Cancer, one of the most life-threatening diseases, is projected to affect over 35 million people worldwide in 2050 — 77% more than the estimated 20 million cases in 2022, according to the World Health Organization. Cancer survivors globally reached 53.5 million, and the recurrence rate of the disease varies between 15% and 100%, depending on the cancer type and stage and each patient’s situation. Despite this, the world currently lacks effective solutions for diagnoses to help curb recurrence.

Enter OneCell Diagnostics, a genomics-based startup in precision oncology that aims to help cancer survivors limit recurrence instances through its proprietary cell biopsy technology.

The startup, which has served nearly 10,000 patients in India and is looking to replicate its early success in India in the U.S., has developed its in-house blood-based biopsy testing that helps detect cancer’s recurrence through circulating tumor cells. This is unlike the widely used cancer detection methods, including PET scans, CT scans, MRIs, and tissue-based diagnosis.

OneCell has secured an IP to capture and isolate the circulating tumor cell from a 10 ml blood draw. A phlebotomist visits the patient’s home to collect the blood drawn in two tubes: one for detecting circulating tumor DNA (ctDNA) and the other for detecting circulating tumor cells. These tubes are then sent to a nearby OnCell lab, where the blood sample goes through an analysis using a combination of scientific methods and AI to predict recurrence, which it calls True-Single-Cell-Multi-omics. The startup combines the circulating tumor cell DNA with its RNA and cell surface protein testing.

This helps provide better diagnosis, with at least 100 times more information than the current liquid biopsy testing, which largely revolves around cell-free DNA and ctDNA, said co-founder and CEO Mohan Uttarwar.

The startup has also developed an app called iCare, which works as a precision oncology console to help oncologists interpret test reports using AI and machine learning. “It’s the innovation at the intersection of very deep science, the cell science, and data science, and that is a perfect storm,” Uttarwar told TechCrunch.

While oncologists have the medical knowledge, they are not well-trained in precision oncology, he said. OneCell’s iCare offers a helping hand. “Our goal is that every oncologist in every hospital in every corner of the world should adapt precision oncology,” he asserted.

OneCell has developed a proprietary glass bead that uses antibodies and has an affinity toward cancer cells. This helps filter circulating tumor cells from the patient’s blood sample.

The startup provides its biopsy testing for pan-cancer analysis for all solid tumors, including breast, lung, and colon cancers. However, it deliberately avoids first-time cancer patients due to regulatory restrictions.

Companies in that domain are classified under FDA’s breakthrough category, which requires premarket approvals. India doesn’t have any such restrictions. Nonetheless, since OneCell aims to launch in the U.S., it chose to target specifically the recurrence patient market.

“Science and technology are pretty powerful and do work, but the business side of us have decided not to enter that very high-risk area,” Uttarwar said.

The startup includes Guardant Health and Natera, as well as various Indian diagnostic companies, among its competitors. However, Uttarwar told TechCrunch the precision in diagnosis and affordability, which is one-fifth the price the competition charges, makes it stand apart.

Founded in 2021, OneCell operates under the B2B2C model, offering its biopsy testing to patients through oncologists and hospitals in India. It has an office in India’s western city of Mumbai and a lab in Pune, with a headcount of 120 people. It also has 24 employees in the U.S., including those in its R&D facility in Silicon Valley.

The startup plans to start its business in the U.S. after over 2.5 years of serving India by working with biotech and biopharma companies. It has developed the test called OncoIndx Ikon to detect and analyze CTCs, which will be available in the U.S. through its local biomarker partners.

The early launch in India, one of the significant cancer-affected countries, has helped OneCell gain enough data to bolster its analytics and AI system and bring some of the top Indian hospitals on board, including state-run institutes such as All India Institute of Medical Sciences, as well as private hospitals Apollo, Fortis, and Tata Memorial Hospital. It also has strategic academic partners, including Harvard Medical School, Stanford University, and University of Georgia.

OneCell has raised $16 million in an oversubscribed Series A round led by Celesta Capital. The round also saw participation from Tenacity Ventures, Cedars-Sinai, Eragon, and Singularity Ventures. Additionally, it has added Nobel laureate James Rothman to the board.

The fresh capital will help OneCell expand into the U.S. and scale its business in India, Uttarwar said.

The startup projects to reach over 1,000 oncologists and a million patients in the near term.