'Willful Manipulation" Is Charged By Xenomics in Down Syndrome Data

NEW YORK -- Xenomics, Inc. (XNOM.PK), a developer of transrenal molecular diagnostics, announced today that an ongoing internal investigation by Xenomics’ personnel of the events surrounding its licensing deal with Sequenom (Nasdaq:SQNM) in late October, 2008 leads it to conclude that Sequenom purposely misled the Company - fraudulently inducing Xenomics into granting Sequenom an exclusive license to its transrenal technology. Sequenom’s announced success in developing a Down Syndrome test in late 2008 was the principal factor in Xenomics’ decision to exclusively license its core Transrenal DNA and RNA technology in the area of fetal diagnostics to Sequenom.

Xenomics is presently suing Sequenom to recover the Transrenal DNA and RNA technology as well as for specific and general damages.

Events Surrounding Sequenom’s Downs Syndrome Announcement

In September 2008, Sequenom made a «break through» announcement to the medical community and Wall Street that it had succeeded in developing a test for Down Syndrome, using fetal RNA, that had greater than 99% sensitivity and specificity.
The data were presented at an analysts’ meeting by the Senior Vice President of R&D of Sequenom. As a result of this discovery’s importance, Xenomics exclusively licensed to Sequenom its Transrenal DNA and RNA technology in the area of fetal diagnostics for testing in urine .
In January 2009, less than 90 days after signing the agreement with Xenomics, Sequenom announced that it was switching from RNA to DNA and subsequently announced in the spring of 2009 that irregularities existed in data handling for the Down Syndrome test and that the data could not be relied upon. It also announced that a committee of the board had been formed to determine the cause of the data mishandling. In October of 2009, Sequenom announced that the Down Syndrome testing data had been mishandled, though a full explanation has yet to be forthcoming. The company has since fired the CEO, the Sr VP of R&D and other individuals.

It has been reported that the Federal Bureau of Investigations (FBI) as well as the Security and Exchange Commission (SEC) are presently investigating Sequenom and its employees. Xenomics’ personnel have been advised to cooperate with all governmental agencies in the event that they are contacted.

Xenomics Preliminary Conclusions Prior to Discovery Process

Xenomics preliminary investigations prior to the discovery process leads the Company to believe that Sequenom’s Down Syndrome data were deliberately doctored in order to create an extremely robust data set. This announcement also fraudulently induced Xenomics into granting Sequenom an exclusive license to its non-invasive transrenal urine testing technology for fetal testing. Sequenom claims there was no fraud committed, only data mishandling. Xenomics relied on Sequenom’s public statements that they had solved the Down Syndrome testing problem in reaching a decision to grant exclusive license to its valuable technology. In addition, Xenomics has lost valuable time in advancing commercialization of this technology because of the existence of the Sequenom agreement. The Company intends to seek further damages from this consequence.

About Xenomics, Inc., and TrovaGene, Inc.
Xenomics Inc. is focused on the development of DNA and RNA-based tests using Transrenal DNA (Tr-DNA) or RNA (Tr-RNA) and on products for personalized medicine to improve patient care. Its patented technology uses safe and simple urine collection and can be applied to a broad range of applications, including tumor detection and monitoring, infectious disease detection, prenatal testing, tissue transplantation, genetic testing for forensic identity determination, drug development, and research to counter bioterrorism.

The company’s founding scientists were the first to report that fragments of DNA from normal cell death cross the kidney barrier and can be detected in urine. The company believes that its technology will open significant new markets in the molecular diagnostics field. The company has three issued U.S. patents covering different applications of trans-renal technology for molecular diagnostics and genetic testing and a European patent covering prenatal testing applications. Xenomics also has numerous patent applications pending.

Xenomics, Inc.
420 Lexington Avenue, Suite 1701
New York, NY 10170
Contact:
Bruce Huebner, President and CEO, Xenomics, Inc. and TrovaGene, Inc.
bhuebner@xenomics.com
Tel: 1-212-297-0808

This release was published on openPR.