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First self test for cervical cancer has received nod from USFDA

The technology marketed by Roche could increase uptake of cervical cancer screening by doing away with the pelvic examination

The USFDA has given its approval for a human papillomavirus (HPV) self-collection solution developed by Roche Diagnostics. The solution makes it possible for women to collect their own vaginal swab in a hospital setting. The sample is then tested using the polymerase chain reaction (PCR) method in the various COBAS machines developed by the company.

The self testing option is an exciting development because uptake of cervical cancer screening often suffers because of women’s reluctance to be subjected to a pelvic examination. “The HPV self-collection solution is approved for use with Roche’s cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which offers the fastest time to results, providing up to 144 results in about eight hours for the cobas 5800 System, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift,” the company said in a statement.

This is an important advancement also for India where the uptake of cervical cancer screening is very poor and the burden very high. According to the National Family Health Survey 5, only 1.9% Indian women have ever undergone screening for cervical cancer. India, it is estimated has a population of 51 crore women aged above 15 years, all of whom are theoretically at the risk of developing cervical cancer. Every year the disease affects about 120,000 women and 77,000 die of it – many of them because of diagnosis at a more advanced state. Post COVID19 pandemic India also has idle capacity in terms of COBAS machines that can be effectively used for this purpose. 

“With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach. Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing,” said Matt Sause, CEO of Roche Diagnostics.  

MediBulletin Bureau
MediBulletin Bureau
A team of experienced and committed journalists. Working under guidance of Dr. O. P. Choudhury. You can reach us at: bureau@medibulletin.com
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