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Product Development
Infectious Diseases HPV Assay Persistent infection with a high-risk human papillomavirus (HPV) type is associated with developing cervical cancer. HPV DNA can be detected in almost all cases of cervical cancer. HPV and cervical cancer disproportionally affect women in developing countries. Besides issues with sample transportation and lack of trained medical personnel, many such countries have cultural issues in the collection of cervical cell samples for the traditional Pap smear. Screening with molecular tests, however, require the same cervical cell samples. Xenomics has developed a safe, non-invasive method for detection of HPV DNA using the proprietary Tr-DNA technology. We successfully demonstrated the isolation and detection of HPV DNA harvested from adult urine. Tuberculosis Assay Tuberculosis (TB) infects approximately 2 billion people worldwide. With over 8 million new infections per year, about 2 million die from TB annually. The gold standard for detection of active TB infection in adults is a positive culture or acid fast bacillus stain (AFB) from sputum samples, both time-consuming procedures that require technician skill. The limitations of the conventional culture, smear, and chest radiography methods of diagnosis are at least partially addressed by the development of nucleic acids tests (NATs). The commercially available TB NATs rely on assaying of sputum samples, often difficult or impossible to obtain especially from pediatric patients. For these reasons, a safe and non-invasive method for testing for TB in patients is highly desirable. Xenomics has constructed a strategy to develop a safe, non-invasive method for detection of TB using the proprietary Tr-DNA technology. We successfully demonstrated the isolation and detection of TB DNA harvested from adult urine. We are currently developing the TB DNA assay using a real-time PCR format and demonstrating the medical efficacy of analytical sensitivity. The assay for detection of Mycobacterium tuberculosis (MTB), will seek a Premarket Approval (PMA) from the FDA
Prenatal Testing Gender Determination assay The discovery of cell-free DNA in the bloodstream (so-called circulating cell-free DNA, or ccfDNA) has led to intensive studies of its potential diagnostic applications in different areas, including prenatal diagnostics. The half-life of ccfDNA is about 15 minutes, and a portion of these circulating DNA fragments cross the kidney barrier and can be found in the urine as Tr-DNA. The existence of Tr-DNA was proven by detection of Y chromosome-specific DNA sequences in urine of women with male fetuses. We created a reliable test for prenatal early gender detection of a fetus, by applying two approaches: [1] a new technique for the purification of Tr-DNA and [2] we have developed an "ultrashort" target PCR technique for Tr-DNA analysis. We use a combination of these two approaches for gender detection of a fetus by PCR amplification of Y chromosome-specific SRY sequences from maternal urinary DNA.
Oncology AML assay Acute myeloid leukemia (AML) is an aggressive form of cancer that begins in cells that normally develop into blood cells. The bone marrow cells are unable to properly mature. Immature leukemia cells, called blasts, continue to reproduce and accumulate in the bone marrow, then usually quickly move into the blood, and sometimes spread to other organs. "Acute" refers to the fact that the leukemia develops quickly, and if not treated, will likely be fatal in a few months. Some types of acute leukemia respond well to treatment and many patients are cured especially when detected and treated early. Other types of acute leukemia have a less favorable outlook which makes it especially important that detection and diagnosis be made early and the type be determined quickly to permit initiation of the most effective therapy. Thus, diagnostics of AML must be rapid, and typing must be effective to define prognosis and to provide a patient with timely and effective treatment. Recently Drs. Cristina Mecucci and Brunangelo Falini, collaborators at the Institute of Hematology at the University of Perugia in Italy have discovered a new very important genetic marker for an aggressive type of AML. This new genetic marker indicates the presence of mutations in the gene called nucleophosmin, or NPM gene. This gene is involved in numerous normal cell processes that then go wrong as a consequence of the mutation. The presence or absence of the mutant NPM gene is important for diagnostic accuracy, prognosis and monitoring of the disease. Xenomics has obtained exclusive license for this new AML genetic marker, and has now developed a first generation test for the detection of the NPM gene mutations in bone marrow and blood cells. The Company is now preparing to move this new test forward into the clinical setting to soon make it available to patients and physicians. Our next goal is development of Tr-DNA-based test for AML, which could substitute a very invasive procedure of bone marrow biopsy.
Diagnostic assay steps 
Collection of urine samples is commonly performed for testing of patient metabolites, drug screening, and other medical tests. Collection and shipment for Xenomics assays will require little or no change from standard urine collection practices. Once a urine sample has arrived at a clinical lab, the trans-renal DNA (Tr-DNA) is extracted. Xenomics is developing standard methods to isolate the short nucleic acid segments that make up Tr-DNA. Amplification and detection of disease-related targets may be done by many alternative methods. Xenomics is developing detection using real-time PCR and gel analysis to fit the needs of most diagnostics labs. |
Xenomics
is developing molecular diagnostic assays for clinical use with regulatory approval.
Proof-of-principle experiments have been completed for each of our four major applications:
infectious disease testing; cancer detection and monitoring; organ transplant rejection;
and prenatal genetic testing.