CEO SUMMARY: Evidence accumulates that HPV testing may be an effective way to identify women at risk for cervical cancer. Both Laboratory Corporation of America and Quest Diagnostics Incorporated recently added Digene’s Hybrid Capture® II HPV test to their menu. The intent is to offer physicians a follow-up test for patients with Pap smears that are judged ASCUS or have “borderline results.”
HERE’S A NEW TWIST IN THE RACE to improve Pap smear testing. Digene Corporation’s Hybrid Capture® II HPV test gained more respect with the publication of two new clinical studies.
Published in the January 6, 2000 issue of the Journal of the American Medical Association (JAMA), the two studies “suggest that human papillomavirus (HPV) testing may be viable for cervical cancer screening in some populations of women.”
Digene’s HPV test is approved by the Food and Drug Administration (FDA) for secondary, or confirmatory, cervical cancer testing. The FDA approval allows it to be used with Pap smears prepared with either a liquid preparation or in the conventional manner. It is not approved for primary screening or for self-collection.
Some media reports interpreted these clinical studies as a demonstration that it may soon be feasible for women to collect their own specimen for cervical cancer screening. However, medical experts involved in the studies had only observed that, in countries where a woman’s access to healthcare is limited, Digene’s HPV test might be used as a primary screen for a specimen collected by the patient.
Digene’s HPV test is designed to capitalize on the increasing evidence that 13 of the 70 types of HPV are associated with cervical cancer. A 1999 study indicates that HPV is present in 99.7% of all cervical cancers. Another clinical study demonstrated that, used in conjunction with the Pap smear, HPV testing can detect 97% of moderate or high-grade disease compared to a 76% detection rate with the Pap smear alone. (JAMA, May 5, 1999.)
With the publication of these clinical studies, both Laboratory Corporation of America and Quest Diagnostics Incorporated felt it timely to issue press releases touting the availability of Digene’s HPV test through their laboratories.
Digene’s HPV test utilizes proprietary signal amplification of antibodies to detect DNA:RNA hybrids. During 1999, Digene obtained clearance to sell its panel of women’s cancer and infectious disease tests in almost every major European country, plus Brazil and Argentina.
Liquid Prep Collection
Moreover, from a single specimen, Digene’s patented tests can detect HPV, chlamydia, gonorrhea, and herpes. It is non-invasive and can be automated on standard testing equipment. This single-sample system is cleared and available in Europe. It awaits FDA action on Digene’s 510(K) application to become available in the United States. The test can use commercial liquid Pap smear collection devices.
As a next step, Digene “intends to submit a PMA supplement with the FDA to obtain market clearance for use of our Hybrid Capture II HPV test as a primary cervical cancer screening test, either in conjunction with, or separate from, Pap smear testing.” However, the company acknowledges that data submitted to the FDA to support this application “may not be adequate to support the use of the Hybrid Capture II HPV Test as a primary cervical cancer screening test in the United States.”
Clients and regular readers of THE DARK REPORT will recognize that Digene has potentially disruptive technology. Digene’s patented technology joins that of TriPath Imaging, Inc. and Cytyc Corporation as challenging the traditional way that Pap smears have been collected and diagnosed.
THE DARK REPORT expects that Digene’s HPV test will undergo the same intense scrutiny as did the first generation of enhanced Pap smear technologies that were offered by Cytyc (ThinPrep), NeoPath (AutoPap), and Neuromedical Systems (PapNet) back in 1996.
These technologies must be battle- tested in real clinical settings before a true evaluation of their accuracy, cost- effectiveness, and ease-of-use can be made. That is Digene’s next challenge.
In the meantime, here is another example of an emerging technology with the potential to transform the way cervical cancer screening is conducted. It shows how molecular and genetic-based technology can complement, or even supplant, visual-based cytology procedures.
Viewed from this perspective, Digene’s HPV assay demonstrates how rapidly the field of molecular pathology may displace more traditional anatomic pathology procedures.
DIGENE CORP. At-A-Glance
- Incorporated: 1977
- Employees: 129
- Headquarters: Gaithersburg, MD
- Share Price: $28.00 as of 1/21/00
- Product Areas:
women’s cancer/infectious diseases blood virus
- Revenues and Net Profit (in 000s):
1999: $17.0 -$9.3
1998: $12.0 -$14.1
1997: $ 9.4 -$6.0
- Chairman & CEO: Evan Jones
- President, COO, CFO: Charles Fleischman
- Distribution agreement with Abbott Laboratories for certain products in the United States and overseas