ArrayGenomics recently began selling a comparative genomic hybridization array that it claims can be used to diagnose, grade, and stage bladder cancer based on DNA extracted from urine.
Charlie d'Estries, the US sales liaison for the French firm, said this week that the firm is now selling the assay kit to customers in North America for research use only. He said that the assay, called BCA-1, is already available in France and will become available in other EU countries "shortly." He did not elaborate.
BCA-1 is the first assay commercialized by ArrayGenomics, but the company has more in its pipeline, including assays for kidney, prostate, and lung cancers. D'Estries said that ArrayGenomics plans to introduce these assays over the next two years but he declined to provide further detail on them.
Founded in 2003 and based in Voisins-le-Bretonneux, south of Paris, ArrayGenomics originally developed its BCA-1 assay using bacterial artificial chromosome arrays but last year transferred the test to an oligonucleotide microarray platform to offer "increased sensitivity," said d'Estries.
The BCA-1 assay is available on Agilent Technologies' 8x60K array format, which provides eight 60,000-marker arrays per slide. The arrays are sold in a kit for customers to run in their own labs. D'Estries said that the company is looking into making the assay available on other array platforms and will soon finalize those plans.
The assay relies on 27 markers to diagnose bladder cancer, discriminate low-grade from high-grade tumors, and provide information on the stage of the cancer. The assay is run on DNA samples extracted from urine samples. According to the firm, the assay requires about 100 nanograms of DNA.
The assay has been validated by laboratories in Europe and is currently being validated in North America. D'Estries said that the firm has a customer on the West Coast — a "large urology reference laboratory" — that is carrying out the validation internally so that it can add the test to its menu. He declined to name the customer.
ArrayGenomics hired d'Estries last year. He said the firm is looking to expand its US presence this year by hiring sales and marketing and technical support teams. He added that the firm is "discussing different options" for "going after the US market."
Competing assays on the market include traditional methods for the detection and surveillance of bladder cancer, such as cystoscopy and urine cytology, as well as more recent tests, such as Abbott Molecular's UroVysion, which relies on fluorescent in situ hybridization to detect characteristic cytogenetic imbalances associated with the onset of bladder cancer.
Abbott's UroVysion and ArrayGenomics' BCA-1 assay both provide copy number evaluation of chromosomes 3, 7, and 17, as well as locus copy number evaluation of 9p21, but ArrayGenomics' test also provides copy number evaluation of the chromosome arms 5p, 8p, 8q, 11p, 17p, 17q, and 20p, the firm claims on its website.
The presence of at least one copy number aberration in the latter chromosome regions has been associated with an increased risk of tumor progression, according to the company. ArrayGenomics claims that information from BCA-1 can be incorporated into the clinical evaluation of presumptive bladder cancer patients to "provide a clinically relevant framework with which to consider treatment options."
Though BCA-1 provides this additional information, d'Estries said that ArrayGenomics does not view it as a replacement for UroVysion or any other test. "This provides additional information to the urologist and pathologist," he said.
ArrayGenomics is marketing its assay for research use and has no immediate plans to obtain clearance from US regulatory authorities to offer it as a diagnostic, though that could change.
"Right now, we are fine with the RUO designation," said d'Estries. "But as a company we are looking down the road at other markets, such as molecular diagnostics," he said.
ArrayGenomics has worked with a number of collaborators to develop its assay. These include Stéphane Larré, a lecturer and urological consultant at the University of Oxford; and Olivier Cussenot, a urologist at Hôpital Tenon in Paris. Larré and Cussenot were coauthors on a European Urology paper published last year that discussed ArrayGenomics' BCA-1 assay.
According to the paper, the researchers used a 341-BAC CGH array designed to include loci affected in bladder cancer. The chip was first used on 32 frozen biopsies to design staging and grading prediction models based on Bayesian network analysis. The models were then validated on external data obtained from 98 tumor samples using a 2,464-BAC CGH array. The performance of the test was finally assessed on 44 urine pellets, including 22 patients who had cancer and 22 controls. Performance was assessed by measuring sensitivity and specificity to diagnose cancer stage and grade from urine pellets.
In urine samples, BCA-1 test sensitivity was 95 percent, specificity was 86 percent, and accuracy was 91 percent, according to the authors. The staging model identified stage 1 to 4 tumors in the urine with a sensitivity of 90 percent, a specificity of 83 percent, and an accuracy of 87 percent. And the grading models detected high-grade disease with a sensitivity, specificity, and accuracy of 86 percent, 88 percent, and 87 percent, respectively.
Still, the authors noted that the test failed to provide results for eight samples, or 9 percent of those surveyed. Moreover, it required "high quantities and quality of DNA," and the authors called for external validation in "larger, prospective, and better-designed studies" to confirm performance.
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