Diagnostics

FDA Clearance of HIV Management Product

The product unitises, dried-down delivery format, eliminates the need for refrigeration, exhibits nearly 99 per cent correlation with conventional liquid format

The New Product

ReaMetrix India Pvt Ltd, a medical diagnostics company based out of Bangalore, recently launched the 'Dry Tri-T Stat' product used in HIV management, for the global market. This is the only USFDA —FDA 510(K) — cleared dried-down CD4 enumeration product available in the world today for the flow cytometry instrumentation market.

This unitises, dried-down delivery format, eliminates the need for refrigeration, exhibits nearly 99 per cent correlation with conventional liquid format and is at least three times more affordable than other products existing in the market today. Said Dr Bala Manian, CEO, ReaMetrix, "The ‘dried-down’ innovation is a successful validation of our thinking, as this is an innovation that is set to have a global impact."

According to 2008 estimates, national adult HIV prevalence in India is approximately 0.36 percent of total population, that's nearly 2.5 million people. Access to reliable, accurate and affordable CD4 testing solutions, is key in the clinical management of HIV patients. Some of the predominant issues with CD4 testing in the Indian context are the high cost of testing, poor access to testing, poorly developed cold chain for the transport, storage and use of products and a complicated work flow, requiring skilled labour. The real challenge lies in transporting blood samples from remote areas to centralised testing centers. In most cases, this leads to 'aged' blood samples (> 48 hrs), making it unusable for testing.

ReaMetrix's innovative dried-down CD4 enumeration product helps address this need. With the unitised, dried down products, the cost of the CD4 enumeration test per patient will see nearly a four-fold reduction in costs, while at the same time, producing accurate diagnosis. Blood can be collected, stained and fixed at the point of collection before being shipped to a central testing facility at room temperature. The stained samples can be stored for up to seven days at room temperate eliminating the issue of ‘aged’ blood samples.

Announcing the availability of the FDA cleared HIV management product, Dr Anand Sivaraman, Product Evangelist, ReaMetrix India, said, "Our pre-dispensed product tubes enable a simplified workflow, assuring highest accuracy and reliability. What's more, this test is being made available at less than one-third of the cost of the existing, imported liquid-format reagent products."

The ReaMetrix portfolio of products currently includes products for monitoring HIV progression, stem cell enumeration, screening patients for Ankylosing Spondylosis, and staging cancer patients.

EH News Bureau