Easy and accurate early diagnosis of breast cancer is now possible with only 1 cc of blood

A Multibiomarker-based Breast Cancer Early Diagnosis Technology “MASTOCHECK” by Bertis Acquired New Excellent Technology (NET) Certification

- MASTOCHECK has acquired NET certification as a blood test method of diagnosis

that compensates for the limits of existing breast cancer screening

and as an innovative medical technology that can enter the global market and obtain meaningful results 
- Various benefits and forms of support are expected following the acquisition of NET certification
 

<(From left) Seung-man Han, CEO of Bertis, taking a commemorative photograph with Deok-cheol Gwon, CEO of the Korea Health Industry Development Institute,

at the “2019 2nd New Excellent Technology (NET) Certification Awards Ceremony”>

Bertis (CEO: Seung-man Han), a proteomics-based early diagnostic technology development company, acquired New Excellent Technology (NET) certification for “MASTOCHECK,” a multibiomarker-based breast cancer early diagnostic technology, at the “2019 2nd New Excellent Technology (NET) Certification Awards Ceremony” held by the Ministry of Health and Welfare and hosted by the Korea Health Industry Development Institute on the 27th of last month.

MASTOCHECK is a blood test method for the public that allows for easy screening of early-stage breast cancer. Three types of protein biomarkers in the blood closely related to breast cancer are measured quantitatively, and the values obtained are going through a unique, patented algorithm for early diagnosis of the disease.1 Stage 0, 1, and 2 breast cancer can be diagnosed with only 1 cc of blood, and even stage 1 breast cancer, which is difficult to identify with other screening methods, can be diagnosed with the high accuracy rate of 92% (based on a domestic patent).

MASTOCHECK acquired NET certification in the medical science field under the descriptive name “a breast cancer screening technology using the algorithmic calculation for levels of three types of breast cancer-specific plasma proteins.” In terms of the impact of this technological development, MASTOCHECK can aid diagnosis if an image is difficult to understand or decipher in early-stage breast cancer. It is also an easy and painless method useful for subjects who wish to avoid undergoing X-rays or exposing their body parts for diagnosis. Anticipation for MASTOCHECK was especially high because it is an innovative medical technology that can enter the global market, including developing countries where limited imaging tests are available and counties with Arabic culture where people are reluctant to expose their bodies.

NET certification is a system run by the Ministry of Health and Welfare to discover new, domestic technology in the early stages of development. NET certifies technology’s excellence, promote its commercialization and technology transfer, and improve product reliability to support the technology to establish a base for initial market entry. A NET certification mark is granted after certification review in a total of seven fields (▲ Biotechnology, ▲ Food hygiene, ▲ Medical science, ▲ Medical devices, ▲ Drugs, ▲ Chinese medicine and ▲ Cosmetics), and various benefits are provided, such as ▲ Preferential treatment for projects supported by the Korea Health Industry Development Institute, ▲ Support for marketing including promotion in relevant exhibitions, ▲ Finding and providing overseas technical information, ▲ Technical assistance and support for acquisition of domestic and overseas quality certification and ▲ Requests for government agencies and local governments to purchase NET products on a preferential basis.4  

Recently there are more additional practical benefits to promote the use of NET products. From 2017, the usage of and support for NET-certified products include the annual evaluation of institutions designated as research-oriented hospitals to encourage end buyers, such as hospitals, for preferential purchase. Additional support measures have also been taken such, as the provision of 5% more funding than the determined amount for NET-certified technologies, without relying on an assessment table when filing a claim.

“License from the Ministry of Food and Drug Safety and New Excellent Technology certification, and nomination as a First Penguin-type Start-up Business are an indication that our proteomics-based early-stage diagnostic technology, MASTOCHECK, is an innovative breast cancer solution. And I am very grateful for these recognitions from the public," said Seung-man Han, CEO of Bertis. He also added that the introduction of the New Health Technology Assessment Certification by the Ministry of Health and Welfare and the National Evidence-based healthcare Collaborating Agency (NECA) led to institutional improvements that directly established the high-quality medical services system for the public. Thoughtful support from the Biohealth Innovation Start-up Center and the Comprehensive Support Center for Medical Device Industry from the initial application stage has also been a great help in acquiring this certification.” He added, “As we have an opportunity to attract continuous interest and receive fair and prompt support from relevant institutions through this certification. We will try our best to be a model case befitting the state system intent of providing high-quality medical services to the public and supporting the growth of companies.”

Meanwhile, the previous breast cancer blood tests are not adequate for early diagnosis because of low accuracy due to the use of a single biomarker. MASTOCHECK, however, has many advantages, such as consistent accuracy in diagnosis regardless of whether the subject has dense breasts or non-dense breasts and zero risks from radiation exposure, because it uses multi-biomarkers.

MASTOCHECK is expecting to become an innovative diagnosis solution that will overcome the limits of existing breast cancer screening methods and contribute to the promotion of early diagnosis of breast cancer. MASTOCHECK has high sensitivity and accuracy in diagnosis, as it is based on multi-biomarkers, compared to other diagnosis methods that use a single biomarker. It also makes it very easy and convenient to diagnose breast cancer as it uses patients’ blood. In recognition of these features, MASTOCHECK received a patent by the Korean Intellectual Property Office in 2014, and it currently has nine patents from four countries—Korea, the U.S.A., China, and Japan. Also, MASTOCHECK obtained a license from the Ministry of Food and Drug Safety as an in vitro diagnostic medical device in January 2019 based on its proven efficacy in the early diagnosis of breast cancer.