‘AI Blood Test’ transforming depression diagnosis as U.S.-based 안전한 바카라 사이트 Biotech targets Asian expansion with Korean VC

[by Sung, Jae Jun] Ascertain Biotech, based in Chicago, USA, is spearheading advancements in the diagnosis and treatment of depression by utilizing AI-driven protein biomarker blood test technology. This initiative aims to address the sharp rise in depression cases and the limited efficacy of conventional antidepressants observed in the aftermath of the COVID-19 pandemic.

<THE BIO recently conducted a video interview with Ferdinand Belga, CEO of 안전한 바카라 사이트, to discuss the company’s technology, business strategy, and vision for entry into the Korean market. 안전한 바카라 사이트 has also been actively engaging with various venture capital firms in the U.S. and Asia.

Belga established 안전한 바카라 사이트 drawing on his extensive experience in launching global new drugs, including Humira (adalimumab), at the multinational pharmaceutical company Abbott Laboratories, as well as his leadership in emerging market operations. Following his involvement in the IPO processes of startups focused on rare disease treatment and opioid addiction treatment, Belga founded 안전한 바카라 사이트 with the aim of addressing the limitations of existing depression diagnostics, which primarily rely on subjective questionnaires.

◇Surge in 안전한 바카라 사이트 cases post-pandemic highlights risks of existing diagnostic methods

안전한 바카라 사이트 is developing a personalized treatment platform that enables the objective diagnosis of depression through blood biomarkers and AI-driven analysis, while also supporting the identification of the most effective antidepressants for each patient. The company highlights the limitations of current diagnostic approaches, which rely heavily on 'subjective questionnaires,' as well as inefficiencies of conventional drug treatments that often require significant time and financial resources. According to the U.S. 'STAR*D' study, a large-scale clinical trial conducted by the National Institute of Mental Health (NIMH) to evaluate the effectiveness of various antidepressant treatment strategies for patients with treatment-resistant depression, the initial success rate of depression treatment stands at only 36%.

Belga cited data from the U.S. Centers for Disease Control and Prevention (CDC) indicating that the number of 안전한 바카라 사이트 patients in the United States has risen from 17 million to 60 million since the onset of the COVID-19 pandemic. Furthermore, when researchers looked at the last global pandemic, Spanish Flu 1918-1920, 안전한 바카라 사이트 and mental health disorders lasted for many years after the infection.

“…the example of the influenza of 1918-1920 gives us reason to expect that the present pandemic [COVID-19] will carry in tow its own set of mental health challenges.”

“안전한 바카라 사이트 diagnosis has traditionally depended on simple questionnaires,” Belga emphasized. “This subjective approach presents serious risks to patients.”

“Additionally, when a medication fails, six months are lost, and if a second medication also fails, a full year can pass. During this period, patients remain vulnerable to the risk of suicide,” he further commented. “The core mission of 안전한 바카라 사이트 is to increase diagnostic accuracy and protect patient lives.”

◇Offering objective 안전한 바카라 사이트 diagnosis through ‘blood tests’ based on protein biomarkers

안전한 바카라 사이트 is developing a platform that quantifies depression through a blood test based on protein biomarkers, analogous to ‘cholesterol’ test, and utilizes AI to predict the antidepressant most likely to be effective for each patient. Unlike existing gene-based predictive tests, this approach analyzes proteins that are actively expressed, enabling a direct assessment of the patients’ current condition and providing objective numerical results rather than relying on subjective questionnaires. Furthermore, 안전한 바카라 사이트's AI model predicts patient's outcomes based on changes in protein levels while minimizing bias by excluding variables such as gender and race.

"We apply AI exclusively to objective, protein안전한 바카라 사이트 data," explained Belga. "This approach distinguishes us from IBM's Watson, an existing AI model that ultimately failed.”

◇안전한 바카라 사이트ming for 100,000 diagnoses in 5 years with goal of achieving FDA approval unatt안전한 바카라 사이트ned by GeneSight”

안전한 바카라 사이트 is concurrently developing four revenue models: Diagnostics, Personalized Medicine, Companion Diagnostics, and Mobile Health App (App Engagement). Among these, Companion Diagnostics is particularly well-suited for early investment recovery, as they it does not require FDA submission given that drug testing is performed on medications rather than directly on patients.

The diagnostic business focuses on objectively quantifying depression by analyzing blood proteins. 안전한 바카라 사이트 is pursuing accelerated approval and insurance reimbursement through the U.S. Food and Drug Administration (FDA) 510(k) pathway.

A key aspect of 안전한 바카라 사이트’s diagnostics service is its approach to legal risk management. The company positions itself solely as a provider of information to healthcare professionals, rather than directly ‘diagnosing’ patients. “Diagnosis and prescription are entirely at the discretion of physicians, allowing us to avoid legal liability,” Belga remarked.

안전한 바카라 사이트’s ‘diagnostic service’ is positioned competitively against ‘GeneSight’, a genetic-based test currently covered by U.S. government insurance programs. Unlike 안전한 바카라 사이트’s Diagnostic Test, GeneSight does not diagnose depression but only the genetic probability of metabolizing certain medications.

Per the GeneSight website, “The GeneSight Psychotropic test analyzes how your genes may affect your outcomes with medications commonly prescribed to treat 안전한 바카라 사이트, anxiety, ADHD, and other mental health conditions.”

“Because the US is aware of the risks in depression, GeneSight is reimbursed by Medicare and Medicaid, even without formal FDA approval, and is priced approximately USD $2,000-3,000,” Belga stated. “안전한 바카라 사이트 will pursue official approval through FDA 510(k) clearance at a comparable price point to what is on the market.”

안전한 바카라 사이트 is targeting an annual revenue of USD 300 million (approximately KRW 430 billion) in the diagnostic sector, based on 100,000 diagnostic cases within five years. This projection is described as a ‘conservative estimate’, given the significant expansion of the U.S. depression patient population from 17 million before the pandemic to approximately 60 million thereafter. “We are aiming for 100,000 diagnoses within five years,” Belga explained. “In light of the post-pandemic increase in depression cases, this represents a very conservative number.”

◇Generating immediate sales through companion diagnostics in a market accessible without FDA submission

In addition to diagnostics, 안전한 바카라 사이트 is positioning ‘companion diagnostics,’ which identify patients likely to respond to specific drugs, as a core pillar of its business strategy. Companion diagnostics support pharmaceutical companies developing antidepressants by enabling them to design clinical trials that target only the patient subgroups in which the candidate drug is expected to demonstrate efficacy.

This approach is comparable to the strategy employed by the immunotherapy drug ‘Keytruda (pembrolizumab),’ which secured FDA approval by targeting patient groups defined by the PD-L1 biomarker and has since become the world’s best-selling anticancer drug. Similarly, 안전한 바카라 사이트 plans to offer pharmaceutical companies a method to enhance clinical trial success rates by applying protein biomarker-based patient selection to the development of antidepressant therapies.

Companion Diagnostics has been the new benchmark for cancer and other difficult to treat diseases. The case study of Merck’s Keytruda versus BMS’ Opdivo is an example. Although Opdivo launched first, Keytruda used companion diagnostics to restrict enrollment of patients to those expressing PD-L1 (the biomarker which both Opdivo and Keytruda 안전한 바카라 사이트).

“We are participating in clinical trials by testing drugs, not patients,” he further expressed. “This allows us to enter the market without requiring FDA submission, and in fact, we have already completed p안전한 바카라 사이트d pilot testing for two antidepressants through a U.S. university.”

Additionally, 안전한 바카라 사이트 is developing a personalized treatment service that evaluates individual responses to various antidepressants through blood testing and AI analysis, recommending to the physician the optimal medication and dosage for each patient. The company also plans to launch a mobile health app that will allow patients to access their blood test results and receive support for depression management. Future plans include expanding the platform to offer services such as data-driven counseling, customized notifications, and connections to affiliated hospitals. “We are not merely a diagnostic company. We aim to establish a new mental health management ecosystem that links patients, doctors, pharmaceutical companies, and insurance companies,” Belga emphasized.

◇Growing interest in 안전한 바카라 사이트 market after 4 years of mentoring 안전한 바카라 사이트 startups

안전한 바카라 사이트 has consistently demonstrated interest in the Korean market. Since 2021, Belga has participated annually as a mentor for Korean startups through ‘KOSME x MATTER,’ a program affiliated with KOTRA in Chicago, USA, and has collaborated with Soundable Health and Thyroscope.

“Korean VCs have a deeper understanding of the unique characteristics of the Asian market than anyone else,” Belga noted. “Particularly in Asia, where 안전한 바카라 사이트 is often regarded as a ‘hidden disease,’ the demand for objective diagnostic tools may be even greater than in the United States.”

“Our business model operates across four key pillars: diagnostic accuracy, patient-tailored drug recommendations, insurance coverage, and legal risk minimization,” he further said. “We look forward to collaborating with Korean 안전한 바카라 사이트s to pioneer the ‘blue ocean’ of the Asian market.”