Roche DNA Test
Recently the Federal health, Food and Drug Administration regulators in the US cleared the Roche HPV test to detect the Human Papillomavirus in women aged 25 and above. Roche's is primarily a genetic test that could be done as a first-choice screening option for cervical cancer. This is an advance on the decades-old Pap smear.
Roche diagnostics conducted a study that provided the FDA with reasonable assurance of the safety and effectiveness. Roche's trial included 47,000 women who underwent cervical screening using either Pap or HPV screening. The results were checked for accuracy against final biopsy results that confirmed whether they actually had cancer.
As such doctors use DNA-based tools as a follow-up to confirm Pap smear results. Now, Roche DNA test can be used as a first-choice option for cervical cancer screening, ahead of the Pap test.
The FDA approval comes despite warning from health advocates that approving the DNA test as an alternative to Pap could lead to confusion, higher costs and over treatment of younger women who carry the virus that have little risk of developing actual cancer.
While Roche supported its study results suggesting that genetic testing is more accurate and objective at identifying cancerous growth than the Pap smear, there are no major medical guidelines that recommend HPV testing alone for cervical cancer screening. Some physicians and gynecologists advice holding off using the test until medical societies can provide guidance to some key questions which include how frequently it should be used.
Pap test was the only available screening option for cervical cancer for decades. Due to increased Pap screening, in the US, the number of reported cases of cervical cancer has decreased more than 50 percent in the past 30 years. Yet, an estimated 12,000 cases of cervical cancer are expected to be diagnosed this year. Hence Roche and other test markers developed HPV tests – although the cost of Roche's HPA is twice and even more as that of the Pap which is $ 40.
The American Cancer Society has tried to evolve latest guidelines incorporating both techniques. A Pap test is recommended every three years for those aged between 21 and 29 years of age and older women should have both a Pap test and an HPV test every five years, or only a Pap every three years. Also, according to FDA, women who test positive for HPV 16 or 18 should proceed directly to colposcopy, which is an invasive procedure in which the cervix is viewed with a magnifying device and often tissue sample is collected for testing. A positive test for one or more of the other 12 high-risk HPV strains should be followed by a Pap test to determine the need for colposcopy.
As women in their 20s could be exposed to the danger of more invasive testing that could leave the cervix less able to handle pregnancy later in their life if they undergo a HPV screening, they are advised not to do so.
Roche DNA test claims to have the superior ability to detect HPV DNA and individual types. It is also capable of detecting HPV genotypes present in multiple infections. This can occur in up to 35% patient samples. It uses standardized and quality controlled reagents to do the test. Due to co amplification primer concentrations are used. This minimizes competition.
It helps identify women at risk and optimizes treatment strategies. It helps further stratify women with normal cytology who are HPV positive into different categories. The test also provides physicians with actionable information to treat the highest risk patients immediately.
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Collection of Pages - Last revised Date: January 30, 2023