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Applied Clinical Trials

Third Wave Technologies' Invader,? MDS Pharma Services' Centralized ECG Service,? and Covance's StudyTracker?

Two diagnostic companies with specialties in minute technologies join together for big time savings

Third Wave Technologies' (Madison, WI) Invader uses DNA and RNA analysis tools to search the double-helixed chains of the building blocks of life.

While the process was streamlined, the necessary liquid-handling stages were time-consuming.

That time can now be freed up, thanks to a supply agreement Third Wave made with 3M's (St. Paul, MN) Bioanalytical Technologies Project. 3M has developed microfluidic technology, which can reduce the amount of machinery needed by improved routing of interconnects. The end result will speed up the process without sacrificing the results.

The five Invader test fields will still be available: chromosomal analysis, infectious disease pharmacogenetics, hpv/women's health, and genetics. Leading tests include cystic fibrosis screens and diagnosis, risk factor for coagulation and cardiovascular disease, connexin 26, HPV genotyping, and drug response CYP450 2D6.

As with electronic data capture software products, there are quite a few genetic testing platforms available, without a dominant leader in either field. An alliance like this might be the needed advantage to win the crown.

Third Wave Technologies, (888) 898-2357, www.twt.com.

MDS has put their hearts into offering one-stop shopping for most every conceivable type of ECG safety test

MDS Pharma Services (Montreal, QB) offered a strong suite of cardiovascular safety tests for six years, long before FDA guidelines indicated that it should be a standard part of drug development.

To make FDA's recent mandate more manageable, MDS created a centralized ECG service that offers a wealth of arrays, from one convenient source. The list includes specialized tests such as hERG K+ ion channel assays and Patch-Clamps to the more standard pharmacokinetic/pharmacodynamic tests. Most every test from preclinical to postmarketing is available (12-lead digital ECG recorder pictured above).

Testing is interpreted automatically and supervised by cardiologists. ECG interval measurements can be monitored. And the data generated from the tests is available from any Web site.

MDS Pharma Services also has over 900 beds devoted exclusively to Phase I trials, the most in the industry. It is a division of MDS, Inc. (Toronto, ON), a life sciences company which also focuses on drug discovery, development, and health care. The enormous (11,000+ employees) company began as a diagnostics lab. MDS has 30 years experience in the laboratory area.

MDS Pharma Services, (402) 476-2811, www.mdsps.com.

Gain access to study data from any time zone, at any time of day or night, with Covance's StudyTracker

Covance's (Princeton, NJ) StudyTracker program was designed for people who don't work a nine-to-five but still want immediate service when they require data about their trial. StudyTracker recently passed the thousand-user mark, which makes it, technically speaking, a grand success.

To enter the StudyTracker Web site, users need to enter a constantly changing six-digit ID, matched up to a SecurID device, usually worn as a key ring or necklace. What's available for those who know the password is near-real-time data warehouse. Populating that warehouse is data and information for mammalian toxicology, bioanalytical, and metabolism data. Users can exchange files with Covance staff, review study schedules, create reports and then view them either on screen or as Comma Separated Values. StudyTracker launched in March 2001; Version 2 arrived in April 2003.

Covance says StudyTracker can save up to four hours a week since the information you need won't require playing a game of phone tag.

Covance, (609) 452-4440, www.covance.com

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