Viome Life Sciences Files for IPO Following $86.5M Series C Round and Reports 86% Patient Health Improvement Rate Through Screening and Intervention

Recently, VCBeat learned that digital health company Viome Life Sciences (hereinafter referred to as “Viome”) announced it had raised $86.5 million in an oversubscribed Series C financing round. The round was jointly invested by Khosla Ventures, Bold Capital Partners, WRG Ventures, and other investors. The proceeds will be used to further develop Viome’s portfolio of personalized health testing products, conduct clinical studies on gastrointestinal cancers, and support the launch of its Gut Intelligence Test at 200 CVS locations across the United States.

Viome was founded in 2016 and is currently headquartered in Bellevue, the fifth-largest city in Washington State, USA. It is an innovative company dedicated to providing personalized treatment services for patients with chronic diseases and cancer. Its founder is Naveen Jain, a seasoned entrepreneur who previously worked closely with Bill Gates at Microsoft and has founded multiple companies, including Moon Express, BlueDot, and Viome.

“Health Solutions Package” is a product tailored by Viome for patients to improve personal health and mitigate the effects of aging, including the Intelligence™ Test, personalized nutrition plans, and bio-supplements. The “Health Solutions Package” transforms traditional “one-to-many” nutritional improvement guidelines into “one-on-one” precision diagnostics and treatment, revolutionizing the concept and approach to improving patient health.

Research indicates that over 90% of human diseases are unrelated to an individual's DNA. Although DNA contains human genes, it serves merely as a static blueprint; no biological activity can occur unless the genes are transcribed. During transcription, when a segment of DNA is "switched on," it is copied into RNA molecules, which then initiate the process of translating gene sequences into functional proteins.

During transcription, a gene is read and copied into messenger RNA (mRNA) carrying genetic information; specifically, the cell synthesizes an mRNA strand with complementary bases based on the principle of base complementarity. This mRNA then carries codons to the ribosomes, enabling protein synthesis.

Metatranscriptomics is one of the approaches used to study microbiome mRNA, involving the extraction and analysis of metagenomic mRNA (the metatranscriptome). By performing large-scale, high-throughput sequencing of the transcripts from all microbial communities in samples collected under specific temporal, spatial, and conditional states, researchers can obtain transcriptomic profiles and expression levels of various microorganisms within the sample. This enables quantification of the fine-grained composition of active species across the entire microbiota and their corresponding functional expression levels, thereby identifying key biomarkers within the microbiota and elucidating their biological significance. Currently, metatranscriptomic technology has become a practical tool for analyzing the regulation and dynamics of transcriptionally active microorganisms.

Viome employs proprietary metatranscriptomics technology to study the human microbiome. By analyzing patient samples, it identifies the distribution of active species within the microbial community and characterizes their functional transcriptomic profiles, while comparing differentially expressed genes and functional pathways across varying time points, spatial locations, and conditional states. This approach ultimately elucidates the regulatory and adaptive mechanisms of the human microbiome under diverse environmental stresses, thereby uncovering the principles governing microbiome-host interactions, which are then applied to disease treatment and drug development.

Viome employs a systems biology approach, leveraging an artificial intelligence platform to analyze mRNA in order to understand the causes of disease and disease progression.

First, Viome uses metatranscriptomics technology to sequence the RNA of an individual’s entire microbial community (mRNA sequencing), thereby identifying the types of microbial populations present and their activity patterns within the human body (such as producing harmful toxins or beneficial nutrients). To date, Viome’s mRNA sequencing technology has sequenced 500 trillion RNA base pairs.

Secondly, the collected mRNA sample data is analyzed on the Vios platform to elucidate the microbiome, the human host, and the interactions between them. The Vios platform is an AI platform jointly developed by Viome using systems biology technologies and its artificial intelligence system, Vie. Viome has trained Vie using extensive scientific literature, domain expertise, biological assays, and customer feedback, incorporating data from over 20,000 clinical research cases. Vie is capable of rapidly organizing and analyzing large volumes of data, as well as providing actionable insights.

Finally, leveraging the Vios platform, Viome can compare test results with relevant disease biomarkers to gain deeper insights into patients’ health status and their risk of developing chronic diseases. Meanwhile, Viome has established more than 50 health scoring criteria for patients on the Vios platform. After data analysis, the Vios platform assigns scores to patients based on these criteria and customizes personalized nutrition plans for them.

Currently, the Vios platform has accumulated over 300,000 human samples and metatranscriptomic datasets, which support Viome in generating and testing numerous hypotheses related to chronic diseases and cancer. Based on these data, Viome’s team conducted a study showing that mRNA is associated with 80% of chronic diseases.

In addition, by integrating patient and platform data, Viome further advances the precise characterization of human gene expression and host-microbiome interactions, thereby identifying biomarkers and determining novel therapeutic targets to ultimately provide precision diagnostics and treatments for chronic diseases and cancer.

Currently, Viome has successfully developed more than 30 predictive models for conditions such as blood glucose response, obesity, diabetes, depression, irritable bowel syndrome (IBS), oral cancer, and laryngeal cancer.

Viome’s “Health Solution Package” for patients includes a range of personalized products designed to improve health, covering areas linked to overall well-being such as gut and oral health, cognitive function, heart health, digestive and metabolic health, immune system health, and even biological age.

Among them, Intelligence™ Test, Precision Supplements™, and Precision Probiotics + Prebiotics™ are the key products.

The Intelligence™ Test is a testing device designed to assess patients' health status. Upon receiving the device, patients must first complete device registration on the designated app as instructed. Next, they are required to use the specialized tools provided with the device to collect personal stool, blood, or saliva samples according to the instructions, and then mail the samples to Viome’s laboratory. Finally, patients complete an online questionnaire to provide Viome with additional relevant information. Within 2–3 weeks, patients will receive their test results, health score, and personalized nutrition plan via the app.

Throughout this process, the Vios platform captures comprehensive analytical data on gene expression within the patient’s body. Meanwhile, Viome has established health scoring criteria. Based on these analyses, more than 50 health-scoring biomarkers included in the Intelligence™ Test are mapped to the patient’s genetic data, enabling an assessment of the functional activity and behavioral patterns of the patient’s microbiome. The patient’s overall health status is ultimately presented as a composite score.

Secondly, based on the test results and health scores, the Vios platform provides patients with personalized nutrition plans, which include a 6-month individualized dietary plan as well as recommended Precision Supplements™ and Precision Probiotics + Prebiotics™.

Precision Supplements™ are nutrient capsules customized by Viome based on patients’ test results. Its formulation is “live,” capable of adapting to the varying needs of different patients at different stages. It contains more than 37 ingredients, such as 100 mg of fisetin (equivalent to 50 strawberries), 400 mg of green tea extract (equivalent to 10 cups of green tea), and 350 mg of quercetin (equivalent to 10 onions), which are nutrients commonly deficient in patients and difficult to obtain in sufficient quantities from diet alone.

Precision Probiotics + Prebiotics™ is a personalized formulation designed for patients’ gut health. Its ingredients include 8–16 strains, such as Lactobacillus animalis subsp. BI-04, Lactobacillus animalis subsp. B420, and Lactobacillus plantarum 299V, along with fiber components. The probiotic strains in the formulation were selected by Viome’s scientific team based on extensive clinical data, with each strain evaluated for efficacy and viability to ensure therapeutic effectiveness upon patient administration.

The “Health Solutions Package” specifically includes the following three products:

The holistic health solution comprises three service offerings: Full Body Intelligence™ Test, Precision Supplements™, and Precision Probiotics + Prebiotics™. The Full Body Intelligence™ Test provides a comprehensive analysis of the gut microbiome, oral microbiome, and cellular function, delivering a complete suite of health services to patients.

The Gut Health Solution comprises two service components: the Gut Intelligence™ Test and Precision Probiotics + Prebiotics™. The Gut Intelligence™ Test modulates patients’ gut microbiota balance by assessing their health status and providing personalized treatment plans, thereby reducing the risk of leaky gut and ultimately improving overall gut health.

The oral health solution comprises three service components: the Oral Health Intelligence™ Test, Precision Supplements™, and VRx My·Biotics™ oral lozenges. Among these, VRx My·Biotics™ oral lozenges provide patients with 6 billion CFU of beneficial bacteria along with other essential ingredients. Oral health is not limited to the mouth itself; it is closely linked to cardiovascular, immune, skeletal, and brain health. This product helps balance the oral microbiome, prevent oral diseases, foster a healthy oral environment, and ultimately improve patients’ overall health.

All Viome samples are analyzed in laboratories that comply with CLIA certification standards, and its manufacturer is NSF International GMP certified. Each facility undergoes compliance audits twice a year to ensure that every ingredient in the products meets regulatory requirements. Furthermore, the manufacturer’s internal laboratory and third-party testing facilities are ISO 17025:2017 certified, accredited by A2LA (American Association for Laboratory Accreditation) and the ANSI National Accreditation Board.

Data published on Viome’s official website shows that among all patients who used Viome products, 86% reported improved health in at least one area of the body, such as the oral cavity or gut; 70% perceived comprehensive health improvements across multiple body systems; and 74% chose to become Viome users after observing health improvements in other users.

In addition to the “Health Solutions Package,” Viome also offers oral and throat cancer detection tests (the CancerDetect™ Test, hereinafter referred to as “CancerDetect™”). CancerDetect™ is a cancer screening technology built on Viome’s metatranscriptomics and artificial intelligence platform, designed as an at-home testing product for detecting markers associated with early-stage oral and throat cancers. In April 2021, the U.S. Food and Drug Administration (FDA) designated CancerDetect™ as a Breakthrough Device eligible for expedited review.

Prior to using CancerDetect™ for testing, patients are required to complete a questionnaire to determine their eligibility. If deemed eligible, patients purchase the CancerDetect™ test kit, collect saliva samples at home following the provided instructions, and mail the samples to Viome Laboratories. Test results will be available online within 2–3 weeks.

Viome analyzes patient samples for the presence of oral squamous cell carcinoma (OSCC) and oropharyngeal squamous cell carcinoma (OPSCC) by examining mRNA sequences and comparing them against a biomarker database, thereby determining whether the patient has cancer.

Viome’s team conducted a clinical study analyzing saliva samples from 1,175 individuals aged 50 or older or with a history of smoking. The results showed that CancerDetect™ accurately identified 90% of cancer patient samples and 95% of non-cancer patient samples, indicating very low false-negative and false-positive rates for CancerDetect™.

Viome has raised a total of $256 million across its previous seven funding rounds. In addition to funding the research and development of products for chronic diseases, Viome has also invested heavily in the field of oncology.

In addition to oral and throat cancers, Viome is also conducting extensive clinical research on gastrointestinal cancers, including colorectal, pancreatic, ovarian, cervical, and biliary tract cancers.

By leveraging metatranscriptomics technology and its AI system, Viome is currently conducting cancer research trials using saliva, blood, stool, and tumor biopsies to gain insights into the causes of cancer onset and patterns of metastasis. Meanwhile, by identifying biomarkers associated with carcinogenesis, Viome can optimize early cancer detection and pinpoint appropriate therapeutic targets, ultimately facilitating the development of anticancer drugs.

Currently, Viome has partnered with major pharmaceutical companies and will focus on developing vaccines for colorectal cancer and autoimmune diseases in the future.