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General

nacgenX™ Diagnostics was founded in 2002 to address a growing need for non-invasive saliva based technology for rapid testing, sample collection, and molecular diagnostics [DNA, RNA and proteins] in the Life Sciences area. The Company is dedicated to meeting the need for more effective screening tools, which may be applied to the early detection of diseases and medical disorders, utilizing non-invasive test specimens, particularly oral fluids (saliva).

The Company’s range of collection and [future] diagnostic tools are covered by a portfolio of issued US, EU and International patents

Recognizing that early diagnosis is the key to disease prevention on a global basis, the Company directs its research efforts towards the development of oral based rapid, point-of-care, laboratory-based and molecular products, which fit into a Corporate objective of improving the quality of healthcare for our global customers.

Oral Fluid Products

nacgenX™ Diagnostics has developed a unique proprietary range of oral fluid products which includes the *VerOFy® oral fluid rapid test platform, the *Versi•SAL® split sample saliva / oral fluid collection device, the DNA•SAL™ Salivary DNA collection device, Super•SAL™, a device for universal saliva collection and RNAPro•SAL™, a novel device for RNA and or protein collection for genomic applications or proteomics and LIAM™ [Light Image Analysis Module], a reading device for lateral flow test assessment and quantification. Additional devices are under development.

The Company is also the exclusive North American distributor for a novel genomic product line from ViennaLab Diagnostics (Vienna, Austria), which is based upon pharmacogenomics and genetic predisposition. Products include rapid strip based assays for KRAS mutations, BRAF, Fc Gamma Receptors, Congenital Adrenal Hyperplasia [CAH], hemochromatosis, Alzheimer’s disease, cardiovascular disease (CVD), Familial Mediterranean Fever (FMF), Gaucher’s disease, sugar (glucose / fructose) intolerance, CYP2D6, HLA-B27, cystic fibrosis and others.

Pharmacogenomic Tests

Newer pharmacogenomic tests include novel immunoassays for identification of genotypes associated with response to Coumadin anti-coagulants including Warfarin, treatment response to HIV HAART and 5-fluorouracil chemotherapy treatment response.

Recently the Company announced a partnership to distribute products from Operon S.A. ( Zaragoza, Spain). Products in this range include strip format genomic tests for celiac disease and AZF micro-deletions in chromosome Y for male fertility.

Partnering / Collaboration

nacgenX™ Diagnostics is constantly searching for partners with innovative technologies that are synergistic with, or add value to, our technologies or tools under development by the Company. We welcome collaboration and partnerships from companies that see a role for salivary diagnostics in the future.

With this particular emphasis in mind, nacgenX™ Diagnostics is always open to discussing new business opportunities with potential collaborative partners, which fit into our Corporate strategy.

VerOFy®, DNA•SAL™, Versi•SAL®, 4saliva®, Super•SAL™, RNAPro•SAL™

and nacgenX™ Diagnostics are trademarks of nacgenX™ Diagnostics. These devices are the subject of a series of US and international patent submissions and issued patents.

Molecular Diagnostics

Molecular diagnostics is the driving force behind unraveling our biological makeup at the genetic level. The DNA code is unlocked, often revealing the fundamental differences between individuals who may be predisposed to development of diseases or more suitable for treatment options that may prove detrimental or ineffective in others.

Function of Molecular Diagnostics – Analyzes genetic content for disease information and can examine specific DNA regions to identify genetic mutations/genetic materials that may result from bacterium, viruses or cancer. New technologies also look at RNA through micro RNAs and mRNAs

Significance of Molecular Diagnostics – Identifies DNA sequences that may consist of inherited or random mutations that are indicative of inherent disease.

Benefits of Molecular Diagnostics – A person who is predisposed to a particular disease can make certain lifestyle changes to avoid and monitor development of the disease. Physicians can leverage a patient’s genetic information to select the optimal treatment strategy. Note: While a person may be found to have a certain genetic predisposition, it does not mean he or she will actually develop the disease.

The Company’s RNAPro•SAL™ and DNA•SAL™ salivary collection tools may be conveniently and cost effectively used to isolate genetic and non genetic material [RNA and proteins in the case of RNAPro•SAL™ and DNA in the case of DNA•SAL™], for use in downstream technologies, such as PCR, genotyping, microarrays, exome sequencing and others, when used in conjunction with suitably validated methodologies.

Point of Care Testing

Point of care testing is extremely effective when health care decisions must be made and appropriate actions must be taken in real time. Point-of-care testing provides immediate results when the patient is still at the clinic or other remote testing site. The resulting outcome is usually a more rapid diagnosis of disease leading to earlier enrollment into treatment regimens. Point-of-care testing is usually cost effective and can be performed by individuals with minimal training.

The Company’s VerOFy® point-of-care testing device is an enabling technology that may be used as the platform for the development of a series of qualitative and quantitative rapid saliva based diagnostic tests using lateral flow immunochromatography, latex agglutination, magnetic beads and others. Currently the Company is interested in developing specific applications in the areas of stress, dehydration, drugs of abuse, infectious diseases (including HIV and tuberculosis), steroid hormones, oncology, Alzheimer’s disease and Parkinson’s disease.

Laboratory Testing

Mainstream testing under laboratory conditions is still by far the largest segment within the industry. Blood, urine, tissue, serum, hair, saliva and other bodily fluids and samples are routinely tested for a multitude of conditions, diseases, drugs, biomarkers and other entities using multiple methodologies including ELISA, Fluorescence Polarization Immunoassay [FPIA], homogeneous immunoassays, mass spectrometry and many others.

nacgenX™ Diagnostics provides proprietary tools to aid laboratory scientists including its Versi•SAL® device for standardized whole saliva collection, UltraSal-2™ for large volume oral specimen collection and Super•SAL™ saliva collection device for universal saliva collection purposes.

The Company’s range of collection and [future] diagnostic tools are covered by a portfolio of issued US, EU and International patents.

With early diagnosis being the key to disease prevention efforts on a global basis, nacgenX™ Diagnostics directs its research efforts to the development of rapid, point-of-care, laboratory based and molecular diagnostic products, which fit into a Corporate objective of improving the quality of healthcare for our global customers.

With defined emphasis on saliva diagnostics, salivary tools and oral-based applications, nacgenX™ Diagnostics is always open to discussing new business opportunities including licensing, distribution and partnering with potential collaborative partners. For further information on such opportunities click here.

nacgenX™ Diagnostics is a global company targeting both domestic and international markets for its innovative saliva diagnostic portfolio.