Diagnostics HPV Testing

Transcription

1 22 SOURCES COMPANIES: HOLX, QGEN, RHHBY, ROG VX BDX HOLX S HPV TESTING BUSINESS QGEN S HPV TESTING BUSINESS Roche Leads in HPV Platform Switches Roche s cobas continues to capture the majority of HPV platform switches from Hologic/Gen-Probe s TIGRIS, while Hologic/Gen-Probe s PANTHER is gaining traction among smaller to midsized laboratories. OTR Global s read on HOLX s HPV testing business remains mixed; the read on QGEN s HPV testing business is negative, as in the June report 9 of 22 laboratories plan to switch from QGEN s digene or HOLX s Cervista platforms Pap testing expected to decrease in 2013 yy as gynecologists follow new Pap smear and HPV testing guidelines; 42% 45% of 2Q13 Pap smears underwent HPV testing Area to Watch: Most labs would prefer 1 platform for HPV and CT/NG testing, but some adopting ROG VX s cobas, despite using another platform for STD testing KEY DATA HPV Test Market Share 2Q13 3Q13 4Q13 80% 70% 60% 50% 40% 30% 20% 10% 0% Qiagen Gen-Probe Hologic Roche Source: OTR Global BY BETH GILBERT SOURCES & BACKGROUND 22 directors and supervisors at cytology laboratories (7 at high-volume, 7 at mediumvolume and 8 at low-volume laboratories) REPEAT SOURCES 9 from OTR Global s June report, plus 2 from the January report INTERVIEWS Late August through early September AVERAGES Weighted according to the number of monthly Pap smears processed by each source We just purchased the cobas in July. We decided to go with the cobas [instead of Gen-Probe s TIGRIS] because of automation and the ability to add additional testing to the platform. One key advantage is that you can run the HPV test and test for 16, 18 at the same time. Director at a midsized cytology laboratory See last page for Important Disclosures and Analyst Certification NY SF BOS GER UK CN

2 PAGE 2 Roche Gaining HPV Market Share As noted in OTR Global s 2Q13 findings, Roche Holding AG s cobas continues to gain traction within the HPV market because of its improved pricing incentives and automation, gaining against Hologic Inc. s Gen-Probe s TIGRIS system among laboratories previously undecided on platform switches. We just switched to Roche. The cobas 4800 tests for 14 types of HPV, has internal controls unlike [Qiagen N.V. s] digene Hybrid Capture 2 and can pull out HPVs 16 and 18. These are more likely to progress, and there is emphasis on tracking. In addition, we can do CT/NG testing on the same material with the cobas 4800 for less than we have been doing with other methods. Also, Roche was very solicitous. They had a wonderful installation and validation program; it was the best install for a new technology that I ve experienced, one director said. Another said, We just switched from Hologic s Cervista to Roche s cobas. We went live at the start of August. Other key advantages driving cobas adoption include ease of use, smaller sample requirements and the ability to run additional testing at the same time. We had been deciding between Roche s cobas and Gen-Probe s TIGRIS but decided to go with Roche s cobas. We just purchased the cobas in July. We decided to go with the cobas because of automation and the ability to add additional testing to the platform. One key advantage is that you can run the HPV test and test for 16, 18 at the same time, one director said. Another said, We want to switch to the cobas because it will give us genotyping ability and it also has an internal control. There are also other issues. The digene requires greater volumes; you need at least 4 ml, and sometimes we only have 2 ml. In this case, we have to tell the doctor we couldn t perform the test due to technical reasons. The cobas requires smaller volumes. Because of these advances, Qiagen s market share with digene and Hologic s market share with Cervista are expected to decrease in the 2H13. Overall, nine of 22 laboratories plan to switch from Qiagen s digene or Hologic s Cervista platforms. Three laboratories using Hologic s Cervista platform plan to switch or have switched from the platform because of the availability of automated platforms, including two to Roche s cobas platform (3Q13) and one to Gen-Probe s PANTHER platform. We just switched to Roche. The cobas 4800 tests for 14 types of HPV, has internal controls unlike [Qiagen N.V. s] digene Hybrid Capture 2 and can pull out HPVs 16 and In addition, we can do CT/NG testing on the same material with the cobas 4800 for less than we have been doing with other methods. Also, Roche was very solicitous. They had a wonderful installation and validation program; it was the best install for a new technology that I ve experienced. Director of previously undecided laboratory Monthly Pap Smears HPV TESTS PLANS TO SWITCH? TIME FRAME STD TESTS PLANS TO SWITCH? 3,250 Hologic Cervista Gen-Probe PANTHER 3Q13 Gen-Probe PANTHER No plans 2,000 Hologic Cervista Roche cobas 3Q13 In-house LDT Roche cobas (3Q13) 2,000 Hologic Cervista Roche cobas 3Q13 BD Viper No plans In addition, six cytology labs plan to switch from Qiagen s digene, which includes two to Roche s cobas platform (one in 1H14), one to Gen-Probe s PANTHER platform (in 4Q13), one to Gen-Probe s TIGRIS platform (in 1H14) and another who is undecided on a vendor but plans on switching during 4Q13. Although most laboratories would prefer to have one platform for both HPV and CT/NG testing, some laboratories have been using one platform for STD testing and adopting another for HPV testing, which is consistent with OTR Global s June report. Monthly Pap Smears HPV TESTS PLANS TO SWITCH? TIME FRAME STD TESTS PLANS TO SWITCH? 20,833 Qiagen digene Gen-Probe TIGRIS 1H14 Gen-Probe TIGRIS None 5,500 Qiagen digene Undecided on vendor 4Q13 Gen-Probe TIGRIS None 4,000 Qiagen digene Gen-Probe PANTHER 4Q13 Gen-Probe TIGRIS Gen-Probe PANTHER (4Q13) 1,000 Qiagen digene Roche cobas Gen-Probe TIGRIS None 1,000 Qiagen digene Qiagen digene None 850 Qiagen digene Roche cobas 1H14 BD Viper None

3 PAGE 3 As in previous findings, calling out specific genotypes remains limited among physicians and laboratories. Genotyping is set up here, so as a routine, if a Pap smear is negative but is HPV-positive, we automatically perform 16/18 genotyping. Around 2% of our samples undergo genotyping, a director said. Another said, Genotyping hasn t been widespread. I don t think there is enough understanding about it; I think the labs will be the ones to promote the benefits of genotyping. GENOTYPING REMAINS LIMITED PANTHER Expected to Gain at Lower-Volume Labs Recent approval of Hologic/Gen-Probe s PANTHER platform for HPV testing may expand use of the platform among some small- to mid-volume laboratories using the platform for STD testing. We had been planning to convert over to the PANTHER platform for HPV testing in the middle of August, but it looks like it will be closer to the middle of September, as we are waiting for the company to come and do some training with us before we completely switch over. We are also already doing CT/NG and trichomonas testing with the PANTHER platform, one director of a mid-sized laboratory said. Gen-Probe s TIGRIS platform is expected to continue experiencing increased pressure from Roche s cobas platform, even with the company s strong presence in the STD market. Genotyping is still quite new; doctors don t request it very often. One small problem with switching to Gen-Probe is that we would have to perform another assay if genotyping is requested. A major hospital has chosen to go with Roche, which performs 16/18 genotyping, so we anticipate a lot of marketing regarding the benefits of 16/18 genotyping. If this happens and doctors request genotyping, we will have to develop an algorithm in order to provide this, one director said. One large laboratory is expected to switch to the TIGRIS platform in early Currently, we have the Qiagen digene platform, but we are in the process of switching to Gen-Probe s TIGRIS platform. Gen-Probe s appeal is that it has a long history of producing robust platforms for other infectious diseases, such as CT/NG. I they have put a lot of work into their HPV platform and have spent years validating it. It is also able to determine whether the HPV genome has integrated into the host, which Roche, for example, does not have the capacity to do. This, theoretically, correlates with progression into cervical cancer. Also, digene is performed manually, and with our test volumes, using the TIGRIS should save us a lot of time. It will also help mishandling of samples, one director said. Pap Smear Volumes Continue to Decline As in OTR Global s June findings, most cytology laboratory directors expect 2013 Pap testing to decrease yy. Due to changes in the screening guidelines and pressure on family-planning clinics, our volume has gone down. I would imagine everyone s volume has gone down over the last few years. We are doing around 2,000 a month, and it continues to drop, said a midsized cytology laboratory s director. Another said, Our Pap smear volumes have continued to decline, and I don t expect that to change that much. However, our HPV volumes have remained the same. The time between Pap smears is extending due to the new guidelines, and it is starting to impact volumes. I expect the interval between Pap smears to increase more and testing to continue to drop. A few sources noted some slight seasonal fluctuations in Pap smear testing during the year. There are some slight fluctuations in Pap smear volumes, depending on when doctors are out on vacation and during the summer; then, we see a decline, one director said. Another said, It goes down around the holidays and increases after. It is moderately steady during the warmer months. I m sure there is more fluctuation, but that is what I notice. We had been planning to convert over to the PANTHER platform for HPV testing in the middle of August, but it looks like it will be closer to the middle of September, as we are waiting for the company to come and do some training with us before we completely switch over. We are also already doing CT/NG and trichomona testing with the PANTHER platform. Director of a mid-sized laboratory

4 PAGE 4 More than one-half of cytology labs use Hologic s ThinPrep, but three use Becton Dickinson and Co. s SurePath (including one who uses it exclusively), and two use traditional approaches infrequently. Both ThinPrep and SurePath are used at our institution. Specimens are co-collected using both ThinPrep and SurePath, and the SurePath sample is sent to cytology, while the ThinPrep vial is sent to use for further testing, one director said. As in OTR Global s previous findings, a couple of laboratory directors expect their ThinPrep volumes to increase as they move away from using SurePath and move toward ThinPrep. We were conventional and ThinPrep until a few years ago; now, it is 95% ThinPrep and 5% conventional. We never have done SurePath, one director said. HPV Volumes Relatively Stable Cytology lab directors and supervisors expect the percentage of processed Pap smears that also undergo HPV screening to remain relatively stable (at 42% 45% on average) through 4Q13. Our Pap smear volumes have remained relatively steady. I haven t seen much of a change in the last several months, and I expect that to remain the same through the end of the year, a midsized cytology laboratory s director said. A few sources expect HPV volumes to increase slightly in the short term as more physicians start performing more Pap smear and HPV co-testing upfront. However, volumes are expected to decrease because of the extended intervals between Pap smears and HPV testing. If doctors practices stay the same, then our volumes should be similar. If more physicians change to co-testing on all patients, then our volume would be up for the first year of the change in practice and then down for two years, said a large cytology laboratory s director. Eventually, a few sources expect cytology screening that includes HPV testing to replace Pap smear use. I believe the HPV typing and testing is the way forward and that it will eventually replace cytology, one director said. Another said, I think that the volume of Pap smear tests will eventually fall. The algorithm will probably change from one of visual examination of cells to a lab analysis of the DNA present. If doctors practices stay the same, then our volumes should be similar. If more physicians change to co-testing on all patients, then our volume would be up for the first year of the change in practice and then down for two years. Large cytology laboratory s director. Contributors: Jason Tremble and Charlotte Waterworth NY SF BOS GER UK CN

5 PAGE 5 ADDITIONAL QUOTES ON PAP AND HPV TESTING Our Pap smear volumes have been slowly decreasing, but our HPV testing volumes have been increasing. The number of Pap smear tests we are processing is trending down, along with the number of HPV tests and CT/NG tests. This is the first time I am noticing a decrease in HPV volumes, as well as CT/NG volumes. I am not exactly sure what is going on or what is contributing to the decrease. For HPV, it could be due to the guidelines changes taking an effect, but it doesn t make sense for CT/NG testing. The number of Pap smear tests we process is definitely decreasing. We used to process 22,000 per year. But this decline has more to do with price than anything else. We cannot compete on price compared with the commercial labs. I think Pap volumes will go down year to year as more patients and physicians accept the screening guidelines. Pap tests have been the best screening test; their strength is in the repeating. But if we repeat Pap tests too often, we pick up transient HPV infections, and we don t want that. Our ThinPrep volumes are decreasing, and I expect them to continue to decrease due to changes in guidelines. There is no seasonality in the number of ThinPrep samples we process; it s pretty consistent from month to month. ON SWITCHING HPV PROVIDERS We switched to Hologic s Cervista at the end of June this year. We had been using Qiagen s Hybrid Capture II. When we were looking at making the switch, we looked at all the next-generation HPV tests and chose Cervista on the basis that it has an internal control and that it is FDA approved across the board. We also wanted to see if we could improve specificity. We use the Roche cobas 4800 as it gives you three answers on one run of the machine and on one aliquot. And, [it] can single out 16 and 18, giving you a separate answer for each. We currently have digene Hybrid Capture II, but we are looking to switch to Roche s cobas. We are using Qiagen s digene platform for HPV testing and have no plans to switch vendors at this time. We have thought about switching to newer platforms that offer genotyping, but physicians are not requesting specific genotypes that much for us to make the switch. Once it is more well accepted and approved by insurance, we will likely switch, but not at this time. ON GENOTYPING The clinical accuracy between the different platforms is about the same, and I don t think the newer platforms offer us anything better at this time. While you would think that the focus would be one more specific genotyping, including gaining insight into whether a patient has 16, 18 or 45, that really hasn t been the case. You would also think with doctors pushing out testing to three or five years that they would want to if patients carry these specific genotypes, but we haven t gotten to that point yet, which is why we haven t switched over to one of the newer platforms that offer these capabilities. I think there is still some debate over best practices. Only a few doctors are requesting genotyping. I have one doctor who requests genotyping on Pap smears that come from 19-year-olds. It s ridiculous. I ve told him it s not necessary, but he won t listen, so I have given up. We have received 15 requests for genotyping in the past six months.

6 PAGE 6 TALLY 1. How many Pap smear tests do you process in an average month? More than 2,000: 10 1,901 2,000: : : : : : 1 Total: 90, Do you expect the number of Pap smear tests processed to increase, decrease or remain the same during 2013 yy? Flat: 10 Down: 6 Down 1% 5%: 1 Down 6% 10%: 2 Down 16% 20%: 2 : 1 Weighted average: Down 8% 11% June average: Down 7% 10% 3. What was the approximate breakdown on Pap smear tests among ThinPrep, SurePath and traditional during 2Q13? What do you expect those percentages to be during 3Q13 and 4Q13? THINPREP 2Q13 3Q13 4Q13 91% 100%: % 90%: % 80%: % 70%: %: : Weighted average: 93% 96% 93% 96% 93% 96% SUREPATH 91% 100%: % 40%: % 20%: %: : Weighted average: 4% 7% 4% 7% 4% 7% TRADITIONAL 1% 10%: %: : Weighted average: 0% 1% 0% 1% N/A

7 PAGE 7 TALLY 4. What percentage of the Pap smear tests processed in your laboratory underwent HPV screening in 2Q13? What do you expect that percentage to be during 3Q13 and 4Q13? 2Q13 3Q13 4Q13 91% 100%: % 50%: % 40%: % 30%: % 20%: % 10%: : Weighted average: 42% 45% 42% 45% 42% 45% 5. What HPV tests do you use in your laboratory? (One source gave more than one answer.) Qiagen s digene: 12 Hologic s Cervista: 7 Gen-Probe s TIGRIS: 3 Roche cobas: 2 6. Have you recently or do you have any plans to switch HPV vendor? If so, which vendor do you plan to switch to? Yes, Roche s cobas: 4 Yes, Gen-Probe s PANTHER: 2 Yes, Gen-Probe s TIGRIS: 1 Yes, undecided on vendor: 1 No plan to switch: 13 : 1 7. In what time period did you switch or plan to switch HPV vendors? 3Q13: 3 4Q13: 2 1H14: 2 : 2 No plan to switch: What was the approximate breakdown among HPV tests from Gen-Probe, Qiagen, Roche and Hologic during 2Q13? What do you expect those percentages to be during 3Q13 and 4Q13? 2Q13 ROCHE GEN-PROBE HOLOGIC QIAGEN 91% 100%: % 90%: % 10%: %: Weighted average: 1% 4% 10% 13% 15% 18% 69% 72% 3Q13 91% 100%: % 90%: % 70%: % 40%: % 30%: % 10%: %: Weighted average: 4% 7% 11% 14% 19% 22% 60% 63%

8 PAGE 8 TALLY 4Q13 ROCHE GEN-PROBE HOLOGIC QIAGEN 91% 100%: % 90%: % 10%: %: Weighted average: 5% 8% 18% 21% 16% 19% 55% 58%

9 PAGE 9 TABLE Monthly Pap Smears HPV TESTING 2Q13 3Q13 4Q13 CURRENT HPV TESTS USED PLANS TO SWITCH? TIME FRAME CURRENT STD TESTS USED PLANS TO SWITCH? COMMENTS 20,833 30% 30% 30% Qiagen digene Gen-Probe TIGRIS 1H14 Gen-Probe TIGRIS None 19,000 40% 40% 40% Qiagen digene Hologic Cervista Roche cobas None - Gen-Probe TIGRIS None 85% Qiagen; 10% Hologic; 5% Roche; Adopted cobas in 2Q13 instead of TIGRIS for HPV testing due to pricing incentives 8,333 Hologic Cervista None - Gen-Probe TIGRIS None Switched from Qiagen s digene to Hologic s Cervista in 2Q13 5,500 Gen-Probe TIGRIS None - Gen-Probe TIGRIS None 5,500 30% 30% 30% Qiagen digene Undecided on vendor 4Q13 Gen-Probe TIGRIS None 5, % 100% 100% Hologic Cervista None - Gen-Probe TIGRIS None 4,000 Qiagen digene Gen-Probe PANTHER 4Q13 Gen-Probe TIGRIS Gen-Probe PANTHER (4Q13) 3,250 18% 18% 18% Hologic Cervista Gen-Probe PANTHER 3Q13 Gen-Probe PANTHER None Had planned switch to PANTHER in 2Q13 but switched in 3Q13 3,000 20% 20% 20% Qiagen digene None - Gen-Probe TIGRIS None 2,750 35% 35% 35% Gen-Probe TIGRIS None - Gen-Probe TIGRIS None 2,000 10% 10% 10% Hologic Cervista Roche cobas 3Q13 In-house LDT Roche cobas (3Q13) 2,000 Qiagen digene None - Gen-Probe TIGRIS None 2,000 50% 50% 50% Hologic Cervista Roche cobas 3Q13 BD Viper None Previously undecided on vendor; went with cobas due to automation, ability to use multiple tests on platform 2,000 Gen-Probe TIGRIS None - Gen-Probe TIGRIS None 1, % 100% 100% Qiagen digene Roche cobas Gen-Probe TIGRIS None 1,000 25% 25% 25% Roche cobas None - Roche cobas None 1,000 Qiagen digene Qiagen digene None % 20% 20% Qiagen digene Roche cobas 1H14 BD Viper None % 100% 100% Qiagen digene None - None Qiagen digene None - Qiagen digene None % 100% 100% Hologic Cervista None - Gen-Probe TIGRIS None 300 Qiagen digene None - BD Viper None Highlighted cytology laboratories above represent new sources

10 PAGE 10 IMPORTANT DISCLOSURES IMPORTANT REQUIRED DISCLOSURES Non-US persons who have prepared this report are not registered/qualified as research analysts with the NYSE and/or NASD. Such research persons may not be associated persons of the member organization and therefore may not be subject to the NYSE Rule 472 and NASD Rule 2711 restrictions on communications with a subject company, public appearances and trading securities held by a research analyst account. ANALYST CERTIFICATION The Author(s) of this research report certify that all of the views expressed in the report accurately reflect their personal views about any and all of the subject securities and that no part of the Author(s) compensation was, is or will be, directly or indirectly, related to the specific recommendations or views in this report. ADDITIONAL DISCLOSURES OTR Global LLC is an investment advisor subsidiary of OTR Global Holdings II Inc. OTA Financial Group LP is the controlling shareholder of OTR Global Holdings II Inc. OTA LLC is a registered broker dealer subsidiary of OTA Financial Group LP. The affiliated companies of the OTA Financial Group LP, OTR Global Holdings II Inc. and/or its principals, employees, clients or researchers may have an interest in the securities of issuers discussed herein or in securities of other issuers in other industries. The affiliated companies may provide bids and offers for securities of the subject company(ies) discussed in this report and may act as principal in connection with such transactions. The affiliated companies, its principals and/or employees may also hold a position (long or short) in the shares of the subject company(ies) discussed in this report. OTR does not financially compensate sources for participating in its research reports. OTR conducts industry events where sources who participated in OTR s research reports may be compensated or have their expenses paid by OTR to attend the industry event. Additionally, sources who participate in OTR s research reports may directly interact with clients at these OTR industry events OTR Global LLC (OTR). All rights reserved. This report was produced for the exclusive use of OTR and its affiliates and may not be reproduced, electronically or via hard copy or relied upon, in whole or in part, without written consent. The information herein is not intended to be a complete analysis of every material fact in respect to any company, industry or the subject discussed, nor by itself sufficient upon which to base an investment decision. OTR uses a set of symbols to represent its read: Thumb Up denotes positive, Thumb Down denotes negative, and Fist denotes mixed. These symbols are not a recommendation to buy, sell or hold a security. Additional information available upon request.