Originally Published IVD Technology July/August 2002
Industry News
Notable
Roche Molecular
Diagnostics (Pleasanton, CA) recently received 510(k) clearance for its
Cobas Taqman analyzer. The analyzer expands on the capabilities of the company's
Cobas Amplicor analyzer and features improved polymerase chain reaction (PCR)
technology. The Taqman system uses fluorescent-labeled probe technology for
real-time PCR photodetection at the completion of each cycle. Along with increased
speed, real-time quantitation PCR reduces the threat of contamination, as the
entire test takes place in a sealed tube.
In addition, the
Taqman system can amplify over a seven-to eight-log dynamic range without dilution,
while the Amplicor has only a three- to four-log range with dilution for high
copy samples. The improved system can measure fluorescence at four excitation
and emission wavelengths.
"Providing our clinical laboratory customers with total PCR automation has been a major goal for us as we continue our technology development efforts," says Heiner Dreismann, PhD, head of Roche Molecular Diagnostics.
The U.S. District Court for the District of Nebraska has ruled that the 5C Cell control product from Beckman Coulter Inc. (Fullerton, CA) infringes four patents belonging to Streck Laboratories' (Omaha, NE) patents. Streck manufactures and sells hematology control products and in May 1991 filed a patent for a hematology control product for use with Coulter's STKS hematology instrument. In February 1992, Coulter, the predecessor to Beckman Coulter, filed the patent that the court ruled infringed upon Streck's technology.
In a counterclaim that was removed from the case in September 2001, Coulter claimed that Streck had infringed upon its patent.
The court cited uncontroverted evidence that "Coulter's 5C Cell control contains all the elements of at least one claim of each of the four patents (Streck) alleges have been literally infringed."
The IVD labeling working group of industry trade association AdvaMed (Washington, DC) is distributing a survey to clinical labs that includes questions about usage on IVD product labeling. The organization hopes to determine the amount of education needed for proper symbol interpretation using the survey results and by holding focus group discussions with U.S. clinical lab personnel.
The survey covers alternative methods of providing instructions for use, including Internet and CD-ROM labeling, and also covers current symbol usage on product labeling.
The group hopes to use the assessment to aid FDA in its symbol decision-making process and to help firms avoid receiving warning letters from FDA. However, until FDA makes a decision regarding product labeling, companies using symbols are at risk of being misbranded.
Quest Diagnostics
Inc. (Teterboro, NJ) plans to acquire Unilab Corp. (Tarzana, CA)
in a $1.1 billion transaction. Under the terms of the agreement, Quest will
acquire all of Unilab's operations, including 3 full-service labs, 39 rapid-response
labs, and 386 patient-service centers.
Kenneth Freeman, chairman and CEO of Quest Diagnostics, says the acquisition will strengthen the company's position in the California testing market. "This transaction will establish a leading position for Quest Diagnostics in the largest and one of the fastest-growing diagnostic testing markets in the United States," says Freeman.
Ciphergen Biosystems Inc. (Fremont, CA) recently announced that its ProteinChip system, featuring the company's surface-enhanced laser desorption ionization (SELDI) technology, has been used by researchers at Harvard University's Brigham and Women's hospital to identify a potential biomarker for early detection of ovarian cancer. The study researchers intended to identify common protein markers among multiple subtypes of ovarian tumor samples, according to Samuel Mok, director of the gynecologic oncology lab at the hospital. "We found that the alpha subunit of the haptoglobin protein was elevated in serum samples across patients with different subtypes of ovarian tumors, and less so across the healthy control samples," says Mok.
Using the ProteinChip system, an 11.7-kD protein peak was found to be elevated in a majority of the serum samples. According to Ciphergen, testing of 171 samples achieved 90% specificity and 71% selectivity—greater than any currently available blood test for ovarian cancer—when using this haptoglobin peak as the diagnostic criterion. The SELDI ProteinChip system allows researchers to collect reproducible protein expression data on hundreds of proteins at once for comparative analysis.
Copyright ©2002 IVD Technology
