Speclipse
Shaping a New Paradigm in Cancer Diagnosis

In the current scenario, surgical tissue biopsies are considered the gold standard for cancer diagnosis. Different types of cancers are now molecularly profiled to aid in treatment decisions and outcome-based predictions. However, as genotyping of tissue has inherent limitations, oncologists continue to face the constraints of tumor heterogeneity. Genotyping of tumor cells only represents a single snapshot in time and is subjected to spatial selection bias as therapeutic options are based on a patient’s tumor genomic profile. The parts within a tumor can present a related but different genetic and epigenetic profile. These characteristics can dynamically evolve, driven by microenvironmental stimuli and clonal selection under treatment pressure, rendering therapeutic decisions based on historical tissue biopsy suboptimal.

Furthermore, tissue biopsy procedures are constrained by accessibility, repeatability, patient age, cost, and time with possible harmful clinical complications. In a recent survey, it has been reported that a lung biopsy costs on average $ 14,587, which does not include the additional expense of complications from the surgery, reported in 19.3 percent of patients; the average prices go up to $ 37,745. Due to the inadequacies of tissue biopsy, liquid biopsy has emerged as a novel, non-invasive method of detecting and monitoring cancer. It offers a significant step forward because of its less invasive nature, lower cost, real-time insights into tumor status, and, in some cases, the ability to overcome the issue of tumor heterogeneity or multiple metastatic lesions. The ease of use and increased availability of liquid biopsies will benefit more patients over time.

Observing this imperative need—Speclipse has pioneered the world’s first skin cancer diagnostic solution based on laser-induced plasma spectroscopy (LIPS) and artificial intelligence (AI) technology. The company is at the forefront of accomplishing this mission by repurposing its core product, Spectra-Scope, and diversifying its applications.

Overcoming the Challenges of Conventional Liquid-Biopsies

With the recent developments in next-generation sequencing (NGS)-based technology, the minimal invasiveness, accuracy, and time resolution for early-stage cancer are attractive features of liquid biopsy-based on ctDNA (circulating tumor DNA). Although ctDNA analysis can be challenging, collecting sufficient quantities from a single type of analyte is a troublesome process. The substitutions caused by DNA damage and somatic mutations originating from normal cells still pose hurdles to detecting mutations on ctDNA. Furthermore, clinical studies indicate that detecting ctDNA mutations alone requires impractically large input volumes of plasma to allow sufficient copy numbers of ctDNA-derived mutations in early-stage cancer. Also, detecting low allelic frequency mutations in a broader gene panel increases the risk of false positives. The other category of liquid biopsies circulating tumor cells (CTCs) are cellular analytes and offer the advantage of containing RNA, DNA, and protein from the tumor cells, with a spatial resolution of biomarkers (e.g., nuclear versus cytoplasmic), which is unattainable from ctDNA or exosomes. However, CTC analysis can yield important information on the metastatic process; its heterogeneous nature enables only a tiny fraction of CTCs to appear capable of colonization and metastasis. In addition, as some cancers release a limited number of these cells into the circulation, the CTC method may appear to be suitable for evaluating only late-stage diseases.

Speclipse’s Spectra-Scope has helped vastly improve skin cancer diagnosis by providing a high level of efficiency and accuracy in detecting biochemical information pertaining to skin tissue through laser-induced plasma spectroscopy (LIPS).

We are exploring using our core laser spectroscopy and deep learning algorithm technology to diagnose other forms of cancer by extracting bio-marker information from the tissue in real-time

In 2020, MedTech Outlook Magazine sat down with Dr. Sung Hyun Pyun, CEO of Speclipse, to discuss the medical device developer’s patented non-invasive, in-vivo cancer diagnostic solution. He also spoke about how the previous year added a feather to the company’s cap when they got CE Mark of Europe and Therapeutic Goods Administration (TGA) approval of Australia, displaying its products quality, safety, and efficacy for the respective markets.

Since then, Speclipse has focused on extending its commercial execution by forging partnerships with local product distributors to engage in sales activities. The company has expanded into Latin America through the Brazilian market by acquiring ANVISA approval. To make more considerable strides this year, Speclipse aspires to obtain FDA approval as well shortly. In the latest exclusive interview with Dr.Pyun and COO of Speclipse, Sean Min, we discussed how the company has continued enhancing and expanding its solutions portfolio. “We are exploring the use of our core laser spectroscopy and deep learning algorithm technology to diagnose other forms of cancer by extracting bio-marker information from the tissue in real-time,” begins Dr.Pyun.

Raman scattering has been touted to be a promising investigative and diagnostic tool for cancer detection in recent years. Owing to its high chemical specificity and non-invasive detection capability, SERS has been widely employed in cancer screening, diagnosis, and intraoperative surgical guidance. That said, its translation for wider clinical use involves developing comprehensive spectral databases and tissue classification methodologies that can be compared with current gold standards. This is where, Speclipseshines through, applying SERS’ concept in its core solution—SpectraScope. “Our solution uses surface-enhanced Raman scattering spectroscopy (SERS) to enable oncologists to view molecular structure inside the blood,” COO of Speclipse, Sean Min. Using fiber-optic-based light delivery and collection, the company aims to uncover the molecular basis of cancer by providing objective, quantifiable molecular information for diagnosis and treatment evaluation. “We take advantage of the high sensitivity and specificity of SERS, which leads to fast and accurate differentiation between malignant or premalignant tissues from normal tissues in cancer detection,” adds Dr.Pyun.

Furthermore, Speclipse has adopted and developed a robust database for processing, acquiring, and classifying information, leading to high accuracy in both sensitivity and specificity of malignant tissues. The Spectra- Scope incorporates a deep learning-based diagnostic algorithm that ensures real-time assessment and aids in preprocessing the raw data and eliminating unwanted signals to produce accurate qualitative and quantitative analysis. Speclipse utilizes deep-learning training using large numbers of spectra to help identify molecular patterns among cancer types, aid in margin detection, and serve as predictors of the aggressiveness of cancer. The company’s diagnostic algorithm was constructed by a deep neural network, trained with emission spectra, differentiating the conditions of BCC, SCC, and malignant melanoma with more efficiency and accuracy than conventional liquid biopsy methods.

Commitment to Innovative Excellence in Medical Technology

Today, with the rapid pace of innovation and technological advancement, considerable progress has been made in the field of oncology liquid biopsy, with the number of tests available to clinicians growing every day. While obstacles to the prominent adoption of liquid biopsies are not trivial, the promise it holds is undeniable since they offer several advantages in addressing issues related to conventional biopsies. Increasingly sophisticated technologies with non-invasive nature and real-time assessment have enabled clinicians to monitor potential disease progression and therapeutic intervention much efficiently. In conjunction with these emerging trends, Specilpse was established in 2015 by Dr. Sung Hyun Pyun, collaborating with a renowned dermatologist to bring forward transformational, robust, next-generation content-rich cancer diagnostics for early-stage detection. Since its inception, the company has been committed to providing innovative medical technology to assist in challenging diagnosis cases with the mission to continually enhance its technology and enable oncologists to improve treatment based on accurate diagnoses. Dr. Pyun, a graduate from Stanford University with an MS and Ph.D. in Mechanical Engineering, always had an affinity for medical device engineering technology. While working with the National Labs of South Korea, he stumbled upon the idea of using cutting-edge laser spectroscopy technology to analyze the chemical composition of seafloor rocks in real-time. Fuelled by his desire to create progress in medicine, Dr.Pyun was intrigued to study the human tissue to see if it was possible to identify the malignancy of tissues with spectroscopy technology; in doing so, he experienced great success.

“When I further looked into the skin cancer diagnosis market, it showed an opportunity to help people who suffered from the disease,” says Dr.Pyun. He later presented his research results of tissue analysis in the symposium between the Korea Institute of Machinery &Materials and Seoul National University Hospital. “A professor in the dermatology department approached me and suggested that it could be used to detect skin cancer in its early stage,” adds Dr.Pyun. Thus, Speclipse was born.

Growing over the years, Speclipse has disrupted the skin-cancer diagnostics space with its Spectra-Scope product by reducing visual diagnosis. The company is catering to a wide range of skincare clinics that currently conducts skin check-up or/and skin biopsy. Now, the company is focusing on expanding the second-generation and third-generation models of its core offering based on end-user feedback. Speclipse plans to introduce a new imaging modality technology and an enterprise solution that would help clinics streamline the additional information seamlessly into their operations. Moving forward, the company is also investing its resources in expanding the applications of its Spectra-Scope and AI technology soon. Speclipse is working with Seoul National University Hospital on applying its solutions in blood analysis to detect biomarkers of other cancers such as gastric, breast, and pancreatic cancers. In addition, researchers are also looking at using the technology to detect Alzheimer’s disease in the early stages potentially.