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Dx Focus: Altona Dx's Filovirus Typing Assay; Clinical Genomics' Blood-based Bowel Cancer Dx


Germany's Altona Diagnostics said this week that it has launched the RealStar Filovirus Type RT-PCR kit, a real-time PCR assay for identification and differentiation of the five Ebolavirus species and Marburgvirus.

Together with its existing RealStar Fliovirus Screen RT-PCR kit, which is currently being used by the European Mobile Laboratory in the epidemic epicenter in West Africa, Altona now offers a comprehensive assay portfolio to detect and characterize filovirus RNA from human sample material, the company said.

The RealStar Filovirus Screen kit detects all five Ebolavirus species and Marburgvirus without differentiation, and is meant for first-line analysis, Altona said. Meantime, the Filovirus Type kit is intended as a second-line assay to confirm positive results and distinguish between the various viruses.

"In the current situation during this epidemic outbreak, it's more relevant that we were able to come up with a ready-to-use first-line test kit for filoviruses," Markus Hess, chief scientific officer of Altona, said in a statement. "The characterization of a positive sample by using the RealStar Filovirus Type RT-PCR kit … is more of epidemiological and scientific importance."

All RealStar PCR Kits consist of master reagents containing enzyme, buffer, primer, and probes as well as an internal control, a positive control or quantification standards, and PCR-grade water.
The kits are validated on most common real-time PCR instruments and with a number of extraction systems including the Altona's ExtraStar chemistry.

The kits are available as research-use reagents only, Altona said. A CE IVD marked version of the RealStar Screen kit will be available in September.

Australian firm Clinical Genomics said recently that it has launched a regional trial of ColoVantage, the country's first commercially available blood test for bowel cancer.

The regional trial is being initiated in the Blue Mountains community, approximately two hours from Sydney, where Clinical Genomics is headquartered.

ColoVantage Plasma is a blood test developed by Clinical Genomics in partnership with Australia's Commonwealth Scientific and Industrial Research Organisation, CSIRO, and clinically validated in collaboration with Flinders Centre for Innovation in Cancer.

The test uses multiplexed qPCR to detect and measure hypermethylation in two genes, BCAT1 and IKZF1, from patient blood samples. Hypermethylation of these genes has been previously demonstrated in colorectal adenoma and cancer tissues. Early clinical studies have shown the test can detect 65 percent of bowel cancer cases, with the detection rate increasing to 73 percent for more advanced cancers.

The test is designed for patients who cannot or will not carry out recommended screening with fecal immunochemical testing, which Clinical Genomics has also been offering since 2000 under the brand name ColoVantage Home/Insure FIT.

"The Blue Mountains has been chosen because it has a supportive local health insurer, accessible pathology services, and a strong network of local primary healthcare providers," Clinical Genomics CEO Larry LaPointe said in a statement. "The message for local residents is that the stool test is the best place to start for people aged 50 and or over who are due for screening. Then the blood test is for those people who can't or won't screen with a fecal test."