NEW YORK (GenomeWeb News) – In a genomics market where new approaches are supposed to bury older ones, fluorescence in situ hybridization is proving to be an exception. Within the past few weeks Agilent Technologies and SciGene have both launched new products for a FISH market that they characterize as growing.
"If you talk to routine clinical customers, FISH is anything but declining, and in our estimates we think that FISH is posting double-digit growth year over year," according to Jimmy Jin, global product manager for Agilent's SureFISH offering. "Almost all of our customers maintain their volumes or their volumes are growing," he told BioArray News. "In terms of screening, arrays and next-generation sequencing are more effective, but in terms of diagnosis and confirmation, FISH is still the gold standard because it's simple and well reimbursed."
Agilent launched SureFISH two years ago, offering oligonucleotide FISH probes to compete against the bacterial artificial chromosome probe products that dominate the market. Last week, the firm said it would now manufacture custom oligo FISH probes designed using its SureDesign online application, which its customers also use to design and order their own arrays.
Jin said that the availability of custom oligo FISH probes should be attractive to the Santa Clara, Calif.-based company's array customers, many of whom use FISH to confirm array findings.
"I think there are very good synergies between our array offering and custom FISH," said Jin. "We have run pilot programs on custom FISH and a lot of the participants were actually our current array customers, so they are the first ones to know about it, use it, like it, and love it," he said. "It's unclear how many array customers will use custom FISH, but we see very good signs so far."
Along with interest from array customers, another factor driving growth in the FISH market is the Affordable Care Act. Jin noted that reimbursement for FISH has remained steady over the past year, and combined with the larger numbers of patients with access to clinical testing enrolled thanks to the Affordable Care Act, FISH volumes have continued to increase.
"Overall, what we have seen in routine clinical labs is that FISH is a hit in terms of reimbursement, and labs that do a lot of FISH tend to do very, very well," said Jin.
Because of that opportunity, Agilent plans to invest more in SureFISH. "We are betting big, it's here to stay, it's a very solid clinical product with great potential," said Jin. He said that Agilent has continued to develop its product line since it first launched two years ago, and while he would not comment on future FISH products, he maintained that Agilent has a "very strong pipeline."
'FISH isn't going away'
Jin acknowledged that Agilent isn't the only firm to sense an opportunity in the FISH market. Oxford Gene Technology, he noted, entered the market earlier this year with its acquisition of CytoCell. And SciGene, a Sunnyvale, Calif.-based company, has introduced a suite of new products for the market. The most recent is its CytoBrite Slide Oven, a 60-slide convection incubator for performing extended or overnight FISH assays. SciGene CEO Jim Stanchfield said that the FISH market has continued to grow, even as microarrays and sequencing garner the majority of interest in the industry.
"Every time a new technology comes along, people say that FISH is dead," Stanchfield told BioArray News. "Microarrays? FISH is dead. NGS? FISH is dead. But cytogenetics labs are drowning in samples and badly need automation. With the Affordable Care Act, labs are seeing 20 percent increases in volumes," he said. "So FISH isn't going away. It's expanding."
Founded in 2003, SciGene started out serving the array market with products such as its Little Dipper Microarray Processor and Mai Tai Hybridization Oven. But through its connections in the array field, the company became aware of the shortcomings of FISH, a technique that had been first pioneered in the early 1980s. "Most of our customers were using our products in cytogenetics, and they wanted us to look at FISH, so we started studying that workflow," Stanchfield said.
Based on that interest, the company over the past few years has introduced a suite of products for the FISH market. These include CytoBond Removable Coverslip Sealant, a polymer that SciGene says is superior to the rubber cement typically used for sealing slide coverslips; Cytozyme Stabilized Pepsin, a liquid formulation of purified pepsin for readying tissue samples for hybridization; Sodium Thiocyanate Pretreatment Reagent, another liquid formulation for pre-treating tissue samples; the CytoBrite Slide Incubation System; and a Little Dipper Processor for FISH and FISH wash buffers.
"We've done quite well," said Stanchfield of SciGene's FISH products. "Most of the leading cyto labs have a Little Dipper for FISH slide washing and hybridization," he noted, "and most of the big CMA labs use FISH for hybridization, so they go hand in hand."
And like Agilent's Jin, Stanchfield was positive about the prospects for the market.
"It's growing and we are just seeing the tip of the iceberg," said Stanchfield. "There are a lot of people moving into the healthcare system who now have access to these tests."
SciGene for its part will continue to develop new products to serve the FISH market. "We are always uncovering opportunities," Stanchfield said. "The closer we get to the bench, the more we get ideas for new products."