Colorectal Cancer (CRC) is the third most common cancer worldwide1. Metastatic disease accounts for 40-50% of newly diagnosed patients and is associated with high morbidity1,2. Despite recent therapeutic advances, the prognosis for metastatic CRC (mCRC) remains poor. Early diagnosis and assignment of the most appropriate therapy pathway is therefore crucial. The KRAS/BRAF/PIK3CA Array from Randox allows the clinician to select appropriate patients for anti-EGFR therapy, maximising drug efficacy and minimising adverse side effects to the patient.

Crumlin, Antrim -- (SBWIRE) -- 12/13/2011 -- Monoclonal antibodies (MoAbs) targeting the epidermal growth receptor (EGFR) have proven effective in combination with chemotherapy or as single agents for treatment of mCRC 3,4. However, only a subset of patients with mCRC clinically benefit from EGFR-targeted moAbs.

Mutations in the KRAS gene are known to disrupt the EGFR pathway, rendering the anti-EGFR therapy ineffective. Presence of KRAS mutations accounts for approximately 35-45% of non-responsive patients5. Oncogenic mutations in genes encoding key downstream effectors within the EGFR signalling pathways may also be responsible for resistance to EGFR-targeted moAbs5. Mutations within the BRAF6 and PIK3CA7 genes have now been reported to affect patient response to EGFR-targeted moAbs.

The KRAS/BRAF/PIK3CA Array is designed for the rapid qualitative detection of point mutations within the genes KRAS, BRAF and PIK3CA from tissue DNA. The array offers a streamlined workflow, with the protocol and reagents specially optimised for the molecular laboratory and is compatible for use with a range of genomic DNA input and type including; cell lines, FFPE tissue and fresh/frozen tissue. A single DNA sample is required for testing, with results obtained in three hours. The technique of a single reaction multiplex coupled to a biochip provides greater mutation coverage of the three most important genes (KRAS, BRAF and PIK3CA) implicated in metastatic colorectal cancer therapy response. With three internal controls on each individual biochip, results are reliable.

The KRAS/BRAF/PIK3CA Array from Randox offers a rapid, reliable and simple method of selecting patients who are more likely to respond to anti-EGFR therapy, thereby allowing correct treatment to begin early, avoiding extra costs and adverse side effects associated with administrating ineffective treatment.

About Randox
Headquartered in the United Kingdom, Randox Laboratories Ltd. is a market leader within the in vitro diagnostics industry, manufacturing high quality diagnostic products for laboratories worldwide. Our extensive product portfolio offers complete solutions within the fields of clinical chemistry, cardiology, forensic toxicology, veterinary, drug residues, life sciences, oncology, molecular diagnostics and internal and external quality control. Our goal is to 'revolutionise healthcare through continuously improving diagnostic solutions.' We continue to achieve this year after year due to our commitment and significant re-investment in Research and Development. Our innovative approach to diagnostics allows us to develop revolutionary products, specifically designed to provide more efficient, higher quality and reliable results, ensuring patients receive the right diagnosis at the right time.

For more information contact us at marketing@randox.com

References:
1. Ferlay, J., Autier, P, Boniol, M., et al. (2007) Estimates of the cancer incidence and mortality in Eurpe in 2006. Ann Onol 18, 581-592.
2. Centers for Disease Control and Prevention: United States Cancer Statistics: US Cancer Statistics Working Group. http://www.cdc.gov/uscs.
3. Saltz, L.B., Meropol, N.J., Loehrer, P.J. Sr, et al. (2004) Phase II trial of cetuximab in patients with refractory colorectal cancer that expressed the epidermal growth factor receptor. Journal of Clinical Oncology 22, 1201-1208.
4. Cunningham, D., Humblet, Y., Siena, S., et al. (2008) Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. New England Journal of Medicine 358, 1160-1174.
5. Bardelli, A. & Sienna, S. (2010) Molecular Mechanisms of resistance to cetuximab and panitumumab in colorectal cancer. Journal of Clinical Oncology 28(7) 1254-1261.
6. Di Nicolantonio, F., Martini, M., Molinari, Sartore-Bianchi, A., Arena, S., et al. (2008) Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer. Journal of Clinical Oncology 26(35), 5705-5712.
7. Sartore-Bianchi, A., Martini, M., Molinari, F. et al. (2009) PIK3CA mutations in colorectal cancer are associated with clinical resistance to EGFR-targeted monoclonal antibodies. Cancer Research 69, 1851-1857.

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Crumlin, Antrim -- (SBWIRE) --11/21/2011 -- Vitamin B12 is found in many immunoassay controls. However, it is normally present at high, clinically insignificant levels, unsuitable when assessing assay sensitivity and performance at the clinical decision level. The Randox Acusera range of immunoassay controls provides clinically relevant levels capable of accurately assessing the sensitivity of vitamin B12 assays.

Vitamin B12, also known as Cobalamin, is an essential vitamin required for the formation of red blood cells. It is also responsible for maintaining the normal function of the brain and nervous system. A deficiency in Vitamin B12 can lead to the development of large immature red blood cells and subsequently, megaloblastic anaemia. A relationship also exists between pernicious anaemia and Vitamin B12 deficiency.

Individuals deficient in Vitamin B12 may also suffer from neurological and psychiatric abnormalities such as paraesthesias, depression and dementia. In normal individuals, Vitamin B12 levels may be anywhere between 200 – 900 pg/ml with values under 200pg/ml indicating deficiency; signs of neurological deficiency or anaemia are usually evident in patients with levels below 150pg/ml.

The Randox Acusera Level 1 Immunoassay Premium, Immunoassay Premium Plus, and Liquid Immunoassay controls are among the only controls on the market to contain sufficiently low enough levels of Vitamin B12 (approx 150pg/ml), enabling the assessment of assay performance at the clinical decision level, removing the need to purchase a separate Anaemia control. If you cannot test the sensitivity and performance of your method at clinically significant levels, how can you be sure your patient results are correct? Randox Acusera Immunoassay controls are supplied in three levels (which can be purchased either separately or in a tri-level pack), allowing assay performance to be assessed throughout the patient reportable range.

In addition to low Vitamin B12 levels, the Randox Immunoassay Premium and Premium Plus controls also contain ultra low levels of Ferritin and TSH as well as a wide range of other immunoassay parameters allowing consolidation of fertility hormones, thyroid hormones, kidney function tests, therapeutic drugs and other vitamins. In addition to this the Immunoassay Premium Plus control also contains many of the routinely run tumour markers including AFP, CA15-3, CA19-9, CA-125, CEA, PSA and Free-PSA.

All Randox immunoassay controls are true third party controls in that they are not designed for use with any particular reagent or instrument manufacturer. They are highly stable and 100% human in origin, meaning they will not be affected by changes to reagent batch.

For more information please visit http://www.randox.com or email marketing@randox.com.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm