HPV Testing Paradigm Flipped on its Head?

Posted on 03.13.2014 // Categories: Clinical Diagnostics

Los Angeles, CA March 13th 2014 – Some exciting news reported yesterday by the New York Times on the unanimous vote by the FDA’s Microbiology Devices Panel recommending that the benefits of the Roche cobas HPV test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks. While the FDA is not bound by the panel, the FDA tends to vote in-line with panel / advisory committee recommendations.

The entire diagnostic paradigm for HPV may now flip on its head, but it has been a long road. Developed by Dr. George Papanicolaou in the 1940s, the Pap test (also known as a Pap smear) has become the standard-of-care as a primary screening test for diagnosing cervical cancer. For nearly 50 years, the Pap test has remained relatively unchallenged as a diagnostic tool for HPV. Then in 1995, the FDA approved Digene’s Hybrid Capture HPV DNA test which really ushered in the era of molecular testing for HPV (Digene was later acquired by Qiagen in 2007). The initial indication was as a reflex test for patients with abnormal cytology as identified from a Pap test. Digene then launched a second-generation molecular HPV test and by 2003 had expanded the label to include “co-testing” with Pap tests.

But even from the very beginning the company’s stated goal even from the beginning was to establish HPV as a primary screening tool, displacing Pap tests.

“Subject to FDA and other applicable regulatory approvals, the Company plans to market its HPV test as a primary cervical cancer screening test. In doing so, the Company will compete against the Pap smear, which is the only widely used primary cervical cancer screening test”

(Digene SEC 10-K filing, 1996)

Unfortunately for Digene (now Qiagen), not only did it take 18 years for a test to reach that goal (assuming the FDA follows the panel’s recommendation announced today), ultimately the prize may go to their competitor Roche.

The question that remains is how will the FDA’s approval of an HPV test as a primary screening test impact the HPV testing paradigm and who will win / lose if it does change? Again assuming that the FDA follows the recommendation of the panel, Roche’s HPV test will become the first HPV test on the U.S. market with a primary screening indication. Despite this significant change, it will take time before it is widely adopted as a primary screening test. Clinical practice takes time to evolve. For example, it has been over 10 years since a HPV test has been approved for co-testing (Digene’s test in 2003) but current penetration of co-testing is in the 40 – 50% range.

Winners : Roche is the most likely winner as they will likely (continue to) take share from other HPV PCR competitors, most notably Qiagen (50 – 60% market share) and Hologic / Gen-Probe (~30% market share). Roche has a lot of run-away in terms of gaining market share as they are currently 3rd in the market, with only ~10% market share and neither Qiagen nor Hologic / Gen-Probe appear to be conducting trials in-line with Roche’s registration trial for their primary screening indication (Roche’s ATHENA trial enrolled ~47,000 patients with a primary study endpoint of cervical disease, not HPV infection). Roche is also well positioned in key HPV testing customers: Quest and LabCorp. While these customers have aligned themselves to some degree with specific manufactures (LabCorp / Qiagen, Quest / Hologic), Roche is unlikely to face barriers there. LabCorp currently offers the Roche HPV test and Quest has Roche cobas instruments in-house that can run Roche’s HPV tests.

Losers : Hologic / Gen-Probe is most likely the biggest loser here as they offer both PCR tests but are also a market leader in Pap tests with their ThinPrep test. Their PCR test franchise will likely face headwinds from Roche (for reasons articulated above) but equally important is that the overall Pap market is likely to be under pressure as some Pap testing moves to a reflex after primary screening with Roche’s PCR HPV test. This is a “double whammy” for a company that has positioned itself as a diagnostic company with “with an emphasis on serving the healthcare needs of women throughout the world.“ While Qiagen offers only a PCR HPV test, its HPV franchise has been under pressure from competitors for several years and Roche will only add to their challenges. Finally, BD is similar to Hologic / Gen-Probe in that it offers both a PCR test and Pap tests with their SurePath product.

Please read our blog entry to better understand why DeciBio estimated the U.S. MDx HPV market at $225M in 2013.

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Author: David Cavanaugh, Partner at DeciBio, LLC

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