Public Release: 

Third Wave scientists publish advance in gene expression monitoring with revolutionary RNA Invader® Assay

Feinstein Kean Healthcare

MADISON, Wis. - July 2, 2001 - Scientists at Third Wave Technologies Inc. (Nasdaq: TWTI) have validated a technological breakthrough with the potential to revolutionize the analysis of gene expression for research and clinical applications including genome research, drug development and disease monitoring.

Third Wave's Invader technology is capable of identifying and quantitating low levels of unique RNAs directly from total RNA or crude cell samples called cell lysates, according to findings published in the July issue of Nature Biotechnology. Direct detection of gene expression levels with Invader technology eliminates several costly, time-consuming steps required by other technologies and minimizes the risk of sample contamination.

"The ability to analyze for RNA easily and directly, without complicated procedures that can contaminate the sample, is a significant advance in RNA detection technology and the efforts to understand diseases and develop drugs to treat them," said Lance Fors, Ph.D., president and chief executive officer of Third Wave Technologies.

Key Findings Reported in Nature Biotechnology: RNA Invader Assay

  • Direct Detection. The RNA Invader assay enables identification and quantitation directly from total RNA or crude cell lysate samples prepared using a simple and inexpensive process. Many RNA tests require high-purity RNA purification, often in combination with time-consuming and expensive multi-step preparation of the RNA samples before they can be tested. A method known as RT-PCR is among the most commonly used. It includes RNA purification, transcription of the RNA to its DNA complement and creation of additional copies of the DNA again and again prior to detection. RT-PCR methods are inherently less accurate than direct RNA detection and test results can be skewed by sample contamination.
  • Accuracy and Precision. The RNA Invader assay is capable of detecting changes in gene expression levels as small as 1.2-fold or 20 percent, allowing researchers and clinicians to routinely and precisely quantify small but important changes in biologically and medically significant genes.
  • Sensitivity. While the RNA Invader assay can routinely and directly detect as few as 6,000 copies of RNA, a level sufficient for monitoring gene expression, an analytical sensitivity of fewer than 100 copies of HIV-1 RNA was demonstrated.
  • Specificity. The RNA Invader assay not only clearly distinguishes between RNA sequences that are more than 95 percent identical, but can detect the equivalent of a single target sequence in a pool of at least 20,000 sequences of closely related RNA. The majority of existing RNA testing methods have difficulty discriminating between highly similar sequences and, as a result, cannot consistently identify and measure a specific target within a sample of closely related RNAs.
RNA is the body's medium for translating an individual's genetic blueprint, found in one's DNA, into all the proteins in the body, including those that fight disease, metabolize drugs and perform a host of other critical functions. Many gene families, like the important cytochrome P450 family responsible for metabolizing drugs and toxic compounds, generate nearly identical RNA sequences that produce proteins with different functions and effects on the body. The Invader assay's ability to discriminate between nearly identical RNA sequences allows researchers to identify a specific RNA target with consistency, accuracy and precision.

The ease and accuracy in measuring gene expression provided by the RNA Invader assay are vital to accelerating research to understand disease progression and develop new drugs. The assay's ability to detect low levels of RNA also provides potential for first detecting and then monitoring the treatment of infectious diseases like HIV more quickly than now possible.

The Invader technology will ultimately allow health care professionals to personalize diagnosis and treatment of disease based on the unique genetic make-up of each patient.

"The true power of the RNA Invader assay is the coupling of its accuracy, precision and sensitivity with its ease of use and versatility across a number of existing instrumentation platforms," Fors said. "The RNA Invader assay's characteristics make it ideal for the high-volume gene expression monitoring needed for genome research and drug development and open a large, existing market to Third Wave."

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The authors of the Nature Biotechnology paper are Third Wave scientists Peggy Eis, Marilyn Olson, Tsetska Takova, Michelle Curtis, Sarah Olson, Tatiana Vener, Hon Ip, Kevin Vedvik, Christian Bartholomay, Hatim Allawi, Wu-Po Ma, Jeff Hall, Michelle Morin, Victor Lyamichev and Robert Kwiatkowski and Tom Rushmore of Merck Research Laboratories.

Third Wave is a leading developer and provider of DNA and RNA analysis products for use in genome research, pharmacogenomics and clinical applications. For more information on Third Wave and its products, please visit Third Wave's website at www.twt.com.

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934 as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for Third Wave from those projected. Those factors include risks and uncertainties relating to technological approaches of Third Wave and its competitors, product development, manufacturing, market acceptance, cost and pricing of Third Wave products, dependence on collaborative partners and commercial customers, successful performance under collaborative and commercial agreements, competition, the strength of the Third Wave intellectual property, the intellectual property of others and other risk factors identified in the documents Third Wave has filed, or will file, with the Securities and Exchange Commission. Copies of the Third Wave filings with the SEC may be obtained from the SEC internet site at www.sec.gov. Third Wave expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Third Wave's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. Third Wave Technologies, Invader and the Third Wave logo are registered trademarks used by Third Wave Technologies, Inc.

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