Stratagene deal enters molecular diagnostics market

Molecular testing has improved the process of detecting the presence of agents that cause both viral and non-viral infectious diseases.

Using nucleic acid-based diagnostics for the detection of DNA or RNA, clinical laboratories can deliver results within hours, allowing patients to receive appropriate treatment faster than with traditional testing methods.

The greater sensitivity of quantitative PCR testing methods allows for the detection of microorganisms even when present in very low concentrations.

Under the terms of the agreement, Stratagene​ has granted Focus Diagnostics​ a non-exclusive license to its FullVelocity technology, which Focus intend to develop molecular diagnostics testing kits and products. Financial terms of the agreement were not disclosed.

The FullVelocity technology is a proprietary reagent system for quantitative PCR and QRT-PCR that enables users to make numerous copies of a target, accurately and quickly to detect the presence of specific DNA and RNA in medical specimens.

The technology can be used to identify infectious diseases, cancer, genetic diseases, and drug sensitivities. Stratagene has five U.S. issued patents on the technology with additional patents pending.

"The molecular diagnostics testing market represent a large and growing revenue opportunity. We believe that our technology is faster and more sensitive than competing technologies," said Joseph Sorge, President and CEO of Stratagene.

Additional terms will see Stratagene manufacture the diagnostic products that Focus intends to commercialise globally.

Furthermore, Stratagene will manufacture and sell reagents to Focus for laboratory-developed tests to be used in Focus' national reference laboratory.

Stratagene and Focus Diagnostics enter a market in which the last five years has seen an explosion in the number of applications, molecular diagnostics can have relevance to.

Initial applications of molecular diagnostics were mostly for infections but are now increasing in the areas of genetic disorders, preimplantation screening and cancer.

Genetic screening tests, despite some restrictions are a promising area for future expansion of in vitro diagnostic market.

Molecular diagnostics is being combined with therapeutics and forms an important component of integrated healthcare.

Molecular diagnostic technologies are also involved in development of personalized medicine based on pharmacogenetics and pharmacogenomics.

Currently, there has been a considerable interest in developing rapid diagnostic methods for biowarfare agents such as anthrax.