Over a million reported trades after hours today someone is loading up big time. Think that has something to do with today's rise and hopefully whoever it is keeps on topping up. Looking good for the next few months leading up to the court hearing!
Seems the company has just put up the "For Sale" sign: by stealing a march on its rivals with the new testing system as described (complete with algorithms!) it must surely attract the attention of at least one of the big players. Get the writ trivia out of the way and the blue skies will reappear.
NEW YORK (GenomeWeb) – Premaitha Health has reported that its cell-free DNA-based screen for fetal aneuploidies performed with perfect sensitivity and specificity.
Trisomies 13, 18, and 21 have been increasing in incidence, according to the US Centers for Disease Control and Prevention. But, common screening approaches based on ultrasound findings and other markers have false-positive rates that lead many women to seek an invasive diagnostic procedure like an amniocentesis or chorionic villus sampling when it may not be necessary.
Noninvasive prenatal testing (NIPT) providers — which include Roche's Ariosa, BGI, Illumina, Natera, and Laboratory Corporation of America's Sequenom, in addition to Premaitha and others — say that screening with their tests might bring the numbers of invasive tests performed down by identifying women at the highest risk.
As they reported in Fetal Diagnosis and Therapy this month, Premaitha researchers built an automated next-generation sequencing-based workflow and relied on a cohort of almost 250 high-risk women to develop an algorithm to determine the likelihood of trisomies from circulating fetal DNA. When they gauged their algorithm's sensitivity and specificity on a separate cohort, the researchers reported that their CE-marked in vitro diagnostic test, called Iona, had 100 percent specificity and sensitivity.
"We set out to build a test that could be used by [local labs] and that technicians in two weeks could learn to do genetic testing," William Denman, Premaitha’s chief medical officer said in an interview. "That's why writing this paper was important — to show that we've accomplished that."
Premaitha launched its Iona test in February 2015. Cell-free DNA is extracted from the blood samples and fetal DNA is isolated for sequencing on Life Technology's Ion Proton platform. The results are then fed into Iona's bioinformatics pipeline.
Denman added that the test could be run in a local biochemistry lab without the need for highly trained genetics technicians, and that from extraction to analysis, the test takes three days.
As described in the paper, to develop that screening algorithm, the Premaitha team used a set of 239 samples from women at high risk of trisomies. After excluding four samples — three lacked corresponding invasive diagnostic test results and one was from a woman found to have cancer — this algorithm development set included 36 trisomy 21, 26 trisomy 18, and four trisomy 13 samples.
They tested the model they developed on a separate set of 111 samples, though one sample failed the fetal fraction validity check. They reported that all the Iona-based results matched those provided by amniocentesis or chorionic villus sampling, giving 100 percent sensitivity and specificity.
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