Dear Wiscoy Forum Members:

Well, here I am again, hat in hand, asking those of you who have purchased genetic tests from InGen for continued patience and to explain why we are having such a hard time getting you your test results. First, for those that may not be familiar with me, my lab and our history here on this forum, I am the general manager and CEO of International Genetics, Inc in Freeport, Bahamas. Many of you have purchased products from us and are awaiting results. Some have been waiting a ridiculously long time. I posted a letter here a couple of weeks ago explaining what our problems were at that time. Since then, we have been experiencing other problems that have plagued us and kept us from finishing our testing obligations. I am not offering up excuses here, we are terribly behind in our processing schedule. But I do want to explain the situation we have been dealing with.


Somehow, we got aerosol contamination in the Freeport lab which contaminated all working surfaces, much of our assay, reagents and plastic consumables needed to process samples. The contamination was a result of amplified DNA that was inadvertently released by a ruptured reaction plate in our RTPCR instrument. Amplified DNA is a by-product of the testing procedure (the end product being the results). If not properly contained, amplified DNA can become airborne and billions of DNA molecules can attach themselves to various surfaces. Well, this is what has happened. The amplified DNA went airborne and basically contaminated the entire lab. The amplified DNA, which is invisible to the naked eye, contaminated fresh reaction plates which is where test samples are mixed with assay & reagents and then placed into the RTPCR instrument for processing. It also contaminated our supplies of sterile lab water & reagents. When processing tests, there must be a control sample which is needed to establish a baseline for gauging the other results. This is similar to a drug test where you have a certain amount of people taking the real drug and another group taking a placebo. We call these control samples Non-Template Controls (NTC). When we have a successful test run, the actual samples are supposed to amplify and the NTC’s are not. Once amplified, we can determine if a sample is Positive, Carrier or Negative for the particular test. With the contamination, the NTC were amplifying because either the reaction plate or the reagent was contaminated with the amplified DNA that was previously released. And our processing has been failing. Unfortunately, the only way we can find problems is through trial & error. It took several tests to find out what the actual problem was. And potential fixes take time because at the very least, it takes a week to order the necessary supplies and get them delivered to Freeport. So it has basically taken us 2 weeks to fix this problem. But the good news is we have identified and hopefully fixed this. We have purchased completely new assays, reagents, controls & consumables. And we are in the process of completely sterilizing the lab. If all goes according to plan, we should be back testing this weekend, maybe sooner. We are also installing a PCR Laminar Flow UV Hood where this will not happen again. All of this did not come cheap but it is being done.

As a customer, I know you just want what you have paid for and expect your results in a timely fashion. Believe me, all of us here at InGen realize this and have been agonizing over these continued delays. As frustrating as I know it is for you, our customers, not to be getting your results, it is equally frustrating and painful for us not to get them out to you. We know our reputation has been killed here. Our sales have dropped by 50% over the last month. We were just beginning to become profitable when all these problems began to occur. So please know these issues are causing us great financial pain. I want nothing more than to fulfill InGen’s obligations and get these outstanding tests processed and delivered as fast as possible. Another thing to please keep in mind: although most of the email and other messages we have been getting have only dealt with the delay problem, “WHERE ARE MY RESULTS!!!” type of comments, we have gotten a few accusing us of nefarious and basically criminal behavior. I have been copied with a few posts from various forums with the accusations. I feel as though I must respond. It would be easy for us to just post a test result, any test result, to ease the pressure we are under to get our backlog processed. Given that, for pra-PRCD for instance, about 85% of all dogs tested for this disease come back negative, we could just post negative results and temporarily satisfy some customers. Eventually that would catch up with us when some customers would begin to throw affected puppies. But it would quell the dis-satisfaction for the moment. THAT would be nefarious and criminal. Although I have personally invested a tremendous amount of money in InGen and its ongoing legal battles (I FEEL the pain), I would never stoop to such unethical behavior. So these accusations are completely unfair and unwarranted.

We are still in business and we will get through this difficult stretch. I know many of you have had your patience stretched beyond the breaking point with us. But our problems have been almost exclusively related to turn around time. Very few, if any, customers complain about our results. Once we get our current lab problems resolved, InGen will develop a method to show what our actual turnaround times are. And we WILL get our TAT to less than 3 weeks from sample receipt. That is our absolute ultimate goal which we are working very diligently to achieve.

Thank you for giving me your time in reading this. Please feel free to contact me at rick@ingen.bs with any comments or complaints. I take full responsibility for everything that occurs here at InGen.

Rick Dobbins

Rick, you are certainly well spoken, however, the question still remains ... when can we expect our RESULTS? Many breeders (myself included) are trying to make breeding decisions and if we could at least have a *real* timeframe we could at least move forward with out planning.

If our new supplies arrive in Freeport tomorrow (Thurs)as expected, we hope to get at least 100 tests processed then and 100 a day for the next week. I will post something here tomorrow to give you an update on our progress.

Thanks...Rick Dobbins

I think it's time to give refunds.

Agree 100% with Stacey!

No laboratory conducting molecular diagnostic testing would operate in a single room such that contaminatinon of this sort would even be possible. Who is your laboratory director and has he/she ever worked in a molecular laboratory in the US? There are standards of practice that even the most basic research labs use. There is ALWAYS unidirectional work flow and segregation of pre-amplification and post-amplification product.

Let me guess the next bit in the saga. The swabs and hair follicles that had not been extracted yet were also contaminated and everyone will have to send new samples in?

I hope you bought a few laminar flow hoods and find it hard to believe any scientist would not be using one for PCR from the beginning! Wow.

"We are also installing a PCR Laminar Flow UV Hood where this will not happen again. All of this did not come cheap but it is being done."

Ummm - don't you think you should have taken standard precautions and procedures BEFORE you started taking people's money? Yeah - doing business the right way is expensive, especially if you've pissed off most of your customers who were willing to give you a break for awhile.

BlahBlahBlah - hard to believe anything that is said by Ingen any more!

Our Freeport Lab was set up under the direct supervision of the staff of the Animal Genetics Lab at Texas A&M University. You can contact them at 979-845-6524 with any questions concerning how we set the lab up. This lab had been working without contamination issues quite well without a hood for almost a year. Yes, I wish we had installed a hood sooner, it would have eliminated this problem.

-Rick Dobbins

I find it hilarious that some of you are willing to bad mount Ingens attempts fix mistakes.

Have you all forgotten the crap Optigen put us through years ago???
Perfectly good dogs were discarded from breeding programs due to HUGE mistakes with their testing, but I guess since they had a decade to fix their problems they are now forgiven and still make us pay dearly for it.

if your breeding program is teetering on the edge of one test results you have bigger issues and need to re think your process.

At last! Someone with a little common sense.

Thank you! OptiGen didn't give us so much as a "gosh, we're sorry" when their messes resulted in the elimination of many lovely dogs from the gene pool. At least Ingen has been up-front with explanations, admitted mistakes, and apologies.

I have to say that I agree with the comments about Optigen. Cut Ingen some slack guys, they are trying & we are being kept up to date on the issues. Sounds like Rick is doing his best to keep everyone in the loop. Most companies would stay quiet and not address us on a group level, takes some courage to speak up on a forum such as this one.

Love it! Thank You, Very good point seems we forget to fast about what the other did. Know your lines..

Optigen said right up front that it was a "marker test" and said there would be false positives until they found the actual gene. Yes, I had some come back as carriers that weren't but I didn't jump the gun and discard them. I bred accordingly. Optigen later updated their status as the test improved. I didn't have to request it, the new results were sent to me. I trust Optigen's quality control.

When you make a purchase, you expect the product to live up to its expectations. For example, many people like myself bought a kit from Ingen for test s results including PRA, coat color and long coat gene, to find out in July/August that the color test would not be available . Ok, so Ingen offers to replace that test with an EIC test for the inconvenience. Great, wonderful customer service. So you wait. And you wait. And 3 MONTHS go by with no test results. Its excuse after excuse, promise after promise.

For example, here on this forum on October 20, Rick posted "Those of you who are waiting on results sent in August & September should be getting an email from us this week alerting you that the results are now available on-line in your customer portal."
http://pub12.bravenet.com/forum/static/show.php?usernum=976632990&frmid=4&msgid=815976&cmd=show

Well guess what, its Nov 11 and tests submitted in August are still not available. In this day and age, breeders have more options (then compared to 15 years ago). Other companies are producing results in a timely manner, without all these issues. DDC for example can give you color coat results and EIC results in 10 days or less. So why would it be advantageous for me to continue to wait for Ingen to get their act together? Sorry, but I can't come up with a good reason

Bottom line. I won't need a PRA test for months. I hope these folks get their act together by the time I want to test one of my dogs. If they can get it together, the fact that their prices are more reasonable will mean more people will test. That will be a good thing.

Hello Everyone,

I promised I would update all of you as to InGen's progress to fix its contamination issues and get our back log of samples processed. Well it has been 3 days since I posted why long explanation of issues/problems and wanted to let you know where we are. We were unable to process anything until today. And although the raw data looks MUCH better, we were unable to make any result calls. This seems due to a software issue that we think our PhD can tweak and make our RTPCR system give the proper call. So I certainly hope to be able come here early next week and give some good news. I will post here with good or bad news.

Thanks and have a great weekend!

Rick Dobbins