BioNTech Launches MammaTyper® Breast Cancer Diagnostic Test in Europe

MAINZ, Germany, June 11, 2015 /PRNewswire/ —

Easy-to-use molecular diagnostic test with potential to significantly improve the standard treatment of breast cancer patients

BioNTech’s first product to market

BioNTech AG, a fully integrated biotechnology company developing truly personalized cancer immunotherapies and its subsidiary BioNTech Diagnostics GmbH, today announced the launch of MammaTyper®, a CE-IVD marked molecular diagnostic test to stratify breast cancer patients by molecular subtyping of routine tumor tissue, for universal use in pathology laboratories. Based upon precise measurements of gene expression by RNA analysis, MammaTyper® has the potential to significantly improve the standard of diagnosis and ultimately treatment of breast cancer patients and underscores the Group’s commitment to its goal of making truly personalized medicine broadly available in oncology.

Expert medical European guidelines for breast cancer diagnosis and treatment recommend that all breast cancer be routinely subtyped using four well-established genetic markers. These analyses allow stratification of patients by the genetic subtype of the tumor, giving prognostic and predictive information so that optimal therapy can be chosen.

MammaTyper®, developed in collaboration with STRATIFYER, a  molecular diagnostics company, is a molecular in vitro diagnostic test, based on RT-qPCR technology that allows a quantitative, accurate and reproducible detection of the mRNA expression levels of these four well established biomarkers (ESR1, PGR, ERBB2 and MKI67) of breast cancer tumors as recommended by the St Gallen Expert Committee[1]. The test can be used on all female patients with newly diagnosed invasive breast cancer and is now available in Europe and all countries that recognize the CE-standard. MammaTyper® has the added advantage that the test can be used in any molecular pathology laboratory with same-day results.

Sean Marett COO, of BioNTech, said: “The launch of our first product, MammaTyper®, demonstrates BioNTechs true capabilities as a fully integrated and operational business. Launching MammaTyper®and other future diagnostics currently in development will help us to establish BioNTech in the oncology market, in preparation for launch of our immunotherapies for the treatment of cancer. The launch also underscores the Groups commitment to its goal of making truly personalized medicine broadly available in the field of oncology. Each cancer is not a single disease. Different genetic subtypes require different therapies making correct genetic subtyping critical to treatment success. Within the BioNTech Group, BioNTech Diagnostics has a mission to provide new and innovative diagnostic tests to extend lives of patients, improve their quality of life and support the use of appropriate therapy for each individual patient.

The MammaTyper® test can be used together with the recently introduced RNXtract® RNA Extraction Kit (IVD) which offers a reliable, robust and easy-to-use method to gain high quality amplifiable template RNA from formalin-fixed, paraffin embedded (FFPE) sample material. RNXtract® has been specifically designed for use with MammaTyper® and other tests from BioNTech Diagnostics’s development pipeline.

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DigiPath Labs Completes First Medical Cannabis Test

LAS VEGAS, June 11, 2015 /PRNewswire/ — DigiPath Labs of Las Vegas, the cannabis testing subsidiary of DigiPath, Inc. (OTCBB and OTCQB: DIGPD), successfully completed its first commercial test of cannabis material. In the short time it’s been open, the company has already proven that it has the equipment and knowledge needed to reliably test medical cannabis for safety and potency.

“We are open for business,” said Todd Denkin, president of DigiPath Labs. “It’s been a very long and arduous process, but we jumped through all the hoops and cleared all the obstacles, and now we’re testing cannabis products and generating revenue, an important milestone to our shareholders.”

As one of only two labs currently operating in Southern Nevada, DigiPath Labs is positioned at the forefront of what is anticipated to become a rapidly growing industry in the Silver State. According to ArcView, the legal cannabis market exploded from $1.5 billion in 2013 to $2.7 billion in 2014—a 74% increase in just one year.

Greenwave Advisors estimates that the market could reach $35 billion by 2020 if marijuana is fully legalized across the country, or $21 billion under the more likely scenario of 12 states legalizing recreational use and 37 states legalizing medical use.

States are increasingly requiring cannabis product testing to quantify cannabinoid and terpenoid levels, and to ensure the products do not contain potentially unsafe levels of contaminants, such as pesticides, mold, insects, heavy metals, and solvents. Of the 23 states that allow medical marijuana use, eight currently require testing, and five other states are now considering testing legislation.

“We don’t see any other industry experiencing this level of growth,” notes Denkin, “and we’re very excited about the future.”



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