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in their own words: the real Sequenom story from April 2009

so I finally ran across the Sequenom, Inc. Q1 2009 Earnings Call Transcript from April 29, 2009 via another Google Finance Discussion message.  first and foremost, it looks like the SEC investigation may not be as bad of an omen as i’d initially thought..

We have alerted the SEC and we will keep them apprised of our actions. We have also informed the FDA and will continue to follow any recommendations they may have for us.

but on the other end of things, parts of this discussion between director, president/ceo, and cfo of sequenom with a bunch of analysts.. are rather amusing

Bob HodgsonBlackRock, Inc.

Maybe I guess as part of your investigation, clearly these people, these four people, one or more of them had some kind of financial incentive to falsify or otherwise quote mishandle the data. The question is what the ties are there and trying to figure out how much money you guys are going to burn. In fact, you may in fact have some liability on this with respect to if there was any patient activities that were based upon the results of these tests.

Harry Stylli

I believe you are speculating. Okay? On both the employee aspect as well as the patients. No data was revealed to patients. For example, we were in a clinical study mode where the patient identity is blinded. The information is not used for that patient. Patients were simply supplying us with a tube or two or three of blood anonymously, okay? Now as to the other points that you are trying to get to, again, I don’t want to reiterate this, but really I believe a lot will come to light once the independent committee concludes its actions and reports.

feelings are hard to figure out in text, but a response like that clearly shows the guy flustered.

but in general, looks like they’re looking for about a 1000 new samples (or were at that point, who knows what’s going on now), and are attempting to validate their trisomy 21 test by looking at more markers, with a commercial test aimed at being released Q4 of this year. hmm… let’s see what data you have in your peer-review submissions first…

the analysts continue to harass and get the truth out…

Jerry KalmatosTrifund

Yes. Hi. Thanks for taking the question. My question surrounded similar questions from before. You really didn’t answer them but most of the data, would you used the word “mishandled”. Would you say that “falsified” is too strong a word? Were there mistakes made scientifically on the assay part of it? Or do you think data was falsified on purpose? What exactly do you think happened?

Harry Stylli

I would like to answer those questions, but again, I have got to respect the other committee until it concludes its analysis.

and, as an ending note, before my 400 word limit copyright issue thing expires.. looks like they still have their original goals in mind, which is still, in my mind, ridiculously cool, if it works, and if its more accurate at diagnosis than screening:

Harry Stylli

We are actually very confident about our core technology. And we just believe we have had a little setback here. We always like to leave the door open to interesting ideas. We are interested in developing noninvasive prenatal tests or diagnostics irrespective of the technology type. But I want to reiterate that we are very confident about the potential of our core cell free fetal technology.

sure sure. it may not be truly “diagnostic” in the way medical professionals think diagnostic, but if it exists as an unhappy medium between AFP screening and prenatal diagnostics, its still another medium, another option, and more options aren’t always a bad thing.

shoutout to Seeking Alpha for providing the transcript. link to the original page is up top.

another Sequenom update

more trouble seems to be brewing. bubbling. well, more like simmering… in the Sequenom part of the DTC world.

a reported 80% drop in the Sequenom stock over the past half year, sucks for them, most of which happened back in April i’m assuming. such an unfortunate loss of momentum, and the most recent inquiries into Sequenom…

Sequenom disclosed in a filing with the US Securities and Exchange Commission Tuesday that the SEC is investigating the firm over its announcement in late April regarding the mishandling of R&D test data and results for its SEQureDx Down syndrome test.

they say this is to be expected. i, on the other hand, know little abotu the SEC. but as i guess is appropriate, this reflected another drop in shares. starting the 2nd half of 2009 with the same bang as the first half eh?

they state their willingness to cooperate… of course you’re going to cooperate. what if you didn’t? well, where would your credibility be?

The filing does not detail the SEC’s concerns, but Sequenom said that it intends to “cooperate fully with the SEC in this matter.” It added, “Our internal investigation is ongoing.”

so no news of what’s happening to SequreDX. ongoing internal invetigations. i’d hope they’re trying to figure things out given this and their recent shareholder class-action lawsuits..

come on Sequenom, your noninvasive prenatal diagnostics train had been running so smoothly until 2009 came around. regardless of how accurate or what ethical issues these “diagnostic” tests raised, it was still promising technology that would surely promote refinements and public discussion…

read about it at the following and above links:

http://www.genomeweb.com/dxpgx/sec-investigating-sequenom-over-down-syndrome-test

UPDATE:

so it sounds like while SequreDX is being put on hold, their CF, XY and Rh tests will start being released over the next few months. let’s see if that boosts your self-esteem a bit..

http://www.mlive.com/business/west-michigan/index.ssf/2009/07/sequenom_still_plans_expansion.html

heard through:

http://finance.google.com/group/google.finance.664159/browse_thread/thread/f7382fe18ddc2224

also, sounds like their Grand Rapids, MI labs will be expanding..  and they’ll be submitting (?) some prelim trial results to a peer-reviewed journal. hmm… what’s this all mean.. other than a 10% stock increase just today?

http://finance.google.com/group/google.finance.664159/browse_thread/thread/c05e16c0fab7dfea/de094a19c23de748#de094a19c23de748

hmm.. now, what I want to know is who is this jjuless person that been spamming google finance’s SQNM page with all this “good” sequenom news…

as the Sequenom wheel turns.. o

so subscribing to GenomeWeb Daily News on my fancy shmancy Google Reader is awesome because I get to hear all the updates right away! on that note, things about Sequenom always seem to catch my eye. today, apparently…

Shares of Sequenom soared in Tuesday trade, even though there appeared to be no news that would create such a surge in both its price and trading volume. Sequenom finished Tuesday up 58 percent at $5.30 on the Nasdaq. More than 53 million shares traded hands on the day — nearly 10 times its average daily trading volume.

makes you wonder, what’s going on dudes?

http://www.genomeweb.com/dxpgx/sequenom-shares-rise-sharply

Categories: publicity Tags: ,

SEQureDX troubles?

Oops.. I was so excited for SEQureDX too, I was really hoping it would have some clinical utility. Considering I’ll be premising my research on the idea of noninvasive prenatal diagnostics. Hopefully the kinks can get worked out, but nevertheless, it really is just a screen, right?

http://scienceblogs.com/geneticfuture/2009/04/sequenom_reveals_prenatal_down.php

“For those who have been too distracted by swine flu to notice: shares of the biotech company Sequenom have plummeted by 77% after the company announced that the extremely promising initial results for its SEQureDx Down syndrome test – which is designed to detect Down syndrome fetuses using blood samples from pregnant women – were “questionable” and had been mishandled by employees.”

http://www.genomeweb.com/dxpgx/sequenom-discloses-mishandling-test-data-shares-plummet