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Dx Focus: Meridian's Illumigene Group A, B Strep Tests; Cynvenio Biosystems' LiquidBiopsy Service


Meridian Bioscience said this week that the US Food and Drug Administration has re-categorized its Illumigene Group A Streptococcus and Group B Streptococcus tests as moderate complexity under the Clinical Laboratory Improvement Amendments.

Illumigene Group A Streptococcus is a qualitative molecular test to detect Group A Streptococcus pharyngitis. Acute pharyngitis is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted, with an estimated 15 million visits per year in the US. Clinical studies show that Illumigene Group A Streptococcus increased detection of positives by 53 percent over traditional culture in symptomatic patients.

Meantime, Illumigene Group B Streptococcus fully complies with the US Centers for Disease Control guidelines for the detection of GBS, and clinical studies have shown that broth enrichment, followed by testing with Illumigene Group B Streptococcus increased detection of true positives by 29 percent over traditional culture, thus allowing for appropriate treatment of the mother at time of delivery.

Meridian's Illumigene tests use the loop-mediated isothermal amplification and can be performed without expensive laboratory equipment.

"Due to its simplicity and superior accuracy, our Illumigene technology platform enables most clinical labs to perform sophisticated molecular diagnostics without the high costs of capital equipment and ongoing service charges," Meridian CEO Jack Kraeutler said in a statement.

Cynvenio Biosystems this week announced the commercial availability of its LiquidBiopsy lab service for the recovery and genomic analysis of circulating tumor cells directly from whole blood.

LiquidBiopsy is a highly sensitive platform and associated biochemistry that can reliably isolate CTCs from whole blood for genomic analysis, Cynvenio said.

In engineered benchmarks, the system delivered consistently high CTC recovery rates of greater than 90 percent directly from whole blood, with very low non-target capture of fewer than 80 cells/mL blood — at least two orders of magnitude higher purity than earlier technologies, the company said.

With these purity levels and the Cynvenio-designed automated platform that processes multiple 7.5-mL blood samples in under three hours, CTCs obtained by LiquidBiopsy can be directly sequenced without additional error-inducing sample manipulation such as whole-genome amplification, Cynvenio said.

The LiquidBiopsy lab service offers three core services involving CTC isolation from whole blood:

• CTC Sequencing: targeted resequencing with a 50-oncogene panel and more than 2,100 mutations surveyed, with a turnaround time of seven days.

• CTC PCR Analysis: analysis by PCR of 45 cancer genes, including EFGR, BRAF, and KRAS with a turnaround time of five days.

• CTC Recovery and Numeration: cytokeratin, DAPI, and CD45 staining with scanning report, with optional return of target cells for downstream analysis at customers’ lab and a turnaround of three days.

The CTC molecular analysis can be performed by Cynvenio or, optionally, the target CTCs can be stained and returned to the ordering customer with a scanning/enumeration report for further study and analysis.

Cynvenio’s automated CTC isolation platform and sequencing lab service have been available to customers such as pharmaceutical companies since earlier this year, the company said. The new LiquidBiopsy lab is expected to complete CLIA certification in early 2013.