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Daniel MacArthur
I write about the genetic and evolutionary basis of human variation, and the companies trying to sell you information about your genome.

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Sequenom reveals prenatal Down syndrome test data are "questionable"

Category: pre-natal genetic diagnosis
Posted on: April 30, 2009 12:20 PM, by Daniel MacArthur

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.

GenomeWeb Daily News reports:

As of early February, Sequenom had released data on its SEQureDx test from a total of 858 samples. It said that the positive predictive value was 96.6 percent, and the negative predictive value was 100 percent. But, the firm can no longer rely on that data.

"We are confident in the assay performance," [Sequenom CEO Harry] Stylli said during the call. "It's fair to say that the high-level clinical performance that we've disclosed to you is questionable."

Stylli said he was limited in what he could say in response to questions about the incident, due to confidentiality agreements and the investigation. "The data in question relates to data that goes back to June -- the September and January releases of information -- I believe that information is now suspect ... I can't really go into any of the details because of the confidentiality considerations and because the investigation is not complete," he said.
Here's Sequenom's share price over the last five days:

sqnm_5day_nasdaq_090430.jpg



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Comments

1

Not good for SQNM. But I thought they've been seeing good data for more than the past 6 months (though last year's data was in a small sample). I wish the report had more information--if the test is still good, then this is just bad for their credibility but hopefully shouldn't hurt them in the long run. Really wish there were more details available.

Posted by: Jessica | April 30, 2009 1:29 PM

2

Wait never mind. I just read the press release on the company website and they are saying that all data released thus far about the DS test are in question.

Posted by: Jessica | April 30, 2009 1:41 PM

3

Stock's going "down syndrome".

Lot of companies caught that bug lately.

Posted by: anomalous | April 30, 2009 1:58 PM

4

It would be interesting to see who sold shares in the months before they released that information.

Posted by: Adam M | May 5, 2009 10:18 PM

5

You can look up online who among the officers sold shares...The VP of prenatial dianostics sold $300K of shares at the end of March.

As far as I can tell from the site, no other officer ever sold nearly as many shares in years.

Posted by: swbarnes2 | May 8, 2009 5:02 PM

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