The story is on the front page of the Marketplace section.
The Food and Drug Administration, which has been reviewing a proposal to regulate some high-risk tests, has asked SQNM more information on their products. The Journal quotes Center for Devices and Radiological Health's Office of In Vitro Diagnostics Director, Dr. Alberto Gutierrez, as saying, the FDA wants to "make sure the performance of the test is good so people can make the decisions that they're going to make."
Sentiment: Strong Sell
There is no where in the WSJ piece that says that the FDA asked SQNM for more information. What you have written is so obviously slanted that anyone who actually read the article would be hard pressed not to consider you a liar.
Sentiment: Strong Buy
Looks like they are way ahead of everyone:
"...Currently, we are primarily focused on expanding the commercial use of and reimbursement for Sequenom CMM's prenatal LDTs that use our foundational, patent-protected, noninvasive, circulating cell-free fetal, or ccff, nucleic acid-based assay technology. This technology, which we in-license from Isis Innovation Limited, or Isis, uses a maternal blood sample for a prenatal diagnosis or risk assessment in order to provide reliable information about the presence, amount, or absence of fetal genetic material in early pregnancy. We have branded our technology for ccff nucleic acid under the trademark SEQureDx. We currently plan to execute the development, validation, and other activities necessary to file applications with the U.S. Food and Drug Administration, or FDA, seeking clearance or approval for commercialization in the United States of certain of our in vitro diagnostic tests where we believe it will afford us competitive advantages to do so, such as providing us with the flexibility to sell the tests as FDA cleared or approved in vitro diagnostic, or IVD, kits to other laboratories, and an alternative in the event the FDA decides to exercise its enforcement jurisdictional authority with respect to regulation of laboratory-developed tests as IVDs. Historically, the FDA has not exercised enforcement discretion and exempted from regulation LDTs, but the FDA has stated that additional regulation of LDTs may be warranted. In 2010 we submitted a pre-investigational device exemption, or pre-IDE submission and supplemental submissions in 2011 and 2012 to the FDA for an IVD test for fetal chromosome aneuploidy, such as trisomy 21, and have met with the FDA to discuss our proposed preclinical and clinical study designs. Patient enrollment has been initiated for these clinical studies."
"Looks like they are way ahead of everyone:"
SQNM is way ahead in documented quality/reliability of their tests and this FDA action may put the pretenders out of the biz. There is really no comparison between the test offered by SQNM and the pretenders, regardless of IP status.
I think I posted 3 years ago saying this product looked like a medical device for approval/marketing purposes. If FDA decides the device classification is more appropriate then SQNM needs to provide a bunch of paperwork assuming that product development followed best practices. Don't know if FDA would grandfather prior approvals. I don't have any inside info but should be aware that if it happens then it results in increased costs and delays.
To delay something you have to stop it BEFORE it goes to market. Read the last sentence...
In a report published by Wedbush Securities, analyst Zarak Khurshid upgraded Sequenom (NASDAQ: SQNM) from Neutral to Outperform and maintained a $5
In the report, Wedbush noted, "We suspect that yesterday's ~5% selloff was partially due to a leaked WSJ article, which included comments from the FDA around a proposal to regulate new prenatal screening tests, that has been in the works for two years and is under "administrative review". In addition, a quote in the article from the FDA's head of diagnostics read “We have been trying to plug some of the regulatory gaps.” Both the WSJ article and a recent piece from Genomweb recapping a talk from the ACMG meeting on 3/23/13, highlighted cases of false positives which have helped to reignite fears around FDA regulation, in our view. Due to the rapid pace of adoption and complexity (four existing players, ACOG guidelines endorsement) we believe the FDA has missed its window to regulate the non-invasive prenatal testing market, thus reducing the risk of disruption."
I'm glad the FDA ask. That way those others who we already know have high no call rates will be placed on notice by the FDA. When you have the Cadillac like Sequenom does your not afraid to get FDA approval.
Sentiment: Strong Buy