Cytyc's ThinPrep and TriPath's SurePath liquid-based cytology Pap tests could receive a boost in 2003 from a positive NICE technology assessment review.

The UK's National Institute of Clinical Excellence currently is conducting a second health tech assessment evaluating the clinical and cost effectiveness of liquid-based cytology as a screening test for cervical cancer compared with conventional Pap smear testing. The institute expects to issue an appraisal in August. Cytyc and TriPath both plan to consult with NICE.

An initial review found insufficient evidence to warrant the nationwide introduction of LBC in 2000 (¹ Also see "Liquid-Based Cytology Data Insufficient To Support Nationwide Use, UK's NICE" - Medtech Insight, 12 June, 2000., p. 14). However, the 2002 publication of two sets of guidelines by the American Cancer Society and the American Society of Colposcopy and Cervical Pathology (ASCCP) highlighting LBC could bode well for a positive HTA.

The ACS guidelines, published in the November/ December issue of CA: Cancer Journal for Clinicians, recommend that LBC may be performed every two years for all women who are 21 or older or who have been sexually active for at least three years. Women ages 30 and over who have had three consecutive normal/negative screening results may be tested every two-to-three years.

The ASCCP guidelines, published in the April 24, 2002 issue of the Journal of the American Medical Association, state that LBC with HPV DNA testing are "attractive alternatives" to traditional techniques for managing women with atypical squamous cells of undetermined significance (ASCUS). The guidelines also state that when LBC is used or when co-collection for HPV DNA testing can be done, reflex HPV DNA testing is the "preferred approach" (² 'The Gray Sheet' April 29, 2002, In Brief).

In addition, Cytyc intends to inform NICE that its ThinPrep automated imaging system will increase productivity for large labs facing a shortage of cyto-technologists and a backlog of Pap smears. Using computer-imaging technology, the system assists the cytotechnologist in primary screening to interpret the test slides for primary cervical cancer screening in detecting the presence of atypical cells, cervical neoplasia, including precursor lesions, and carcinoma.

The firm said it received an approvable letter from FDA on Dec. 24, 2002 for the automated imaging and review system to be used with the ThinPrep Pap test, approved in 1996. Cytyc submitted the PMA in January. The letter is contingent upon inspection of the firm's Boxborough, Mass. manufacturing facility. The PMA application was supported by a 9,500-patient, four-site clinical trial comparing the imaging system with manual review in the detection of cervical abnormalities. Once approved, the firm plans to market to large reference and commercial laboratories with its 25-member account executive sales force.

Digene is also awaiting FDA sign-off for its Hybrid Capture 2 (HC2) human papillomavirus DNA test as a primary screen for cervical cancer. The firm had anticipated PMA supplemental approval by the end of 2002, despite an FDA request that Digene re-analyze its pivotal study data to demonstrate clinical utility (³ Also see "Digene Still Expecting HPV DNA Pap Test Primary Screen Approval By 2003" - Medtech Insight, 8 April, 2002., p. 19). Digene submitted an amended PMA supplement on Oct. 1, 2002 (⁴ Also see "Digene Infrastructure Scale-Up For DNA Pap Could Follow Failed Cytyc Merger" - Medtech Insight, 1 July, 2002., p. 28).

FDA's request was in line with a Microbiology Devices Panel 6-2 vote in favor of approval of the test with conditions - one condition being that clarification of clinical utility should be provided prior to approval (⁵ Also see "Digene HPV DNA Pap Test Impact Should Be Assessed Postmarket – Panel" - Medtech Insight, 11 March, 2002., p. 26).

If approved, Digene's test could be aided by the ACS Cervical Cancer Screening Guidelines, which call HPV DNA testing "promising" when used in primary screening. The society issued a preliminary recommendation that, if approved, "it would be reasonable to consider" that women ages 30 and over have cervical screening every three years using conventional or liquid-based cytology combined with a test for DNA from high-risk HPV types (⁶ Also see "Intervals Lengthened, Costs Lowered By HPV DNA Primary Screening – ACS" - Medtech Insight, 18 November, 2002., p. 20).

The firm also will submit additional clinical data to FDA to support an application to use the HC2 with TriPath's SurePath test pack, following receipt of a "not-approvable" letter last summer (⁷ Also see "Digene SurePath “Not-Approvable” Letter Expected After FDA Data Request" - Medtech Insight, 15 July, 2002., p. 10). The HC2 has been approved since 1997 for follow-up screening using Cytyc's ThinPrep automated cervical sample preparation system for the 5-10% of women whose Pap results show ASCUS. It is the only approved test for HPV, the virus that causes 99% of cervical cancer.

The two firms have a co-promotion pact, under which Digene pays Cytyc to promote the HC2 test for use with ThinPrep. Cytyc's 235 sales reps focus on the Ob/gyn physician office market, while Digene's smaller sales force focuses on marketing the test to lab customers. Although the two firms signed an agreement initially valued at $554 mil. to merge in February 2002, Digene pulled out of the deal last July following FTC opposition. FTC maintained the deal would lead to decreased competition and increased consumer prices within the cervical cancer screening test market (⁸ Also see "Digene Infrastructure Scale-Up For DNA Pap Could Follow Failed Cytyc Merger" - Medtech Insight, 1 July, 2002., p. 3).

On the breast cancer front, debate continued over conclusions by Nordic Cochrane Center researchers Peter Gotzsche and Ole Olsen in 2001 that no reliable evidence exists to support screening mammography (⁹ Also see "Randomized Data To Support Screening Mammography Lacking - Horton" - Medtech Insight, 29 October, 2001., p. 20).

Furthermore, the Canadian National Breast Cancer Screening Study-1, published in the Sept. 3, 2002 issue of the Annals of Internal Medicine, found that screening of women ages 40-49 with annual mammography and breast physical exams for up to five years did not reduce breast cancer deaths compared with women who had a single breast physical exam and received care from Canada's healthcare system (¹⁰ Also see "Breast Mammography Benefits Are Minimal For Women 40-49 – Annals Study" - Medtech Insight, 9 September, 2002., p. 6).

Nevertheless, the U.S. Preventive Services Task Force's updated guidelines advocate screening mammography in women over 40 every one to two years and in women over 50 every other year, citing flaws in the Cochrane study (¹¹ 'The Gray Sheet' Feb. 25, 2002, In Brief). Professional societies, including ACS and American College of Radiology, also continued to defend mammography in 2002.

The Institute of Medicine began to review the efficacy of mammography, including the findings of the Cochrane Center study, following a request by the National Cancer Institute (¹² Also see "IoM Will Evaluate Value Of Mammography In Report Requested By NCI" - Medtech Insight, 11 March, 2002., p. 14). Enrollment also continued in 2002 for the NCI's 49,500-patient study comparing digital mammography with conventional film mammography (¹³ Also see "Digital Mammography Device Cost Benefit Data Will Result From NCI Study" - Medtech Insight, 10 September, 2001., p. 10).

New technologies approved for breast cancer screening in 2002 include CADx Medical Systems' SecondLook and Instrumentarium Imaging's MammoReader computer-aided detection systems that identify and mark regions of interest on standard mammograms. R2 Technologies' ImageChecker became the first CAD technology to reach the market in November 2001.

However, Computerized Thermal Imaging received a "not approvable" recommendation from FDA's Radiological Devices Panel for its BCS 2100 thermal breast imaging system in December 2002. The firm is still hoping to receive approval conditioned on a post-market study that would presumably assuage panel concerns with the firm's data analysis (¹⁴ Also see "CTI Breast Imaging System Panel Review Falters On Retrospective Analysis" - Medtech Insight, 16 December, 2002., p. 11).

Although ductal lavage has received a mixed reception to date, Cytyc ( FirstCyte ) expects revenues of $6-10 mil. in 2003 through a series of aggressive marketing strategies. For example, the firm intends to use study results from the Women's Health Initiative showing the risk of invasive breast cancer to be 26% higher in women on combined hormone replacement therapy in order to expand the market opportunity for ductal lavage to the 6 mil. women on combined HRT (¹⁵ Also see "Cytyc Looking To Expand Ductal Lavage Franchise With Help Of HRT Study" - Medtech Insight, 29 July, 2002., p. 7). The study was published in the July 17 issue of JAMA.

Ductal lavage should benefit from a more favorable reimbursement climate in 2003 following publication of screening guidelines in the Jan. 15, 2002 issue of Cancer, which state that the procedure aids in treatment selection for high-risk women (¹⁶ Also see "Cytyc Eyes InDuct Expanded Coverage, Product Indications" - Medtech Insight, 28 January, 2002., p. 13).

Significant developments occurred in other areas of the women's health sector in 2002 as well.

Conceptus' Essure non-incisional permanent birth control device received FDA approval Nov. 4, 2002 (¹⁷ Also see "Conceptus Essure Contraceptive Approved Three Months Post-Panel Review" - Medtech Insight, 11 November, 2002., p. 16). The firm expects the device to replace tubal ligation for the estimated 700,000 women undergoing sterilization procedures annually.

BioSphere Medical became the first firm to receive clearance Nov. 22 for a uterine fibroid embolization indication with its Embosphere Microspheres , offering an alternative to hysterectomy (¹⁸ Also see "BioSphere Pitches Uterine Fibroid Embolization Alternative To Hysterectomy" - Medtech Insight, 2 December, 2002., p. 8). Boston Scientific will look for an UFE treatment indication in 2003 for its FasTracker 325 infusion catheter and Contour-PVA embolic particles.

The number of hysterectomies could also decrease due to ablation technology for menorrhagia, or excessive uterine bleeding, which accounts for 150,000-200,000 hysterectomies annually. Boston Scientific acquired BEI Medical's HydroThermoAblator for $95 mil. in May 2002 (¹⁹ Also see "Boston Scientific Sees $100 Mil. Potential In BEI Medical’s ThermAblator" - Medtech Insight, 20 May, 2002., p. 26). American Medical Systems followed suit with CryoGen's HerOption endometrial ablation technology (²⁰ Also see "AMS’ CryoGen Purchase Anticipates Expanded HerOption Applications" - Medtech Insight, 23 December, 2002., p. 5). Competing systems also include market leader J&J/Ethicon's ThermaChoice uterine balloon therapy system and Novacept's NovaSure ablation system.

Cytyc Prepares To Launch ThinPrep Imager; Women’s Health Recap For 2002

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