By Frances Bishopp
Aprogenex Inc. and Centocor Inc. completed a product development and license agreement which covers certain worldwide rights to Aprogenex's DNA Probe in situ hybridization technology.
Aprogenex said it granted Centocor rights to develop and sell products to detect HIV using instrumentation platforms other than flow cytometry, a cell-sorting and cell-counting method.
Aprogenex developed ViraFlow, a product designed to permit detection of HIV within cells and to enable quantification of viral activity within infected cells. The ViraFlow assay uses DNA probes for HIV RNA to detect and quantitate HIV activity.
"We have taken our expertise in developing specific oligonucleotide probes and applied it to the detection of HIV intracellularly," David Leech, president and CEO of Aprogenex, told BioWorld Today.
It is a novel approach, he explained, compared to polymerase chain reaction (PCR) and branch DNA assays, which look at plasma as a unit. PCR is a diagnostic technology marketed by Roche Molecular Systems Inc., of Branchburg, N.J., a subsidiary of Roche Holding Ltd., of Basel, Switzerland. Branch DNA assay is marketed by Chiron Corp., of Emeryville, Calif.
"Neither one of these diagnostics looks at viral load within an intact cell," Leech said. "The ability we have with our technology is to be able to detect and monitor the progression of HIV virus intracellularly."
ViraFlow has not been approved by the FDA and is available as a research-only product, Leech said.
Centocor Will Market HIV Test
Aprogenex will receive an up-front licensing fee, milestone payments and royalties on commercial products used by Centocor. Centocor, of Malvern, Pa., will be responsible for development, regulatory approvals and marketing activities. Financial details of the agreement were not disclosed.
Aprogenex, of Houston, manufactures and markets rapid DNA probe-based test systems based on its RIGHTechnology, which is applicable to markets in genetics, oncology, virology and microbiology.
Aprogenex's RIGHTechnology (Rapid Intact Gene Hybridization Technology) is based on an advanced form of in situ hybridization — the use of DNA probes to hybridize, or bind to targets, within intact cells.
The two principal components of the technology are its "cocktail" and synthetic DNA probes. The "cocktail," or reagent solution, renders the cell and its nucleus permeable, allowing the probes to enter quickly and bind to target nucleic acid sequences in a one-step process.
The solution is applied to subject cells, which are then heated for a specified time. This process causes the targeted DNA strand in the heated cell to twist and untwist without completely separating, so the probe can rapidly enter and bind to the targeted nucleic acid.
The targeted cell is then cooled.
Aprogenex's "cocktail" and synthetic probes can be applied to multiple targets (DNA or RNA) in many types of host cells.
The company's first product, the AproProbe test, a research product that includes DNA probes to simultaneously identify fetal cells and analyze chromosomes within the cells, is currently available for sale in the U.S. and Europe for research purposes only.
Leech said the company's commercial strategy is to find partners who are developing cell separation systems. Aprogenex has an agreement to supply DNA genetic probes to Separations Inc., of Tucson, Ariz., and AmCell Corp., of Sunnyvale, Calif.
Aprogenex has plans to expand into medical therapeutics, Leech said, and is in discussions with a number of academic institutions and bankers with that focus.
Aprogenex, as of Dec. 31, 1996, had $1.2 million in cash and a net loss of $2.9 million.
Its stock (AMEX:APX) closed Friday at $9.625, up $0.125. *