Our New Test Measures True Sperm DNA Damage

There are many tests on the market offering to assess DNA fragmentation in spermatozoa: SCSA, HALO, Halosperm SCD, Helix, Acridine Orange, TUNEL, etc. They all share the same major flaw: not being able to differentiate between intrinsic (true) damage to sperm DNA and damage induced by the technique itself (artefact). Therefore, the reported number has poor, if any, correlation with clinical outcomes.

Unlike legacy tests, the True Sperm DNA Integrity Assay™ (TSDIA™) uses the same type of chemicals as nature to decondense sperm DNA, then applies AI to trace individual strands and detect breaks. TSDIA is protected by pending US and International patents. 

The TSDIA is a laboratory-developed test (LDT) offered by a CLIA- and CAP-accredited laboratory in Houston, Texas. Not available for semen samples collected in New York or California.

Using the same chemicals as nature

The image below shows a sperm cell decondensed for TSDIA scoring. Note that it looks very similar to the sperm cell on the right, which is undergoing decondensation inside a live cell.

Dozortsev et al, 1993

The image below shows a human sperm cell placed inside a living cell. Note how the DNA loops closely resemble those of the sperm cell on the left, undergoing decondensation during the TSDIA test.

Dozortsev et al, 1995

How TSDIA is performed

TSDIA is an involved, labor-intensive process. It begins with isolating motile sperm cells from the sample. The sample is then treated to make the sperm nucleus accessible to a so-called thiol reducing agent — a chemical similar to the one present in the oocyte — which gently decondenses DNA without creating breaks. The sperm nuclei are then attached to a microscope slide and stained with a dye that makes DNA appear bright blue under fluorescent microscopy. Sperm cells are manually scanned into a computer, where images are analyzed with the assistance of AI.

Please note that TSDIA test has not been evaluated or reviewed by the FDA or any other regulatory organization. It is offered as a Laboratory Developed Test and is currently available at a single location in Houston, Texas. The test is protected by pending US and international patents. We are in the process of submitting it to the FDA, and once approved, it will be made available at additional locations.

Cost

The cost of the test is $ plus shipping.

History of TSDIA

TSDIA was developed by Dr. Dmitri Dozortsev, a renown innovator in the field of human reproduction, with a long track record of important advances in both the clinic and laboratory. He began exploring sperm DNA fragmentation in 1993 and quickly saw a fundamental problem with existing tests: they rely on harsh chemicals that sperm never encounter in the body, and their results often mix true DNA damage with artefacts created by the test itself. In other words, they may not clearly show how healthy the sperm DNA really is.

Very early on, Dr. Dozortsev realized that following the natural unfolding of sperm DNA, or observing it after injection into mouse eggs, could reveal only the real breaks in the DNA. At that time, however, manually tracing these delicate DNA loops was too time‑consuming and impractical for routine use. With the arrival of powerful artificial intelligence, this final technical barrier has now been removed.

TSDIA brings together two worlds: a gentle way of unfolding sperm DNA in the lab using a compound similar to what the body itself uses, and state‑of‑the‑art AI that can “see” breaks in the DNA structure that are invisible to the naked eye. The result is a new kind of sperm DNA test that is designed to give a clearer, more meaningful picture of sperm DNA integrity than conventional methods.