INDIA – The Central Drugs Standard Control Organisation (CDSCO) has cleared Mylab Discovery’s real-time PCR kit for the detection of herpes simplex virus (HSV) in India.
The Pune-based biotech company will market its new kit under the brand name, PathoDetect kit, to detect the specific strain of this highly contagious virus in humans.
Mylab has introduced its India-made real-time PCR kit to serve as a diagnostic tool in differentiating the two main types of the herpes simplex virus, also known as human herpes viruses.
HSV, which affects a person’s physical, emotional, and psychological well-being, has no cure. However, specific antiviral medications may help reduce severe symptoms of this viral infection.
HSV type 1 is usually spread orally and it causes infection in or around the mouth (oral herpes). The common infection can also cause genital herpes.
On the other hand, HSV type 2 is primarily spread sexually and produces genital herpes. HSV-2 infection increases the probability of contracting and transferring HIV.
Mylab’s diagnostic product will give doctors in India an easy, inexpensive, and minimally invasive tool to differentiate herpes simplex virus type I (HSV-l) and type 2 (HSV-2) in a single tube.
The PathoDetect kit will provide clinicians with a highly accurate option that is less time-consuming in comparison to traditional testing methods such as virus culture techniques.
In his address, Hasmukh Rawal, Managing Director of Mylab Discovery, asserted: “RT-PCR is a highly reproducible technique. It is four times more sensitive, faster, and a labour efficient method for HSV detection compared to virus culture.”
He underscored that the PathoDetect kit will facilitate the early diagnosis of human herpes viruses, and, in turn, help patients with proper disease management and lower the risk of HSV transmission.
The product launch builds on WHO’s efforts to increase awareness about HSV infection and its symptoms, improve access to antiviral medications, and promote HIV prevention efforts for those with genital herpes.
Moreover, Mylab has expanded its comprehensive product portfolio of molecular diagnostic kits thus enabling laboratories in the Indian region to drive better health outcomes.
The biotech company has expanded its RT-PCR-based testing capabilities following the successful launch of the Covid viral RT-PCR test.
This Covid-19 diagnostic test kit is commercially cleared for manufacture by the Food and Drug Authority (FDA), the Central Drugs Standard Control organisation, and the National Institute of Virology (NIV).
The Pune-based company also introduced a first-of-its-kind kit as well as automated devices for tuberculosis (TB) and multi-drug resistance detection.
Earlier this year, Mylab joined forces with DnaNudge to develop and bring to market next-generation molecular diagnostic solutions for diabetic foot ulcer (DFU) detection.
The molecular diagnostics firm also unveiled an RT-PCR-based screening tool to detect high-risk HPV strains, which cause the majority of cervical malignancies.
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