Sichen Medical Launches Pan-Cancer Early Detection Test Using 10ml Blood with High Specificity and Sensitivity

Since ancient times, cancer has posed a serious threat to human health and even life.

According to the latest “Global Cancer 2018” report released by the World Health Organization (WHO), it is estimated that in 2018, more than five people died from cancer every minute in China.

In fact, cancer has a relatively long latency period. The progression from normal cells to cancerous cells, involving abnormal hyperplasia and precancerous lesions (such as various types of inflammation), to the formation of clinically detectable cancer (clinical stage) typically requires 10–20 years. More than 90% of cancers in the latency period are asymptomatic.

Furthermore, the average cure rate for early-stage clinical cancer exceeds 80%. Taking lung cancer, which has a five-year survival rate of only 19.8%, as an example, its early-stage cure rate is as high as 90%.

The critical importance of early cancer screening for life is self-evident. However, early signs of cancer are often subtle, making it difficult for conventional medical examinations—such as imaging tests, blood tumor marker assays, endoscopy, and cytology—to detect cancer signals. This limitation has resulted in the prevailing reality that most cancers are diagnosed at intermediate or advanced stages.

Previously, a similar predicament was observed in the early screening for neonatal birth defects. It was not until non-invasive prenatal testing (NIPT) was implemented in clinical practice that the screening accuracy for genetic disorders such as Down syndrome increased from 70% to 99.9%, with over 20% of pregnant women now opting for NIPT. Consequently, NIPT has become the primary arena for applications and entrepreneurial ventures in genetic testing.

Siqin Medical is attempting to achieve highly sensitive early cancer screening and accurately locate the site of cancer occurrence based on gene sequencing. Founded in March 2018 and headquartered in Shenzhen, China, Siqin Medical is a high-tech biotechnology company focused on early cancer screening. Dr. Mao Mao, Founder and CEO of Siqin Medical, is a founding member of the Shanghai National Human Genome Center. He established China’s first high-throughput DNA sequencing facility and discovered the RIG-E gene, known as “the first novel human gene cloned in China.”

Currently, Siqin Medical has launched its first pan-cancer early screening product, Sikangning™. Theoretically, Sikangning™ can screen for cancer using no more than 10 mL of blood, with a specificity of 99% and a sensitivity of 60%. Mao Mao told VCBeat (WeChat ID: vcbeat) that while gene sequencing has been maturely applied in cancer target discovery and medication guidance due to the biological association between gene mutations and cancer development, Siqin Medical focuses on applying gene sequencing to early cancer screening.

By establishing a multi-dimensional, multi-variable information entropy algorithm to analyze cancer gene mutations in cell-free DNA fragments from peripheral blood, SiKangNing™ utilizes weighted gene mutation information to diagnose and localize cancer. The relationship between the emergence of cancer and genes is intricate; if only gene mutations clearly associated with cancer are taken into consideration, some cancer signals may be missed. Mao Mao pointed out that any mutation could potentially be a signal of cancer. Therefore, Siqin Medical adopts a more systematic perspective on gene mutations and optimizes combinations of multiple markers using novel algorithms, enabling earlier and more comprehensive cancer screening.

When cancer is in its early stages, the tumor burden is minimal, and only trace amounts of circulating tumor DNA (ctDNA) are released into the peripheral blood. The most significant technical challenge for liquid biopsy is the precise detection of faint genetic mutation signals. In extreme cases, background noise can be tens of thousands of times stronger than the mutation signal. The conventional approach involves increasing sequencing throughput by repeatedly sequencing the same genomic regions to identify mutations. While this method substantially increases the workload of gene sequencing, its effectiveness in capturing weak signals remains unsatisfactory.

Siqin Medical has adopted a rather ingenious solution by taking a counterintuitive approach: it manages to reduce background noise in gene sequencing to a certain extent, thereby highlighting genetic mutations. This method achieves the effect of high-depth sequencing using less than one-tenth of the sequencing throughput required by conventional practices. Throughout this process, big data algorithmic thinking is consistently applied.

Specifically, Siqin Medical combines gene sequencing with innovative algorithms. First, individual gene sequencing results are quantified using information entropy to establish a foundational database. There are two types of fluctuations in gene sequencing data: normal fluctuations based on individual differences and abnormal fluctuations based on genetic mutations. In cancer screening, normal fluctuations in gene sequencing results are regarded as background noise, while abnormal fluctuations serve as signal sources that can provide cancer-related information.

For Siqin Medical’s noise reduction algorithm, data sources are crucial. Mao Mao told VCBeat that the data sources for Siqin Medical’s foundational database include public data extracted from academic articles and other sources, as well as data collected by Siqin Medical through scientific research collaborations. The former contributes the majority of the data in Siqin Medical’s current foundational database, with a volume reaching tens of thousands, and also serves as an important source for updating training data. In addition, self-developed R&D data is used as a validation dataset to verify the accuracy of the noise reduction algorithm in judging fluctuations.

After completing the denoising of gene sequencing data, Siqin Medical provides cancer screening results based on pre-established thresholds. Mao Mao pointed out that the principle for threshold selection is to obtain clinically meaningful screening outcomes. Specifically, Siqin Medical aims to minimize the misdiagnosis of healthy individuals as cancer patients, thereby avoiding false-positive judgments. Consequently, Sikangning demonstrates a specificity of 99% and a sensitivity of 60%.

According to Mao Mao, Siqin Medical is currently applying for a patent for an algorithm that reduces sequencing noise.。

Subsequently, based on the results of cancer screening, Siqin Medical pinpoints the specific location of cancer onset through a traceability approach. Traditionally, cancer localization is achieved via whole-body CT scans; however, this method is costly, offers relatively low resolution, and typically identifies cancer at a later stage. In contrast, Siqin Medical leverages big data and artificial intelligence algorithms for data training to localize cancer using innovative computational methods.

Specifically, Siqin Medical employs artificial intelligence algorithms in data training to identify the characteristics of biomarkers associated with different cancers. By leveraging the variations among cancers at different anatomical sites, the system traces the origin of cancer and achieves cancer localization. The localization results are determined based on the statistical probability that biomarker signals with specific variations project significantly onto particular cancer types. Mao Mao told VCBeat that Siqin Medical’s current accuracy in tracing and localizing cancer origins reaches 67%.

In terms of application, the examinee provides 10 ml of blood, and the laboratory tests are completed by the staff of Siqin Medical. After 15 working days, the tumor screening test report is generated and provided to the examinee.

Regarding product positioning, Mao Mao emphasized that Siqin Medical provides products for early cancer screening rather than diagnostic tools. “SiKangNing™ can indicate to patients that cancer is highly likely present based on algorithmic analysis and precisely identify the tumor’s location,” Mao Mao pointed out. “However, patients still need to visit a hospital for medical imaging or cytological examinations to determine whether pathological changes have occurred and to achieve a definitive cancer diagnosis.”

SiKangNing™ differs from traditional cancer screening methods by being more convenient, enabling earlier detection, and allowing for the simultaneous screening of multiple cancers. This provides examinees with a relatively better experience, while also offering higher accuracy than conventional health checkups.

It is understood that SiKangNing™ is currently marketed as a Laboratory Developed Test (LDT). Upon receiving approval for in vitro diagnostic (IVD) kits, SiKangNing™ will be launched into the market on a large scale.

Currently, over 300 million people in China undergo health check-ups annually. Among individuals aged 45 and older, more than half receive regular annual examinations. Cancer screening programs now account for more than half of all medical check-up items. Mao Mao predicts that the domestic market for early cancer screening will reach a scale of hundreds of billions of yuan, and that early cancer screening is likely to become the next blockbuster application of gene sequencing in clinical practice, following non-invasive prenatal testing (NIPT).

Mao Mao stated that Siqin Medical is planning to apply for IVD registration for Sikangning. Clinical trials are expected to commence in 2019, with the Sikangning™ series planned to be launched as an IVD product by 2021.

Currently, Siqin Medical is seeking Series A financing, with the funds to be primarily used for clinical trials and regulatory approval processes for in vitro diagnostic (IVD) products.