Focus On Fertility Talks ReceptivaDx

ReceptivaDx is the latest subject discussed on the “Focus on Fertility” podcast! Dale Bader, the host of the podcast, interviews our president and CEO Chris Jackson. During the podcast, they discuss how ReceptivaDx is helping women with unexplained infertility or a history of failed IVF identify a new pathway and treatment plan in their goal to start a family.

Focus on Fertility is a weekly podcast aimed to assist those who may be experiencing difficulties conceiving by providing answers and education through meeting with experts in the world of reproductive medicine.

Click here to hear the interview. The podcast is also available on all of your favorite streaming services including iTunes, Google Play Music, PodcastOne, iHeart Radio, and TuneIn
Episode 5 – ReceptivaDx: A new test to help bring success with unexplained infertility and/or prior implantation failure. (April 17, 2018)
“Christopher Jackson from CiceroDx discusses the new ReceptivaDx test. This test is beginning to be utilized to assist patients who have experienced prior IVF/embryo implantation failure. We’ll learn about ReceptivaDx, hot it works, and how it can assist in improving success rates with IVF.”

Here’s a transcript of the entire discussion:

Dale: Good day it’s Dale Bader and we are ready to do yet another edition of Focus on Fertility. Today we are blessed to have a guest joining us all the way from California: Christopher Jackson. He is President and CEO of CiceroDx, and he is going to be presenting information today on a relatively new test for those of you who might be dealing with prior failures with your IBF transfers, or just simply have had failures with unknown reasons why. Chris, we’d love to learn more about the ReceptivaDX test.

Chris: Thank you for the opportunity. Just as a background; unexplained infertility is a major issue in the United States, and for women that are seeking fertility help, there’s a large percentage that have the diagnosis of unexplained infertility, meaning there are no clear reasons that can be easily identified in either partner . At that time, they’ll come and visit a fertility center and they’ll look at various options. Our test is available not only as an up-front test for patients but is used right now for patients that have failed IVF, have had multiple pregnancy losses after an IVF transfer where they thought the embryo stuck and then, unfortunately, lost the pregnancy. What our test is doing is identifying the cause.

Even the best fertility centers in the country have about a 65% success rate. We’re focused on that other portion, that 35%, in getting to the bottom of what’s going on. The most common explanation for that, believe it or not, is endometriosis. With endometriosis, people are usually thinking about someone who has heavy menstrual bleeding, painful intercourse, abdominal pain, that type of thing. They don’t think of their fertility as being an issue, and so endometriosis even in a very mild form on the uterine lining can cause issues with someone’s ability to get pregnant. What we’re doing for the first time is providing a test that can identify endometriosis without having to do any type of invasive surgery.

Dale: So, it’s very common for individuals who are going through, maybe they’re having difficulties becoming pregnant. They’ll go through with their OBGYN, and if they have stage 2, stage 3, stage 4 endometriosis, those are pretty easy to diagnose and see. This is actually going to help diagnosis maybe those that are not being truly diagnosed in the office early on. Is that kind of what we’re going with this?

Chris: Exactly. The patients that we’re talking about are patients that endometriosis was the furthers thing from their mind. They did not have any of the classic hallmark symptoms that you’d think of. Even for the doctors in the reproductive community, you’re not thinking that. You’re thinking, “Okay, it’s a male factor. We fixed that”, or “It’s this and we fixed that”, or “We’ve got genetically tested embryos.” But yet there’s a certain sub-group that continue to fail. What our test can help do is identify those patients where endo is the cause of their frustration. You’re talking about patients that have tried everything at that point, and now all of a sudden, we’re coming along and detecting a problem that no one thought of and it’s not only offering hope, it’s offering a new pathway to success for these patients.

Dale: How does this test work? What type of process is involved for the patient and for the clinic?

Chris: Well, the test right now is an endometrial biopsy and it’s done during the window of implantation. A patient would be watching when they’re ovulating and would have the biopsy taken about 7-10 days after ovulation has occurred. The sample is then set off to our laboratory. It takes only about three or four days to get results back, and a good majority of the patients, 75% of the patients in the unexplained infertility category will test positive. As staggering as that sounds, it provides a big opportunity for a lot of people that didn’t think they had any opportunities left. Once they’ve found the endometriosis, the patient has two pathways. One is to consider surgery, laparoscopy, where they would go in and look and remove anything that was there. The alternative to that, and there’s going to be some studies coming out soon where they can use hormone suppression therapy for about 60 or 90 days to give them a course of that. It suppresses the endometriosis long enough for the embryo not only to attach but to stay attached throughout the entire pregnancy. We’re getting really good success rates with this therapy. We’ve got some great success stories coming up, folks that come to our website (www.ReceptivaDx.com) can actually see some videos of some patients that had almost given up hope, had the test done, had a pathway identified and ended up with a pregnancy and a successful live birth.

Dale: What kind of success rates are we seeing with those patients who have chosen to utilize this test, has gone through some treatment and moved forward that point?

Chris: That’s a great question. First of all, if someone tested positive for our test, if they were left untreated, subsequent transfer temps are successful less than 12% of the time. It’s that continuing to do the same thing and expecting a different result. Meanwhile there’s an emotional toll, there’s a physical toll, a financial toll and a toll on the marriage. The treatment paper that will be coming out, shows that these patients once they have the test result and the intervention with the hormone therapy, are back up to a 63% success rate on their next transfer after that treatment. Very great results coming out, very positive news for a lot of patients, and we’re talking about patients that just about gave up that idea of having a family.

Dale: How long has this test now been available, and is it becoming more widely available at clinics across the country?

Chris: We now have over 175 IVF centers across the country doing the test. The test has only been out since January, 2017, and we worked as hard as we could to get it out to the community as soon as possible. It’s just now in the past six months really taken off because the centers are finding out about the test and its availability. It takes a while for doctors. They’ve got so much on their plate to be able to catch up with all the clinical data, and sometimes patients know about the test before a doctor does so that’s always an interesting situation. We have some great downloads for the patients they can bring in to their doctors, discuss that with them. We have doctors that their physicians can speak with as well to consult not only about the testing but about the treatment options and those individual patients.

Dale: I know this is always a tough question but when we’re dealing with infertility patients, one of the questions always number one is: what’s my success chance going to be? Number two is: what’s the cost going to be to me? Is this something that insurance is covering at this time, or is that still in the works, and is it a cash option for patients?

Chris: Well, insurance right now is taking a look at it and a lot of it comes down to the coding for the submission to the insurance. To make that a little bit simpler, if you don’t have fertility coverage chances are it won’t get paid, so it remains an out-of-pocket test. It’s $690, and while I understand that’s a lot of money, it’s kind of a great thing to look at before you go and spend money on…

Dale: Another transfer, two transfers, three transfers…

Chris: Right. It’s all relative in that side of it, but for most patients at that point it’s, “Give me hope, give me a sense of direction that there is still an opportunity for a family”, and that’s the greatest thing about this test in the last 15 months. What’s exciting for us is that there are babies being born last month and this month that account for the first group of babies that were born as a result of their moms getting tested, treated and then having a successful transfer.

Dale: You had mentioned endometrial biopsy and you and I were talking off air a little while ago. Some people may be thinking, “Oh, well I’ve heard of another test that does something like this”, but as we were talking off air, this is kind of another tool to work together. They’re not replacing each other, they’re complimenting each other.

Chris: That’s correct. There’s all kinds of tests out there, and your doctors will walk you through each of those and what they’re clinical utility is. As a patient, you are a consumer too so it’s good for you to make sure you understand what all these tests do. The easiest way to describe out test is that there are tests out there that will look at the embryos to make sure they’re genetically perfect. I hate to use that word, but that’s how you’re genetically tested and graded. There’s a test out there that also decides when the best window of implantation is. What we describe to people is that you’ve got this perfect house guest, you’ve got this perfect timing of when that house guest should show up for the next nine months. Did you bother to check to see if the house is cleaned up and inviting for your guest to want to stay for the next 9 months? If it’s all cluttered they’re not going to stay, and it’s the same thing for that embryo. We’re checking the uterine lining making sure there’s nothing there that’s going to cause any dysfunction that would prevent an egg from attaching and staying attached.

Dale: Are there any upcoming next steps that we should be looking forward towards?

Chris: Well, there’s a lot of research going on. A lot of it would be premature to talk about. Our long-term goal is to be able to see if we can identify markers such as the BCL-6 marker in our current profile in other sample types. We in the industry consider endometrial biopsy being non-invasive, which means it’s not surgery. Yet at the same time, it is painful and we understand there’s discomfort. Our goal, is to look at the technologies where maybe a pap smear, or a saliva test, or a blood test where we can identify these conditions at least in advance. It’ll maybe help a patient, a young girl at 21 who for no reason should be having heavy menstrual periods, but maybe has endometriosis which could end up being long-term scarring that might prevent here from being able to have a baby later in life. If we can identify patients like that, that’s a lot better information. Twenty years ago, they were told they had irritable-bowel syndrome or, “that’s just your period, deal with it”, and they weren’t offered a lot of hope. That’s our long-term goal, to be able to identify endometriosis sooner. Right now, I think the statistic is that it takes 11 years for the average person to be diagnosed with endometriosis in our country, and you’re talking about the United States. You can imagine what it’s like in other countries.

Dale: Well, thank you so much Chris. This has been very interesting and mind-exploding in some ways because it’s brand-new, it’s kind of hitting the field now and we’re going to look forward to seeing the latest developments coming down the line. We’re big on talking about screening and to know that this could be other at another screening will not only help now for people going through infertility but as you were saying earlier, diagnosis of endometriosis and how that can help somebody with their family planning years in advanced. It’s pretty exciting to think of as well so, thank you so much.

Chris: Thank you. I appreciate the opportunity.

Dale: If you would like to get additional information regarding the Receptiva test, you can visit them on the web at www.receptivadx.com. They have some great videos that you can watch as well as get some additional information, or you can always ask your reproductive specialist.

Bruce Lessey, M.D., Ph.D. – Scientific Advisor
Lessey’s Corner

The ReceptivaDxTM Test was developed by CiceroDx in conjunction with Pathology Consultants, Inc. of Greenville, SC. Pathology Consultants, Inc. is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies. Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.


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