Illumina Files IP Suit Against Ariosa, Roche Over Array-based NIPT

“Illumina has filed a lawsuit against Ariosa Diagnostics and its parent firm, Roche Molecular Systems, for allegedly infringing one of its patents.

Illumina filed its suit Monday in the US District Court for the Northern District of California alleging that Ariosa is infringing its US Patent No. 7,955,794, entitled “Multiplex Nucleic Acid Reactions.” Specifically, Illumina believes that Ariosa’s microarray-based version of its Harmony Prenatal Test is infringing that patent.” Read more.

It’s not clear that this will make much of a difference. The existing patent litigations have been going on for years and everyone seems to be making plenty of money. But now that Ariosa and Natera are owned by deeper pockets, it will be interesting to see how far they are willing to go.

I don’t know, from a technical standpoint, how much more traction they’re going to get on the array based technologies? Does anyone?

Hi-tech blood test for Down’s Syndrome offered on NHS for the first time – and mothers will get the results within days

For the first time women are to get an advanced blood test to detect Down’s syndrome and other abnormalities in unborn babies on the NHS.

The non-invasive IONA test examines DNA in cells from the foetus found floating in the mother’s blood and looks for evidence of chromosomal abnormalities that cause genetic disorders.

It will be offered at in London through the NHS and privately.

Read more.

Illumina Sues Premaitha Health Over NIPT IP

Illumina and its wholly-owned subsidiary Verinata Health have filed a patent infringement suit against Premaitha Health over IP relating to non-invasive prenatal testing, the companies said today.

The suit, filed in the High Court of Justice, Chancery Division, Patents Court in the UK, asserts European Patent (UK) 0 994 963 B2 and European Patent (UK) 1 981 995 B1, both relating to the use of cell-free fetal DNA for NIPT.

Illumina licenses the patents exclusively from Sequenom and Stanford University. Stanford joined the suit because it is the registered owner of the ‘995 B1 patent. Read more. 

Study reports high rate of chromosomal abnormalities in patients in whom NIPT fails to provide results

In a study to be presented on Feb. 6 in an oral concurrent session at 1:15 p.m. PST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in San Diego, researchers will report on the high rate of chromosomal abnormalities in patients in whom noninvasive prenatal testing fails to provide results.

Noninvasive prenatal testing has become popular with many physicians in screening pregnant patients. The study, titled Chromosomal Abnormalities Detected in Patients with Failure to Obtain Test Results Using Non-invasive Prenatal Testing, looked at noninvasive prenatal tests in a total of 4,446 pregnancies. The tests were performed from October 2012 to June 2104. High risk women were offered noninvasive prenatal tests per the American Congress of Obstetricians and Gynecologists guidelines and tests were done at an outside laboratory. Results were reported as “low risk”, “high risk”, or, if no result was obtained, as “redraw request.” The incidence of chromosomal abnormalities in the RR group was compared to the entire cohort.

Read more.

DNA Blood Test Gives Women A New Option For Prenatal Screening

When Amy Seitz got pregnant with her second child last year, she knew that being 35 years old meant there was an increased chance of chromosomal disorders like Down syndrome. She wanted to be screened, and she knew just what kind of screening she wanted — a test that’s so new, some women and doctors don’t quite realize what they’ve signed up for.

This kind of test , called cell free fetal DNA testing, uses a simple blood sample from an expectant mother to analyze bits of fetal DNA that have leaked into her bloodstream. It’s only been on the market since October 2011 and is not regulated by the Food and Drug Administration — the FDA does not regulate this type of genetic testing service. Several companies now offer the test, including Sequenom and Illumina. Insurance coverage varies, and doctors often only offer this testing to women at higher risk because of things like advanced maternal age.

Read more.

Sequenom, Cypher Genomics Partner on NIPT

Sequenom and Cypher Genomics have struck a development agreement for noninvasive prenatal testing, the companies said today. Sequenom will use Cypher’s genome interpretation technology, Mantis, to analyze clinically relevant fetal sub-chromosomal variants detected in maternal blood.

Sub-chromosomal variants are often not detected until after birth and they make up more than 50 percent of rare chromosomal abnormalities beyond the more common aneuploidies and are associated with morbidity and mortality risks.

Read more.

To NIPT or Not to NIPT? That Is the Question

There are many conversations had between an expectant mother and her prenatal care provider — for the most part, these are positive in nature and revolve around ensuring the health of both the patient and her unborn child. However, for every positive conversation, there is one a bit heavier in subject matter, one often discussed and debated amongst the medical community, between a woman and her partner, and doctor to patient — the screening and diagnosis of fetal genetic disorders and which course of action be followed.

All parents want the best reassurance for their pregnancy and to protect their unborn to their greatest capability. What is imperative is that a woman understands her options concerning prenatal testing and the risks and benefits inherent in each. In most cases, a woman has elected for testing after discussion with her provider, secondary to a sonogram that presented concerns indicative of an issue, or when another factor, such as familial or maternal medical history is in play.

Read more.

NIPT Landscape Shifts in 2014 as Providers Transfer Technology, Plan IVDs

NEW YORK (GenomeWeb) – Noninvasive prenatal testing continued to expand in 2014 and is poised to move from high-risk to average-risk pregnancies in 2015. Last year, a global diagnostic player entered the field, new laboratories in the US and abroad launched NIPT services and several providers announced their plans to develop in vitro diagnostic NIPT kits.

Entering 2015, the landscape of NIPT providers and their alliances has shifted from a year ago. Overall, the global market continues to be dominated by four US-based companies – Sequenom; Illumina; Ariosa Diagnostics, which is in the process of being acquired by Roche; and Natera – as well as two players based in China, BGI and Berry Genomics. Almost all of these currently offer NIPT as laboratory-developed assays, though some have started to transfer their testing technology to other labs and some are working on IVD kits. BGI is the only provider so far to have obtained regulatory approval for its test, from China’s Food and Drug Administration.

New to the scene are LabCorp in the US, which last year launched a NIPT based on Illumina technology, and Premaitha Health, a UK-based firm developing an IVD test. Local diagnostic laboratories in several European countries have started to launch their own tests, in some cases transferring technology from Illumina or BGI. They are joining LifeCodexx, an early NIPT adopter based in Germany.

Read more.

Prenatal testing to detect genetic flaws to be launched (in India)

NEW DELHI: Now, it may be easier to detect and prevent the birth of children affected with chromosomal and genetic disorder, which account for 30-40% of mental and social handicaps. A revolutionary screening method — non-invasive prenatal testing — is set to be launched in India later this week which will allow safer and definite detection of such disorders in pregnant woman.

Chromosomal and genetic disorders cause severe problems such as mental retardation, heart and intestinal diseases. Of these, Down syndrome is the commonest, say experts. Currently, the incidence of Down syndrome is 1:800, which means approximately 32,000 babies with Down syndrome are born every year (the birth rate of India is 25.6 million births).

A new study, conducted at Sir Ganga Ram Hospital in New Delhi, showed that non-invasive prenatal testing qualifies as an “advanced” screening test. The study, conducted to assess the utility of the test, also depicts it as a safer screening option as compared to existing testing methods which have a risk of abortion. The test was offered to 500 pregnant women during the study.

Read more.

A Crowded Field for Noninvasive Prenatal Screening Tests

Growing market expected to reach $3.6 billion by 2019.

Patricia Fitzpatrick Dimond, Ph.D.

Prenatal screening for detection of a wide range of monogenic disorders and chromosomal abnormalities has been available to prospective parents for over 40 years. But these screening techniques, including seroscreening and ultrasound, have false positive rates of 5% and 10–15%, respectively, requiring that 1 in 20 women face a decision of whether to undergo invasive testing that may include amniocentesis, chorionic villus sampling, or, rarely, cordocentesis.

All of these procedures involve some risk with fetal loss rates of approximately 1 in 300 procedures, according to the American College of Obstetricians and Gynecologists (ACOG).

But the discovery of circulating fetal DNA (cfDNA) in the maternal circulation and the development of advanced sequencing technologies have led some scientists and clinicians to predict that antenatal diagnosis will become a predominately noninvasive process that will usher in the era of noninvasive prenatal testing (NIPT).

Read more.