Hologic (NSDQ:HOLX) shares are down more than 3 percent this morning after a decision by an affiliate of health insurer Wellpoint that its Selenia Dimensions 3D mammography system is "investigational and not medically necessary."
HOLX shares were trading at $15.07 as of about 10:15 a.m. today, down 3.0 percent from their $15.54 close Friday.
Bluechoice Healthplan of South Carolina, a Wellpoint Partnership Plan affiliate, said the Selenia digital breast tomosynthesis system hasn’t been shown to be a significant improvement over the standard of care, two-dimensional mammography.
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"Comparative data demonstrating that DBT is equal to or better than other breast imaging technologies with regards to accuracy, sensitivity, specificity, and recall rates are lacking," according to Wellpoint. "The published feasibility and experimental studies also have not made it clear if DBT should be utilized for diagnostic, screening or surveillance purposes or if it should be used in lieu of or in conjunction with other imaging technologies. In addition to these issues, there remains some concern regarding radiation exposure and the learning curve for radiologist to accurately interpret the DBT results."
Hologic won pre-market approval from the FDA for the Selenia system in February. According to the federal watchdog agency, physicians reported a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone. Although the system exposes patients to roughly double the radiation of standard 2D mammograms, the improved accuracy caused fewer women enrolled in the studies to be recalled for diagnostic workups, according the FDA. The agency estimated the increased cancer risk to be 1.5 percent “compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography,” according to the release, noting that “there is uncertainty for radiation risk estimates.”
Earlier this month HOLX shares hit a 52-week low of $13.90. Today analysts at RBC Capital predicted that Hologic’s multiple will expand, but still dropped their price target from $25 to $17. RBC kept its "top pick" rating on the stock.
