Assays / Bloodborne infections
Bloodborne infections
Hepatitis B Panel — HBsAg, Anti-HBs and Anti-HBc Fluorescent Assay
OncoFirm’s hepatitis B program starts with HBsAg and is designed to grow into a panel that tells infection, vaccine immunity and past exposure apart on one reader.
At a glance
Targets
HBsAg first; anti-HBs and anti-HBc planned
Sample
Serum, plasma or fingerstick whole blood
Readout
Quantitative HBsAg; qualitative serology markers
Status
In development
Why it matters
Clinical context
Hepatitis B is often silent for years while it damages the liver. Knowing whether someone is infected (HBsAg), protected by vaccination (anti-HBs) or has been exposed in the past (anti-HBc) decides whether they need care, vaccination or nothing at all. A quantitative HBsAg value may also help support follow-up decisions.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
Built on field experience
Before founding OncoFirm, CEO Jonathan Adam Barash worked on HBsAg and hepatitis C rapid tests at First Diagnostic Corporation; that experience shapes this program.
A strip that checks itself
Every strip carries a fluorescent reference line of known brightness. Reading the test line against it corrects for reader and temperature drift, and the reader flags runs that did not flow correctly.
A traceable digital record
Each result is stored with the date, operator and lot, ready to share with a clinic record or laboratory system instead of being retyped by hand.
Where it's headed
Development roadmap
01
Feasibility
Antibody pairs, fluorescent conjugates and strip layout are selected and tested against the target.
02
Assay development
Strip, reagents and reader settings are optimized, and pilot lots are built.
03
Analytical validation
Precision, linearity, interference and lot-to-lot consistency are measured against reference methods.
04
Clinical evaluation and launch
Performance is evaluated with clinical samples. First release is planned for research use only, followed by regulatory submissions.
HBsAg is the first marker; anti-HBs and anti-HBc follow on the same strip format.
Development status. This assay and the OncoFirm platform are in development. They have not been cleared or approved by the FDA and are not available for sale. First products are planned for research use only. Descriptions reflect design goals, not demonstrated performance.
Partner on this assay
We welcome research, clinical, manufacturing and distribution partners. Tell us how this assay fits your work.