2013 10K Page 5
If we cannot obtain licenses to patented genetic markers and genes relevant to our diagnostic areas of interest, we could be prevented from obtaining significant revenues or becoming profitable.
The USPTO has issued patents claiming single SNP and gene discoveries and their related associations and functions. The law is evolving and the validity of those types of patents has been and continues to be unclear. If certain SNPs and genes are patented, the validity of such patents types of patent is unclear and it is uncertain whether we may need to obtain rights to those SNPs and genes to develop, use, and sell related assays and other types of products or services utilizing such SNPs and genes. Required licenses may not be available on commercially acceptable terms. If we were to fail to obtain licenses to certain patented SNPs and genes claimed under valid patents, we might never achieve significant revenues from our diagnostic product development.
If the medical relevance of SNPs or other genetic variation is not demonstrated or is not recognized by others, we may have less demand for our products and services and may have less opportunity to enter into diagnostic product development and commercialization collaborations with others.
Some of the products we hope to develop involve new and unproven approaches or involve applications in markets that we are only beginning to explore. They are based on the assumption that information about genes and SNPs may help scientists better understand conditions or complex disease processes. Scientists generally have a limited understanding of the role of genes and SNPs in diseases. We cannot be certain that genetic information will play a key role in the development of diagnostics or other products in the future, or that any genetic-based findings would be accepted by diagnostic, pharmaceutical, or biotechnology companies or by any other potential market or industry segment. If we or our customers or collaborators are unable to generate valuable information that can be used to develop diagnostics or other products, the demand for our products, applications, and services will be reduced and our business will be harmed.
Dirk van den Boom Feb-2014 page 7
Well, this is Dirk. These are multiple of question. I'll try to pick them of, I think to address maybe the first part of your question, we have said that in all previous calls, we always had an alternative technology program and what you see this year is that obviously in that program we had multiple successes, which we are considering could be very good options for a lower cost test for the market segment we are talking about. And we are very confident in that, I think it's too early to talk about how that exactly looks like in terms of what we want to disclose publicly. But we will follow the same principles we have done in the past. We are running clinical samples we will produce adequate data and then we'll be in a position to talk about just to address the procedures we have.
2013 10K Page 41
Separate from Sequenom Laboratories, Sequenom Inc. is currently in the process of planning and preparing for the development, validation, and other activities necessary to file a marketing application with the U.S. FDA seeking approval for commercialization in the United States of an in vitro diagnostic, or IVD, NIPT test for chromosomal abnormalities associated with trisomies 21, 18, and 13.
Disclosure: The author is long SQNM.