High Throughput Gene Expression Analysis
Althea's current services include high throughput gene expression analysis using its eXpress Profiling technology, custom real-time qPCR assay development services, cGMP protein and plasmid DNA production services, and aseptic vial and syringe filling of Phase I, II, and III clinical products.
"It's a common trend where microarray-based global gene expression surveys yield small sets of key genes, typically fewer than 100," said Monforte. "What we're offering is a way to move these genes from microarrays into low-cost multiplex PCR assays, enabling larger throughput, quantitative studies of these genes."
Althea's Discovery Services are driven by the application of eXpress Profiling (XP PCR) for high throughput gene expression analysis.
XP PCR is a patented, highly multiplexed, quantitative RT-PCR strategy that incorporates the use of gene-specific and universal primers to lock gene ratios during the amplification process.
This method, which yields data on 2035 genes per reaction, enables researchers to extend their gene expression studies to a large number of samples, increasing the statistical power of gene expression information."The technology is highly complementary to microarray analysis and enables researchers to further exploit their microarray discoveries," said Monforte.
Althea provides access to eXpress Profiling for a variety of research applications performed under GLP and non-GLP conditions.
These applications start with basic services such as microarray data validation and extend to comprehensive research programs, like Signature Discovery Services, that involve microarray experiments, detailed data mining and analysis, and high throughput application with XP PCR.
XP PCR has been licensed to Beckman Coulter and is being commercialized as the GeXP line of equipment and reagents.
"Through our partnership with Beckman we are making the process, now only performed in our lab, broadly available to the scientific community," Monforte noted. "The system lends itself not only to research but for diagnostic purposes as well. The only customization is what genes you're looking at. It makes it cost-efficient."
A&G Pharmaceutical (Columbia, MD) is a theranostic company creating and developing monoclonal antibodies to disease-specific targets as a basis for novel therapeutic and diagnostic products addressing a broad range of diseases.
The company is currently advancing a near-term opportunity to develop and commercialize a line of diagnostic test kits that will improve early detection, diagnosis, and treatment of breast cancer based on a patented and proprietary biomarker discovered by A&G researchers.
A&G is developing the same marker protein as a novel breast cancer therapeutic, and the firm's customized antibody service generates revenue to fund the drug development effort by accelerating the generation of novel, functional antibody therapeutics for pharmaceutical and biotechnology companies as well as federal laboratories.
Co-founder and CEO Ginette Serrero, Ph.D., discovered this protein as a biomarker for breast cancer with therapeutic and diagnostic capabilities termed PC Cell-Derived Growth Factor (PCDGF|GP88, or GP88).
GP88 is an 88 kDa glycoprotein autocrine growth factor that is produced by cancer cells and, in turn, binds back to the same cancer cells, fueling the growth of the breast cancer. GP88 thus plays a major role in promoting human metastatic breast cancer cell survival, growth, and invasiveness. A&G is developing both therapeutic and diagnostic products with this new theranostic target.
"The one thing we are doing differently is that we are using biomarkers for therapeutic as well as diagnostic targets," Dr. Serrero said. "And the beauty of what we're doing is that our kits can be used for both diagnostic purposes and, as we grow, we'll be looking to use them to monitor therapy as well. Our ultimate goal is to have a good therapy in place."
"Basically, what we are dealing with is a biological target overexpressed in invasive ductal carcinoma that induces tamoxifen resistance in ER-positive breast cancer cell lines, both in in vitro and in vivo mouse xenografts," Dr. Serrero explained. "Tamoxifen-resistant cell lines had a 10-fold higher instance with this biomarker than tamoxifen-sensitive counterparts."
"The biological target, or biomarker, we've identified can be used both for diagnostic and therapeutic purposes," Dr. Serrero said. "And we've developed an application that can do both.