Hoping to grab a piece of the prenatal-testing market, Biocept, a closely held in vitro diagnostic upstart, is determined to get its first microarray-based diagnostic approved in the United States by the end of the year.
If successful, the company will not only enter a market that can run as high as $240 million a year, but may nab a greater share of that market than traditional diagnostics because its tests will eventually be less invasive.
Biocept’s microarray technology sounds deceptively simple: Its glass-slide-based, low-density arrays carry droplets of hydrogel that contain covalently attached probes. These probes capture DNA samples from patients, which are fluorescently labeled and amplified by PCR, and then read by a scanner.
Having initially developed the array for research purposes and for proof of principle, Biocept researchers began working on a chromosomal disorders array. The company now hopes to develop and begin selling to the prenatal-testing market two products based on this array.
Both products will be arrays to test for about a dozen chromosomal disorders, including the major aneuploid disorders, like Down syndrome, and three deletion disorders: DiGeorge, Cri-du-Chat, and Williams-Beuren. The first test will analyze amniotic fluid or chorionic villus samples during the second trimester, Janko said.
Compared to currently available tests, which use FISH technology or traditional karyotyping — which can take several weeks to produce results — Biocept’s test will provide results within a day, Janko said. In addition, the procedure covers a dozen tests simultaneously, whereas conventional tests have to be performed individually.
Janko estimates the test will cost between $500 and $800 per chip in the United States, and will be marketed to clinical laboratories. He said the test will be reimbursible by payors much like FISH tests are today. In fact, Janko said he hopes his array will eventually replace FISH testing. He added that it costs more today to perform each of the tests on the array individually.
According to Janko, between 250,000 and 300,000 amniocentesis or chorionic villus-sampling tests are performed in the United States every year. Though the American College of Obstetricians and Gynecologists recommends that all pregnant women older than 35 years should be tested for prenatal disorders, “not all of them are,” Janko said.
One reason that more women do not undergo testing for prenatal disorders is because tests that analyze amniotic fluid or chorionic villus samples are invasive. To that end, he said, Biocept is working on a second application of its array that would test fetal cells from maternal blood or cervical swabs. However, this test, which could be performed in hospital settings during the first trimester, requires a technology to separate out the fetal cells. Biocept is still working on this technology, said Janko.
Road to Regulatory Approval
Biocept has not yet determined under what terms it will submit the first test for regulatory approval in the United States, according to Herb Radisch, vice president of operations. Biocept is aiming to file with the US Food and Drug Administration for an investigational device exemption for clinical testing by the end of March, he said.
Clinical testing would probably take six to nine months, said Janko. So far, the company has tested the arrays against 24 normal and 48 abnormal samples and has found close to 100 percent specificity and sensitivity.
Biocept also plans to add other chromosomal disorders to its chip over the course of 2004. Once the first test is approved, the company hopes to expand into other disease areas, such as coronary artery disease, Lyme disease, or cancer.
“The biggest problem as a small company is [that] you have got to focus in on one [product] and get it to market before you can expand and look at other things,” said Janko. “You wish you had the pockets of a larger company to look at more things, but you just can’t.”
Currently, the company is trying to raise at least $10 million in venture capital and from “people who have invested in the past,” said Janko. Biocept started the funding round in early December 2003 and has almost 60 percent committed, mostly from past investors, he said.
The company would use the money to finance the clinical trial for the first test, build up a manufacturing capacity of up to 12,000 chip units per month, develop the isolation method for fetal cells, and release the product. For this test, Biocept may look for a marketing and distribution partner but plans to market the second test on its own, Janko said.