NEW YORK – Array Genomics is in the midst of rolling out its microarray-based test for staging and grading bladder cancer based on urine samples. The molecular diagnostics company received a CE-IVD mark for the assay, called BCA-1, in June, and launched the test in October.
While Array Genomics has seen some initial demand for the test, which is currently paid for out of pocket, the company is keen to support more studies that will raise the profile of the firm and its product and perhaps see it adopted into European urology guidelines.
"Currently, there is no kind of reimbursement for these kinds of products," said Steven Jones, vice president of strategy and marketing at the company. "We are only selling it to those who can afford it. That's why we want to get into guidelines, so there is some form of reimbursement for the test."
Array Genomics Ltd was founded in Swindon, UK, in 2015 The firm commercializes technology developed at ArrayGenomics SA, a 16-year-old French technology company. The BCA-1 Test has been years in the making. The French firm initially developed its assay for use on bacterial artificial chromosome arrays but moved to an oligonucleotide array manufactured by Agilent Technologies about a decade ago. ArrayGenomics SA introduced the array for research use in 2012. Since 2016, Array Genomics Ltd had been working toward the CE-IVD mark in the UK, which it gained earlier this year.
The assay relies on 27 markers to diagnose bladder cancer, as well as to discriminate low-grade from high-grade tumors, and provides information on the stage of the cancer as well. The test is run on DNA samples extracted from urine and requires about 100 nanograms of DNA, according to the firm. The test retails for £299 ($393) on its website, and the company claims a 10-day turnaround time after review by an expert urologist.
Though the company's technology was developed in France, it decided to seek its CE-IVD mark through the UK Medicines and Healthcare Products Regulatory Agency. Jones, who is based in the UK, said this was due in part to the fact that the test is still offered to those who can afford to pay for it, and France restricts most direct-to-consumer testing. The BCA-1 Test is sold through the British company, which has contracted with ArrayGenomics SA in France to use the technology. According to Jones, Array Genomics Ltd. is neither owned nor affiliated with ArrayGenomics SA.
The company very much sees the UK and France as a staging ground for reaching the rest of Europe, as well as the world. It has already won over a number of academic collaborators, including Olivier Cussenot, a professor of urology at Tenon Hospital in Paris; Stephane Larré, a professor of urology at the University Hospital Center of Reims; and James Catto, a professor of urology at the University of Sheffield. The company's technology has also been discussed in four publications to date, three of which came out of Cussenot's group. Cussenot, Larré, and Catto did not respond to requests for comment.
"We have been continuing our research, especially in the UK and France," said Jones. "We have been fine-tuning the tool and making sure we can increase the sensitivity to a very high level, while creating more data for publication via larger studies," he said.
Array Genomics would like to keep this momentum going. Next year, the plan is to commence some new studies with British and French partners that could see the test eventually reviewed for inclusion in future guidelines. The company is positioning the molecular test as an adjunct to cytoscopy, where patients undergo an invasive procedure to collect a bladder tissue sample. By better determining which patients are at the highest risk for the disease, the company hopes its test will enable clinicians to rule out cytoscopy in certain cases.
"It offers an alternative to invasive procedures that cost money to health organizations as well as are painful to patients," said Jones.
At the moment, Array Genomics is reaching out to various funding mechanisms on the UK, such as Cancer Research UK and the UK National Institute for Health Research about supporting new studies. The company aims to obtain funding for these plans by May. The planned studies will focus on the cost savings of applying the test, as well as how it could be integrated into current practices in the UK. The company also intends to work with clinicians within the European Association of Urology to build a follow-on study in different locations to assess integration of the test in current health pathways.
Jones noted that successful outcomes in these studies could build the case for reimbursement in European countries, as each country will require evidence the test offers a cheaper alternative with a better or equivalent performance, and is clinically valid and has been reviewed by experts.
"With these items [achieved] it is much easier to go to health ministries and get reimbursement," he said. He said the company aims to win reimbursement for the test within France and the UK within the next five years and will pursue a similar strategy in other European countries thereafter.
The US is not off of Array Genomics' radar. Jones described the American market as the "holy grail" for the company, and that it would likely access the market first via a testing partner such as Laboratory Corporation of America. He also said the company is looking into routes for launching its test in China, elsewhere in Asia, and in the Middle East.
Array Genomics' technology is also applicable in other indications, the firm has claimed. The company believes the panel can be used to diagnose and stratify kidney cancer and prostate cancer patients as well. However, it had decided to focus on bladder cancer, as its kidney test requires a biopsy, and he described the market for prostate cancer molecular tests as "crowded."
"Our 27-marker IP also covers prostate and kidney as part of the urology core system, though," he noted. "It can be run in parallel to the bladder test."