The biggest obstacle to getting his company’s microarrays into the clinical diagnostic realm is getting people to believe, said Gordon Janko, chief executive officer of Biocept.
“The array market itself has not really, in regards to clinical diagnostic[s], attained the precision and accuracy that is needed,” Janko told BioArray News. In this market, “you have to have sensitivity and specificity of in [the realm of] 99.5 percent.”
Biocept, a Carlsbad, Calif.-based company founded in 1997, claims its chromosomal disorder arrays, based on a substrate of modified polyethylene glycol polymer gel, have achieved 100 percent specificity and sensitivity in tests. And, despite the trouble that a major player – Roche — and others have had in the regulatory arena, the 17-employee outfit says it is “talking” with the FDA to try to get the product into clinical testing.
“[W]hen we go in and talk to people about what we’re producing and how our product works, they kind of look at us in disbelief,” Janko said.
But Janko is an experienced evangelist in the realm of novel medical devices. Between 1977 and 2001, he launched and marketed cardiovascular devices such as pacemakers, heart valves, and in 2000, the cutting balloon — a device that was so successful that the company Janko worked for, Interventional Technologies, got snapped up by Boston Scientific within a year of the product’s launch.
He came to the company when Interventional Technologies’ CEO, Bob Reese, became an investor in Biocept.
Janko recalled the moment: “Bob said ‘Gordon, I think this is a very good opportunity, ‘ . . . ‘look at it.’
So nearly a year ago, Janko talked to Soonkap Han, the biochemist behind Biocept’s technology. At the time, Han and his R&D team had begun work on a chromosomal disorders array, after a 2001 launch of their spotted hydrogel array for proteomics applications fell flat. [seeBAN 11/20/2001]
“When I spoke to Soonkap, I realized that were not really even a microarray. We were something that was the next generation,” said Janko, who signed on as CEO of the company in April.
The company’s original proteomics application failed to catch fire, which Janko attributed to the market for such products being “three to five years away.” So when he took the job, he focused the company on marketing clinical diagnostic applications such as the chromosomal disorders array.
The chromosomal disorders array includes chromosome-specific probes for all of the major aneuploid disorders and three microdeletion disorders — DiGeorge, Cri-du-Chat and Williams-Beuren, according to Han. The initial generation of the array will test purified PCR products from amniotic fluid or chorionic villus, and the subsequent generation, “which we think is the real home run with this product,” said Janko, will be able to test fetal cells isolated from the mother’s blood.
This next-level technology involves “efficient cell separation techniques,” said Herb Radisch, the company’s vice president of operations, as well as a means for making the array sensitive enough to detect as few as 40 fetal cells.
In the current chromosomal array, the probes are covalently attached to the polyisocyanate-modified polyethylene glycol polymer droplets, which have been spotted onto a Corning aminosilane-coated glass slide. Purified PCR product labeled with Cy3 dye is hybridized to the probes, then the signal is read and analyzed using the company’s algorithm to elicit diagnostic information, Han said.
The company’s results of 100 percent specificity and sensitivity come from tests against 24 normal samples and 48 abnormal samples. More rigorous testing will have to be done to see if the company’s claims stand up.
Additionally, the company will need to beef up its sales and science staff as well as its manufacturing capabilities if it wants to make its array into a viable product. Janko is raising outside financing, after initial funding raised primarily through friends and family of the founders, to do so. “We’re in a fundraising round right now to raise the funds to move into a large building to be able to manufacture 12,000 arrays per month,” he said.
The company uses a robot adapted from the semiconductor industry to spot down the polymers.
The chromosomal disorders array is the first of many products that the company envisions for the coming months and years. “We’re talking with a number of individuals about cancer diagnostics, heart diagnostics,” Janko said. But the next product in line is likely to be one more similar to the chromosomal disorders array — a diagnostic chip that tests for short-tandem-repeat-based genetic disorders such as Fragile X syndrome, Radisch said.
This strategy of transforming an array company stuck in R&D into an array-based clinical diagnostics shop sounds like that of a San Diego startup from the ‘90s: Nanogen.
Han, however, said there is a difference between the two companies: “The Nanogen system is very large, capital intensive,” he said. Biocept’s chips, by contrast, are compatible with standard readers and scanners.
Biocept will to follow Nanogen in one area. Just as Nanogen has sent its systems out to labs and research institutions along with applications specialists so the labs can become testing and development centers for its products, Biocept hopes to set up “labs of excellence,” Janko said. “Having a precise accurate array that can help with the diagnosis, early diagnosis, for cancer, heart disease, chromosomal disorders, and others, and giving a therapeutic solution, is the future.”