Partnership · Announcement

ONCO X × Biofidelity: bringing ultra-sensitive lung cancer testing to India.

ONCO X — the Molecular Diagnostics vertical of Biosite Research — has partnered with Biofidelity to bring guideline-complete, ultra-sensitive lung cancer molecular testing to Indian labs and oncology practices. The result: our PulmoSmart and LiquiSmart Lung offerings, running on standard PCR hardware Indian labs already own.

Why this partnership matters.

Precision oncology in India has been held back by three practical realities: biopsies that don't yield enough tissue for standard NGS, turnaround times that push targeted therapy weeks behind chemotherapy, and the capital cost of standing up in-house genomic sequencing in the labs that actually serve most Indian patients.

Biofidelity has spent years engineering around exactly these problems. Their ultra-sensitive PCR chemistry delivers NGS-class sensitivity from very small samples — and runs on the QuantStudio™ 5 real-time PCR platform that is already installed in hundreds of Indian molecular pathology labs.

Together with ONCO X's Indian clinical, regulatory and laboratory infrastructure — inherited from Biosite Research — the partnership makes something new practical: a guideline-complete, next-day NSCLC molecular test that actually runs where Indian patients are actually treated.

What the partnership delivers.

• PulmoSmart — 11-gene NSCLC panel on FFPE tissue, DNA + RNA in a single workflow, on standard PCR.
• PulmoSmart Prime — the same panel on a 2-day fast-track workflow, for patients who can't afford to wait.
• LiquiSmart Lung — ultra-sensitive ctDNA testing from a tube of blood, including a first-line cancer resistance test for serial monitoring on treatment.
• Ongoing joint development across colorectal, bladder and MRD indications.
• Independent validation in Indian NABL-accredited labs, building on prior validation at MD Anderson, UPenn, Medical College of Wisconsin and Fred Hutch.

What this changes for Indian oncology.

Today, an oncologist in a Tier-2 Indian city who wants a comprehensive molecular answer for an NSCLC patient often has one workable path: ship a tissue block to a reference lab, wait three or more weeks, and hope the sample doesn't fail. In the interim, treatment starts empirically — often with chemotherapy the patient would not have needed if the molecular answer had come first.

With the ONCO X × Biofidelity workflow, that same oncologist has three options: a standard tissue panel with 5-7 day turnaround, a fast-track version with a 2-day report, or a liquid biopsy that also enables serial monitoring for resistance. All three run on hardware that is already in the lab, not a million-dollar sequencer that isn't.

About the partners.

ONCO X is the Molecular Diagnostics vertical of Biosite Research, a two-decade-old Indian clinical research organisation. ONCO X focuses on making world-class cancer molecular tests practically available across Indian oncology practice — starting with lung, expanding into colorectal, bladder and MRD. Learn more at /company/.

Biofidelity is a molecular diagnostics company developing ultra-sensitive PCR-based tests for oncology, engineered to deliver NGS-class performance from very small samples on standard laboratory hardware.