Lucence Diagnostics launches a first-of-its-kind molecular test to guide surgical approach for breast fibroepithelial tumors

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(From left) Mr Philip Lim (CEO, ETPL, A*STAR), Dr Tan Min-Han (Founder and CEO, Lucence Diagnostics and Prof Tan Puay Hoon (Chairman, Division of Pathology, and Senior Consultant, Singapore General Hospital). Dr Tan is holding up a H&E (Hematoxylin and Eosin) slide of a breast tumor tissue.

Lucence Diagnostics today announced the launch of the world’s first molecular test to distinguish breast fibroadenoma, the commonest benign breast tumor, from phyllodes tumor, a less common tumor that may be malignant. Both fibroadenomas and phyllodes tumors are classified as fibroepithelial tumors.

This test will help doctors decide how to treat an indeterminate fibroepithelial breast lump that has been detected. The FibroPhyllo™ Tissue test is based on a technology invented by the Singapore General Hospital (SGH) and the Agency for Science, Technology and Research (A*STAR).

Why is it important?

Fibroadenoma is the most common benign breast tumor in the world. Around 1 in 10 women will develop a fibroadenoma in their lifetime. In the United States, nearly one million fibroadenomas are diagnosed each year. It typically requires no treatment or the surgical removal of only the tumor. Phyllodes tumor is a less common tumor, a small percentage of which can be malignant; it may recur even after being removed.

International guidelines recommend the surgical removal of both the phyllodes tumor and its surrounding healthy breast tissue. It can be challenging to differentiate the two types of breast tumors because they share overlapping clinical and histological features. Current immunohistochemical techniques are also subjective and open to interpretation. As the prudent approach for indeterminate cases discovered on core biopsy is to treat such cases as potentially malignant, this can result in the unnecessary removal of healthy breast tissue for women.

Lucence’s new FibroPhyllo™ Tissue test addresses this problem by being able to distinguish whether an indeterminate fibroepithelial breast lump is a fibroadenoma or a phyllodes tumor on core biopsy material. The technology that underpins the test was developed over five years by a research team led by Professor Tan Puay Hoon, Chairman, Division of Pathology and Senior Consultant at SGH and Dr Tan Min-Han, then Principal Investigator at A*STAR and currently Founder and CEO of Lucence Diagnostics.

A H&E (Hematoxylin and Eosin) slide of a breast tumor tissue.

The team identified five genes with different biological functions using machine learning and found that the expression levels of these five genes could accurately distinguish between the two types of breast tumors. The FibroPhyllo™ Tissue test was validated in a cohort study of 230 breast fibroepithelial tumor tissue samples. The test was able to differentiate fibroadenomas from phyllodes tumors with an accuracy of 93%. Their findings were published in the leading journal Breast Cancer Research in 2016.

Lucence Diagnostics, an A*STAR spin-off, subsequently obtained the technology from A*STAR through its commercialization arm ETPL for development as a clinical assay globally.

The FibroPhyllo™ Tissue test is now available in Singapore, Hong Kong and ASEAN.

“The development of a molecular test that can assist in differentiating an indeterminate fibroepithelial tumor into a fibroadenoma or a phyllodes tumor reflects the commitment to research and development at the Singapore General Hospital. This research collaboration will result in faster and more effective treatment for patients. Over 9,000 women were diagnosed with breast diseases in Singapore in the past 5 years. We aim to advance breast diseases research to save more lives,” said Prof Tan Puay Hoon.

Dr Tan Min-Han said, “With the FibroPhyllo™ Tissue test, there is now objective guidance for management of the most common breast tumors that women may develop. We are excited to launch a test that has been shown to improve the diagnosis of breast fibroepithelial tumors. Lucence is fully dedicated to delivering better health care for women worldwide. This molecular test will help raise global standards of breast health, by making clear to doctors when surgery is needed and avoiding the unnecessary removal of healthy breast tissue.”

“The availability of the FibroPhyllo™ Tissue test to guide clinicians in surgical decision making today, is an encouraging result of concerted efforts between public and private sector research,” said Mr Philip Lim, CEO, ETPL, A*STAR. “We are proud to have worked with Lucence from its early days to bring the idea for this test from the lab to the market, for the benefit of patients worldwide,” he added.

The FibroPhyllo™ Tissue test was launched in October to mark Breast Cancer Awareness Month. Breast cancer is the most common cancer and the leading cause of death among women worldwide.

According to the Singapore Cancer Registry, breast cancer accounts for about 30 percent of all cancers among women in Singapore.

Source: Lucene diagnostics, SGH