Singapore, 30 October 2018 – 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).

Fibroadenoma is the most common benign breast tumor in the world. Around 1 in 10 women will develop a fibroadenoma in their lifetime[1][1]. In the United States, nearly one million fibroadenomas are diagnosed each year[2][2]^,[3][3]. 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.

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 commercialisation arm ETPL for development as a clinical assay globally.

“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 healthcare 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 today to mark Breast Cancer Awareness Month in October. 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 per cent of all cancers among women in Singapore.

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

About Lucence Diagnostics

Lucence Diagnostics is a genomic medicine company focused on personalizing cancer care. Headquartered in Singapore with offices in San Francisco and Hong Kong, Lucence invents genomic-based diagnostic tests that enable cancer screening and treatment selection. Lucence’s tests target the most common cancers in Asia using proprietary technology and clinical analytics. Its key operations are supported by an ISO15189 accredited molecular diagnostics laboratory and a cancer genetics clinic. For more information, please visit www.lucencedx.com.

About Singapore General Hospital

Singapore General Hospital, a member of Singapore Health Services, is the public sector’s flagship hospital. Established in 1821, SGH is Singapore’s largest acute tertiary hospital with 1,700 beds and national referral centre offering a comprehensive range of 39 clinical specialties on its campus. Every year, about 1 million Singaporeans benefit from medical care delivered by its 800 specialists. As an academic healthcare institution and the bedrock of medical education, SGH plays a key role in nurturing doctors, nurses and allied health professionals, and is committed to innovative translational and clinical research in her continual strive to provide the best care and outcomes to her patients. www.sgh.com.sg

About Pathology Academic Clinical Progamme (PATH ACP)

The SingHealth-DukeNUS Pathology Academic Clinical Programme comprises the Singapore General Hospital’s Division of Pathology, and the Pathology Departments of KK Women’s & Children’s Hospital (KKH), Changi General Hospital (CGH) and SengKang Hospital (SKH). Continuous research and education to deliver cutting edge pathology services that support best patient care are pivotal to the Pathology Academic Clinical Programme.

About the Agency for Science, Technology and Research (A*STAR)

The Agency for Science, Technology and Research (A*STAR) is Singapore’s lead public sector agency that spearheads economic oriented research to advance scientific discovery and develop innovative technology. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit society.

As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by contributing to societal benefits such as improving outcomes in healthcare, urban living, and sustainability.

We play a key role in nurturing and developing a diversity of talent and leaders in our Agency and research entities, the wider research community and industry. A*STAR’s R&D activities span biomedical sciences and physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis.

For ongoing news, visit www.a-star.edu.sg.

Media Contacts

Lucence Diagnostics

Elena Tan

Tel: +65 9764 2523

Email: elena.tan@lucencedx.com

Singapore General Hospital

Rachel Kelly

Tel: +65 6326 6314
Email: rachel.kelly@sgh.com.sg

A*STAR

Robin Chan

Tel: +65 6826 6281
Email: robin_chan@hq.a-star.edu.sg

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[2][2] D. Grady. Study of Breast Biopsies Finds Surgery Used Too Extensively. February 18, 2011.
[3][3] R. Greenberg, Y. Skornick, O. Kaplan. Management of Breast Fibroadenomas. J Gen Intern Med.

1998;13(9):640-645.