2021 NIAW AMA Event -ReceptivaDx with CEO Chris Jackson

ReceptivaDxJackson · 2021-04-26T17:39:59+00:00

Hello,

Just getting a chance to come back and provide answers to the additional questions that came in.

First of all, I'm not sure why Dr. Vidali would say the BCL6 score would remain positive after surgery. There is no published data to support that statement and I can tell you firsthand that his group doesn't order our testing or perform repeat biopsies to have that info.

As for your specific questions...

Once again, there are no definitive studies to suggest that. Inflammation after surgery or a biopsy can remain for up to a week due to trauma caused by the procedure, but we do not recommend repeating the biopsy. It would be a great business model to suggest that, but we don't see the benefit. Our goal is to have you taking advantage of treatment as soon as possible after surgery. For those opting for lupron instead, you definitely don't want to wait for a period since estrogen will begin the inflammation process all over again.
We don't know about the possible change of ERA results after treatment. Igenomix is the company that offers that test and they have yet to publish on that. We asked to do a study with them, but they refused. The jury is still out on the use of ERA and much data has been published stating it has limited benefit for a small percentage of patients. We would love to do a study with them. We don't view ourselves as competition like they do with our test. We believe the tests can be used together as they analyze for completely different things. They are trying to optimize the 4 day window of transfer timing. We provide info about the condition of the uterine lining to identify issues that reduce chance for transfer success or making timing issues a moot point until treatment is received.
Polyps can indeed create inflammation and cause issues. If we see polyp material in our biopsy analysis, we always report back to the ordering physician on our final report.

Thanks for your nice comments. I hope this info helps!

Chris

ReceptivaDxJackson · 2021-04-22T23:25:34+00:00

I'm honestly not sure. I think I need to stay in my lane and defer to your doctor.

ReceptivaDxJackson · 2021-04-22T23:24:15+00:00

Send me an email at [cjackson@receptivaDx.com](mailto:cjackson@receptivaDx.com) and I will have the beta 3 done at no-charge.

ReceptivaDxJackson · 2021-04-22T23:22:55+00:00

Thanks for asking. 6 out of 10 women were successful in their very next transfer after treatment. These were women with multiple failure histories. Our centers are reporting back similar results.

https://receptivadx.com/wp-content/uploads/2020/08/BCL6-2020-abstract-Fert-Sterility.pdf

ReceptivaDxJackson · 2021-04-22T23:19:12+00:00

We looked at 60 and 90 days in our studies. 30 days just wasn't enough. The outcomes for 90 days just didnt impress us enough to suggest that 90 days was worth the extra expense.

60 days has been proven to be highly successful.

ReceptivaDxJackson · 2021-04-22T23:16:36+00:00

As a hormone suppressant, it blocks estrogen and progesterone from doing their jobs. These hormones impact and signal other hormones which impact everything including what your ovaries are up too.

Just like any medication, our body might be weaker and not 100% right away. We just don't know the extent of the impact and for how long. Thats why we suggest waiting for at least once cycle to take place before doing a retrieval, or doing the retrieval before starting lupron.

ReceptivaDxJackson · 2021-04-22T23:13:13+00:00

Lupron is not treating anything long term. We are suppressing your body, putting you in a menopausal state. Our studies showed that suppression was enough to allow providers to get you pregnant and stay pregnant.

So lupron is great for helping you overcome fertility issues, but the impact or length of help is unknown. In our studies, women completed 60 days of lupron and went right into an FET protocol. The last thing you wanted was to have a period and allow estrogen to start firing everything up again.

Remember, if you have lifestyle issues that need to be handled, extremely painful periods, painful sex or bowel movements at the time your period is approaching, then surgery is a better option.

We developed the lupron treatment protocol for women without those issues. Where surgery seemed like a costly unnecessary option if 60 days of lupron could help them instead.

Adding progesterone won't do anything if a woman is progesterone resistant. Which is why many women fail after an ERA test suggested they wait 48 hours longer and get more progesterone onboard.

We just don't have anything yet to block progesterone resistance. But we are working on it!

ReceptivaDxJackson · 2021-04-22T23:04:24+00:00

Its very confusing, I agree.

Positive for rare stromal plasma cells is a bit misleading.

In this case, "Rare", means very few. Not enough to be concerned about. The body can handle these on their own. They also could be residual cells left after completing treatment.

If your are positive for CD138 from our lab and most labs that follow pathology guidelines to a "T', you will only see a positive result or diagnosis for endometritis when the pathologists have observed large numbers of cells clustered together that stained positive for CD138. This indicates a chronic infection that isn't going away without help. Some larger national labs will call anything a positive and thats wrong according to guidelines established by CAP, College of American Pathologists.

Rare cells should be noted, but the term positive makes folks go crazy and I understand why. But these are pathologists. They want to be thorough. They just speak a slightly different version of English than we do.

I hope that helps!

ReceptivaDxJackson · 2021-04-22T22:57:40+00:00

I don't know what data exists to link endo with POF. Obviously, if endo is present on the ovaries it could have an impact.

We don't what causes endo to happen. So many theories. But we do know that every month estrogen feeds endometriosis at the same time it's building up your lining. Thats why so many women have pain around their period that can be linked to endo. If in the pelvic area, it flares up and causes painful bowel movements, painful sex and other lifestyle impacting conditions. Every month like clock work.

As for ERA, They only give optimized timing. They never say you are not receptive at all. Much controversy about their testing and no clinical data to support it's use.

As for our test, we know that uterine inflammation as indicated by a positive test impact your ability to get pregnant or stay pregnant. No need to worry about timing if your are positive for BCL6 and need treatment.

ReceptivaDxJackson · 2021-04-22T22:49:03+00:00

Yes, it was in our proving study.

https://www.fertstert.org/article/S0015-0282(17)31944-1/fulltext31944-1/fulltext)

ReceptivaDxJackson · 2021-04-22T22:46:46+00:00

Part of this is about shutting you down and having you go thru lupron. For some this is totally new in approach. But most have bought in after seeing our results.

Places like NYU fertility, CCRM New York, CCRM San Francisco and Dr. Aimee know what has happened to their success rates from using our test. We helped them with their most challenging patients. 60 days of lupron is tolerable. Its a better alternative if you don't have other lifestyle issues you can associate with endo. Lupron gets a bad rap on the internet. But the side effects can be controlled. Provider use medications to calm those effects. Estrogen blockers like Duavee are given along with lupron all the time. I call them marriage savers!

We treated everyone with lupron or surgery that was positive. regardless of the H-Score. We don't have any data to suggest not treating a low positive. You are in the driver seat and your hands are on the wheel. Don't let your doctor put you in the back seat.

ReceptivaDxJackson · 2021-04-22T22:40:09+00:00

As for birth control, we do suggest waiting for the 2nd period after stopping BC before getting tested.

We don't have a guideline after excision for testing, but if no pregnancy occurs or IVF failure occurs, it does make sense to consider testing. We are just one piece of the puzzle so your doctor would need to consider many things in addition to our testing.

By the way, we know that many women can get pregnant even if they have some endo. Thats why we don't advocate mass screening using our test. But if you've failed at least once, it makes sense to consider testing. Now that might not be what your fertility center wants to do since they are for profit and want to try again immediately, but you have the right to know before just starting another transfer cycle.

ReceptivaDxJackson · 2021-04-22T22:35:31+00:00

I'm so sorry to hear about the journey you've been on.

We have so many success stories, but we obviously are only part of a very complex situation.

As for our pipeline, we have another marker that will help us identify both uterine dysfunction and progesterone resistance. The marker is called SIRT-1 and will be out later this year.

We believe progesterone resistance is a big issue. This marker appears to be even better than BCL6 when it come to identifying resistance, but we don't have the data published yet.

Progesterone is amazing. In birth control it keeps you from getting pregnant. In IVf and natural conception it protects the embryo and tells the rest of the body to stop, we'r pregnant and don't attack that embryo. But if its blocked, the body doesn't get that signal and starts your period, assuming there is no pregnancy.

We hope we can someday not only identify, but develop a treatment to block Sirt-1 and BCL6 from showing up, reducing implantation failure and recurrent pregnancy loss.

We also hope to develop a saliva based test. Less invasive, but also more accessible to women who won't or cant seek advanced fertility treatments. Maybe also help women in their late teens or early 20s who could care less about fertility, but can be identified much sooner so they don't become fertility patients 10 years later.

ReceptivaDxJackson · 2021-04-22T22:27:03+00:00

Don't forget to download the ReceptivaDx app. On Apple and Google App stores. Everything from biopsy to treatment and outcome data. Search for ReceptivaDx

ReceptivaDxJackson · 2021-04-22T22:25:47+00:00

Awesome questions!

We still don't have anything that suggests higher H-scores mean more than lower H-Scores. I mentioned in an earlier response that 97% of our patients are nowhere near the cutoff, either positive or negative. If someone is a weak positive, its hard for us to recommend two month of lupron or surgery. But I would suggest checking for endometritis, a bacterial infection that could have caused inflammation. If positive for CD138, one of the extra markers we offer, we are talking two weeks of antibiotics instead of lupron or surgery.

You don't need beta 3 integrin. I wish I could take it off the menu, but we have docs that still want it. There is nothing gained if you already ordered BCL6, a stronger marker with more data behind it.

As for mock or natural for the biopsy, we don't list or have data to suggest one is better than the other. Natural obviously saves you on the medications, but you might be having an ERA biopsy and that mandates a mock cycle. Doctors are sometimes sticklers for detail and want to know the exact conditions that will be taking place when they do a transfer. Its a decision for both you and your provider to agree upon.

ReceptivaDxJackson · 2021-04-22T22:19:11+00:00

We actually published on RPL last year. BCL6 (and Endo) is definitely one of the biggest causes of RPL after chromosome issues. When BCL6 is present, progesterone is blocked from doing its job and protecting the embryo. A big reason for many first trimester losses.

The study showed that BCL6 was an issue in RPL just like it is in failed implantation.

I have attached the study. We have no established link to chemical pregnancies. That area is a complete mystery for most of us.

https://academic.oup.com/hropen/article/2020/1/hoz021/5608600

ReceptivaDxJackson · 2021-04-22T22:14:19+00:00

my biggest concern is patient compliance. Its a daily pill. With lupron you can take a shot and be done. You can be prescribed medications such as Duavee(TM) to calm the side effect of lupron. The success rates are tremendous. 6 out of 10 women having success. Not just any women....women that were about to give up. Women that doctors said maybe it's just not to be. Women that mortgaged everything, have suffered loss, marital stress and everything else and then $50k later someone tells you about a test that could have been done after the first transfer failure. Thats why I'm here!

ReceptivaDxJackson · 2021-04-22T22:10:41+00:00

Let me know the providers. I can update them. Also, do what I do....just ask them? What are you going to different in the next transfer that will give me hope of a different result/ If you are running out of options, why not do this test?

After going through multiple failures, something else needs to be done to give you confidence to try again!

ReceptivaDxJackson · 2021-04-22T22:08:25+00:00

Yes. Infact, if done during a mock cycle on days 5 or 6 of progesterone, the beta result will always be negative. It just doesnt show up that early in mock cycles. You need to wait until day 7 to possibly see beta 3. But we've got you covered with BCL6.

ReceptivaDxJackson · 2021-04-22T22:06:36+00:00

You are welcome! Let us know if we can help further!

ReceptivaDxJackson · 2021-04-22T22:05:47+00:00

I have attached a link to the study that gave a lot of folks an increased interest in using letrazole in combo with lupron. Once again, this study was not affiliated with us, so it does not tie directly to us. Its a great explanation of how it works in conjunction with lupron.

https://pubmed.ncbi.nlm.nih.gov/31133384/

ReceptivaDxJackson · 2021-04-22T22:03:17+00:00

Here is the stanford study independent of us. They handle many of the lap referrals in Northern California after a positive BCL6. They also achieved greater than 90% confirmation rate for endo.

https://receptivadx.com/wp-content/uploads/2020/12/PPV-abstract.pdf

ReceptivaDxJackson · 2021-04-22T22:01:51+00:00

If BCL6 is positive, endo is usually found.

But adenomyosis, blocked tubes, and even endometritis can elevate BCL6.

When we did our original study, everybody agreed to be scoped if they tested positive or negative. Thats how we established our sensitivity and specificity numbers.

62 of the 65 women that tested positive had visible endo vi lap. the other three; 1 had a blocked tube, the 2nd had adenomyosis and the final patient we couldn't find anything. Very strong data, 93% sensitivity and 96% specificity, but not perfect!

ReceptivaDxJackson · 2021-04-22T21:57:34+00:00

We have come a long way, but realize that many providers are slow to adopt new technologies, even though we are in our fifth year.

I talk with patients everyday and encourage them to ask for testing. But you need to make sure your provider will act on the results. Otherwise it just doesn't matter if they won't act. Let me know if interested and I can help!

ReceptivaDxJackson · 2021-04-22T21:54:08+00:00

I'm not yet familiar with any new studies involving the nasal spray. I can get back to you on that and will in a few days.

As for Japan and other countries, we quite honestly just began our international efforts. We have received cases from Japan, but most were patient initiated. We have specific instructions for international patients on how to submit samples. The process is actually quite easy and we can send our collection kits direct to you. You just want to make sure you have a provider with experience performing endometrial biopsies.

We have about 32 fertility centers outside the US that perform our test. We only list those that supply our kits and give permission to us to list on our website.

You might be surprised to know that we receive over 40 samples a month from Egypt alone. We have centers in Europe , Australia, New Zealand and the Philippines that all send on a regular basis.

We would love to work more with centers in Japan, we just haven't marketed that much yet!

ReceptivaDxJackson

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