DiaCarta--Molecular Testing

Molecular Testing

In recent years, molecular diagnostics is grown from genomic and proteomic analyses into a powerful new tool for healthcare professionals. It has been widely accepted that molecular diagnostics is superior to traditional methods, allowing for direct detection with greater sensitivity and specificity. The two emerging molecular diagnostic markets are human papillomavirus (HPV) testing and Methicillion-Resistant Staphylocccs Aureus (MRSA) screening. These markets are underpenetrated and provide lucrative opportunities for industry participants to capitalize on.

HPV, a sexually transmitted virus, has been clinically proven to be the primary cause of cervical cancer, the most common cancer among women worldwide second only to the breast cancer. This virus has been found in more than 99 percent of cervical cancers and it continues to be one of the most astounding medical findings that an infectious disease can cause cancer. Approximately 300,000 women die each year of cervical cancer despite being an essentially preventable disease. Early detection of the disease is increasingly important I managing women's health.

The current technology for the molecular testing is complex and labor intensive, also lack of specificity which generates many false positive results. In addition, the test is limited only to clinical laboratories with the resources and skilled staff that can meet the requirements set forth by the Clinical Laboratory Improvement Amendments (CLIA).

The QuantiVirus® HPV test developed at DiaCarta is an easy-of-use with better sensitivity and specificity, a total solution to meet the market need. The assay is based on branched DNA (bDNA) technology platform powered by Siemens, which detects high and low risk HPV subtypes directly from Pap smear samples without DNA or RNA purification and RT-PCR. The test is the first product focusing on oncogene E6/E7 mRNA, which gives much more reliable results for HPV early detections. The test can be performed at any regular laboratory with easy workflow. DiaCarta provides total solution for its QuantiVirus® HPV test, including test reagents, reader and software. Recently, we have obtained the clearance of the reader/software for the test from sFDA in China.

QuantiVirus® HPV test with 100% sensitivity to the pathological results.

In addition to the HPV test, DiaCarta has collaborated with Signal Diagnostics for the TB test.

The test is based on the Dynamic Flux Amplification (DFA) platform which detects using real-time, gel or ELISA formats.

DFA Test for TB	Tuberculosis (Rifampicin, Isoniazid, Ethambutol, Pyrazinamide, Streptomycin)
	Specific Tb detection: Easy-to-read Blue (Tb present); Clear (Tb absent).
DFA Test for others	Bordetella bronchioseptica (Kennel cough) Brettanomyces (Wine spoilage) Mycobacterium tuberculosis (TB, tuberculosis) Mycobacterium bovis (Bovine TB) Salmonella B (salmonellosis, food poisoning)