS AND
RECENTLY A PELVIC CATSCAN. ALL NOTHING, YET
I KNOW MY BODY AND ALL MY SYMPTOMS POINT
TO THIS HORRIBLE DISEASE THAT KILLED MY MOM, HER MOM, MY AUNT, AND MY UNCLE WHO HAD COLON CANCER. WITH ALL THE INFO I JUST
READ ON THIS TEST I JUST CAME ACROSS AN ARTICLE POSTED ON OCT. 29TH THAT LABCORP
IS NO LONGER DOING THE TEST. I AM NOW DEVASTED AND WANTED TO KNOW IF YOU OR ANYONE ELSE KNOWS WHERE ELSE I MAYBE ABLE
TO GET THIS TEST DONE. PLEASE ANSWER ASAP AS I DONT THINK I WILL BE ABLE TO SLEEP TONIGHT. THANKS
- By Anderson_JB
- Posted November 5, 2008 at 5:04 pm
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According to the FDA, LabCorp is in violation of the law by offering this test as it has not yet gone through the necessary approval processes.
See the FDA's letter to LabCorp at http://www.fda.gov/foi/warning_letters/s6947c.htm.
- By sport
- Posted September 21, 2008 at 10:52 am
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Again, OvaSure is only for women with ovaries.
- By laurainnj
- Posted September 20, 2008 at 10:22 am
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I received a negative result from my Ovasure test and, surprise, Aetna paid for the lab test. I now am waiting for results from genetic testing for the BRCA2 gene.
- By Bboo
- Posted September 8, 2008 at 9:17 am
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Hi,
Just wanted to let you know you can get the Ovasure test online. You need to pay for it yourself and it can be a bit expensive, but you don't need a doctor's order. It only seems to be for early detection & not a recurrence.
http://www.personalabs.com
Bboo
- 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.
- 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 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 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 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 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.
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