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A Possible Answer for Unexplained Infertility? An Interview about ReceptivaDx | Chris Jackson

Chris Jackson, CEO and Founder of CiceroDx, maker of the ReceptivaDx test, has been in diagnostic lab testing for over 30 years focusing on health care sales and marketing. Mr. Jackson has launched over 35 products during his career, with the majority in the field of women’s health & reproductive medicine.


Women told they have unexplained infertility struggle to find solutions. ReceptivaDx tests for a biomarker - BCL6 - and may provide answers for these women and couples. This episode speaks to the test and what women can do should the test positive.

Transcript


Chris Jackson  02:15

Right now what we're doing is helping women understand the potential of what unexplained infertility means.  That shouldn't be a diagnosis. It's just a label given to someone where people are giving up and they don't know what to tell them, they run out of answers. And so what ReceptivaDx does is provide answers that are different from everything else that they're getting. And it's pointing towards the uterine lining and the information it might be able to provide as to why these people aren't getting pregnant. What we're picking up is very mild or asymptomatic endometriosis, which no one was thinking about, that could be impacting their ability to get pregnant, or stay pregnant. So the test is done when they would normally be trying to conceive, they would send it to our laboratory, they get results back in about four or five days. And then that information can be used by the doctor if it's positive to treat this person and give them a new pathway to pregnancy that they never thought would happen for them.

Georgie Kovacs  03:16
What resonates with me is unexplained infertility, and obviously more so because I have a personal story around it. I ended up going through 10 of the best doctors in the country constantly being told I had unexplained infertility. And I don't know if it's because I'm a dreamer or because I come from the healthcare field. I was very convinced that it just meant they either didn't know yet because science didn't catch up, or they weren't trying hard enough. And lo and behold, I had some immune blood work done. And the hypothesis was that I had endometriosis but happened to be asymptomatic. My surgeon went in with the laparoscopy and I had it and more than they had thought and I got pregnant the first IVF after.  

Now, I'm not at all saying everyone go get surgery and you're automatically going to get pregnant. It wasn't that simple. But you know, I definitely hear what you're saying. And it's great that you guys are trying to solve this. 

So let's back up to your background and your role with this and how you've got to today and then we can dive more into ReceptivaDx.

Chris Jackson  04:25

I've been in women's healthcare startups almost my entire career.  I've been involved with genetic testing for things like cystic fibrosis. I was with the company at the launch. The first commercial test was involved in the test for preterm labor to assess women that are showing up in hospitals thinking they might be in preterm labor. So that's a quick assessment that has never been done before. 


I have always gravitated towards women's health care and I've actually been a good friend and involved in a couple different business ventures with Dr. Bruce Lessey, who is the person behind all the research that the ReceptivaDx test is based on. He and I stayed in touch, and he let me know that he found something that was very, very exciting and spent some time with him and looked at it. And I said, “This is tremendous, but can we help the women?  Everyone can find markers, and we don't know what they mean.”   


He found this marker, it shouldn't be there when a woman is trying to get pregnant. But for some reason, all these women that couldn't get pregnant, that marker was there. So we thought we had something but now it's like, what do you do for them? So then the next step was to get involved with that. It’s been a blessing.  We're helping a lot of people. 


I never thought it'd be in this position, but we now have over 300 fertility centers. I just talked to somebody in Dubai, and we have a center there now that's doing the test. We've got people in Saudi Arabia, they're gonna be doing the test that just blows my mind that we start something and then we're helping women all over the world.

Georgie Kovacs  05:59
Right? The test looks at BCL6. And what exactly is BCL6?

Chris Jackson  06:08

BCL6 is that protein I was just talking about that we found. It's a marker of inflammation that's actually been used in lymphoma profiles to help people understand progression of their lymphatic disease. It just happened to be a part of these proteins that we looked at in the sequence - two that were showing up in abnormal uterine lining. When I say abnormal, meaning these folks couldn't conceive, versus women that had normal uterine lining that didn't have this, so we started working backwards.  


What's happening there? 


Not only is it a marker of inflammation, and you just think of any type of situation, where there's something going on that shouldn't be BCL6 is an inflammatory reaction to endometriosis somewhere else in the body. So it's not on the uterine lining, necessarily. It could be in the pelvic area, it could be on the ovaries, but the immune response for endometriosis is inflammation on the uterine lining. 


That inflammation we found is enough to create havoc when a woman's trying to get pregnant. When it's not there, the women's chances are much better and IVF of people that have it, their chances for success if they don't do anything or less than 12% in IVF attempts, so very powerful information when that came out. And then we started looking at the treatment options to see if we could help.

Georgie Kovacs  07:41
Incredible given that there's just so little research right now and women's health. Even when you look at the numbers for endometriosis (at least 1 in 10 women have it), this is such an incredible finding. 

Would you say that if you test positive for BCL6, you likely have it, and if you test negative, there shouldn't be a concern? Can you explain that nuance, please?

Chris Jackson  08:22

The only way to diagnose endometriosis is to go in with a laparoscopy and visually see it. So we use the word detect. When we say detect, this is an indirect measurement of that. So it's very similar to other things where you might be measuring something indirectly, but it's directly related to that condition, so a lot of tests are actually like that. 


What we did in this study, when we looked at the BCL6 markers, we had 123 women in the original study, and they all had unexplained infertility, and that meant, over 35 try naturally, for at least a year, under 35, at least six months. They hadn't had any procedures like IVF. They had ruled out other male factors and female factors first, but all those women agreed to be biopsied. When the biopsies came back in those women, 65 of those 123 women tested positive for the BCL6. 


Everyone in that study agreed to be scoped and so we're very pleased that, out of the women tested negative, the chances of seeing anything were less than 3%. So we felt really good that we weren't giving out any false negatives in that regard. On the other side of it, out of the 65 women that tested positive, 62 of them actually had visible endometriosis. So that's when we felt very comfortable. Now you're talking about sensitivity and specificity levels, about 90% and that's rare in a lot of things in medicine.  


For the other three women in the study:

  • One, we could not see anything

  • The other had a blocked fallopian tube

  • The third one had adenomyosis, which is growth on the outer uterine wall that was there. 


So other things can cause inflammation and trigger the BCL6 to be positive, but the majority of the time, you're probably looking at the endometriosis. 


And if you don't mind, I just want to say something about endometriosis - this is not your mom's endometriosis. They're not doubling over and pain. They don't have painful intercourse.  They don't have painful periods where they're just cramping severely. This is the first time they've even thought about it, and that's where that data came in. 


Trust me.  Introducing a test and telling a doctor, “These patients might have endometriosis” is hard.  It's been out of sight, out of mind.  No one's talked about it.  No one's looking for it. And a lot of the reproductive endocrinologists (REIs) today don't offer up laparoscopy like they did 20 or 25 years ago.  That was a standard procedure in fertility workups. They would find endometriosis all the time, but what happened is it just kind of got pushed to the side because laparoscopy was expensive. Insurance didn't want to cover it unless you had gla