CytoReact Technology

Technology of CytoReact
A Predict Marker of HPV Infection Relative Spontaneous Regression

The Over-Diagnostic & Over-Treatment for Cervical Dysplasia:
◙ Although many dysplasia lesions are known to regress without treatment. However, women with dysplasia are usually
treated because we cannot predict which dysplasia lesions will regress spontaneously

◙ Currently, the most aggressive standard of care for dysplasia is immediate colposcopy and biopsy of all suspected
lesions. This type of aggressive management is expensive with some associated morbidity, and most of them represents
over-treatment, since evidence indicates that most cases of ASCUS and LSIL eventually regress. Most dysplasia cases
do not need immediate primary treatments.
◙ Millions of women were Under Over-Treatment due to this confuse and anxious such as Tissue biopsy; Cryosurgery ;
Electrosurgery; Laser surgery ; Surgical removal and even immune response modifiers or the cytotoxic agents
medications.
◙ 9 million colposcopies are performed annually worldwide on patients with abnormal Pap test results, but only about
20% reveal cervical cancer or pre-cancerous conditions. only two percent of patients who test positive for HPV will
eventually contract cervical cancer.

The Predict Marker of HPV Infection Relative Spontaneous Regression:

◙ HPV is almost 100% positive of cervical lesions. All recent studies demonstrated that locally chain cellular immunity is
the most important in the control of HPV infection and development of dysplasia. Infection with HPV induced a type-
specific cellular immune chain responses, mainly direct against the major capsid protein L1. Cyto-toxic T cell and helper
T cell be able to recognize the HPV L1 antigen presenting cells and elicit special T (Th1/Th2)immune response to kill
these infected cervical cells.

◙ Inflammation is one of the first responses of the innate immune system to infection. However, HPV infection do not has
the symptoms of inflammation since HPV still keep inactive before maturity. The L1 capsidprotein of Human Papilloma
Viruses (HPV)is a nucleoprotein antigen, and it will be rapidly transported into the lower layer nucleu of the host cells
(malignent HPV infection)or the fast prolifration superfacial cervical cells (benigh HPV infection)after it is synthesized in
cytoplasm of the host superfacial cells. Therefore only a nuclear staining is a specific staining. The forming of HPV L1
protein and T cells-MHC complex is ON and OFF reaction, one complex will trigger an high concentration of local cellular
immune-response.

◙ Worldwide, near 630 million HPV infected individuals each year. Average HPV duration of infection was 8 months, 80%
of infections were cleared within one year, only 9% showed persistent infection after 2 years. Most infections are
transient and are cleared spontaneously by the immune system. Except persistence HPV infection or deep micro-trauma
infection and women with immune problems such as Steroid medications, Transplanted organs, Chemotherapy and HIV.

◙ The average positive rate of sub-clinical HPV infection (LBC negative) is about 98%; The average positive rate of LSIL
/CIN I cervical dysplasia is about 30-70%; The average positive rate of HSIL /CIN II cervical dysplasia is about 12-40%
and cervical cancer (CCS) is abut 0% positive rate.

State Art of Technology:

Combined In Situ Hybrid detection of HPV L1 protein binding specific site on DNA probe with the Immunohistochemistry
techniques, CytoReact® — Cell/Tissue HPV Broad Spectrum L1 Kit system revolutionary applied the high-tech
engineering microsphere in the matrix of a biodegradable copolymer, and therefore is an extremely sensitive method to
recognizes the HPV L1 capsid proteins of the 28 most known cervical cancer relative papilloma viruse types in cervical
cell/tissue . This technology offers an 30 times stronger enhanced signal generating system for the detection of less
than 0.01pg (10-12 grams) antigens present in low concentrations or for low titer primary antibodies.