Biopsy sales shift further away from FNA to core-needle systems

May 22, 1996

New biopsy products enter competition with coreReporting on the breast biopsy wars might make one want to sortout the competing factions in Bosnia instead. Just when observersthink they know who is on top, alliances shift and new weaponsare

New biopsy products enter competition with core

Reporting on the breast biopsy wars might make one want to sortout the competing factions in Bosnia instead. Just when observersthink they know who is on top, alliances shift and new weaponsare injected into the fray. Add to that the clinical turf warbetween interventional radiologists and surgeons, and the fightover appropriate breast cancer diagnostic technology becomes evenmurkier.

Fine-needle aspiration (FNA), promoted in large part by mammographers,is the least invasive biopsy technique. Early on, it offered theprospect of inexpensive outpatient diagnosis of suspect breasttumors instead of surgical biopsy. Over the last several years,however, core-needle biopsy, which takes a larger breast tissuesample and is a more expensive procedure than FNA, has gainedground clinically.

Biopsy equipment suppliers acknowledge a continuing shift fromFNA to core biopsy among their customers in the U.S. They alsosay that the shift to core-needle techniques will spread to Europe,where FNA has its most loyal following.

FNA was recently dropped from an ongoing study of biopsy techniquesconducted by the American College of Radiology's Radiologic DiagnosticOncology Group. This fact was reported at the ACR's National Conferenceon Breast Cancer last month in Dallas.

"The goal was to find if FNA and core (needle biopsy) couldreplace open surgical biopsy," said Dr. Etta Pisano, an associateprofessor of radiology at the University of North Carolina-ChapelHill, and chair of the study. "

We dropped FNA as it became apparent that one out of three timesyou did FNA you still needed to do an open surgical biopsy. Thatis unacceptable. The answer was that FNA could not replace opensurgical biopsy."

The main problem with FNA was that it too often provided aninsufficient sample of tissue to make the diagnosis, Pisano toldSCAN. Some diagnostic centers in the U.S. have shown a lower insufficientsample rate for FNA, but this usually requires highly trainedcytopathologists, who are able to make a diagnosis by lookingat individual cells. A need for additional trained staff hikesthe cost of FNA.

"The more bodies you have in the room during a procedure,the higher the cost," she said.

The impact of a clinical shift from FNA to core-needle biopsytechniques is not large for biopsy equipment and needle suppliers.Capital equipment, such as the prone stereotactic image-guidedbiopsy tables supplied by Fischer Imaging of Denver and Loradof Danbury, CT, can use either type of needle, said Morgan Nields,Fischer chairman and CEO.

"We will go whichever way the customers want to go,"Nields said. "

If the customer wants to do FNA, we have needle holders to letthem do it. But (FNA) is not what we market. We don't think itis the best way."

FNA, however, is more apt to be used by physicians with othertypes of guidance than the stereotactic tables. A further shiftto core-needle techniques would build the business for this typeof equipment.

Core-needle biopsy has not caught on as fast in Europe, particularlyin Scandinavia, where there are many trained cytopathologists,said Hal Kirshner, president of Lorad. That may be changing, however.

"The trend to acceptance of core that we see in the U.S.is happening overseas as well," he said.

Biopsy needle suppliers, the largest being C.R. Bard of MurrayHill, NJ, and Manan Medical Products of Northbrook, IL, have seena continued shift away from FNA to core-needle products, accordingto vendors.

Bard, the first to introduce a biopsy gun for core-needle procedures,has always leaned to the core technique and thus benefited fromthe shift away from FNA, said David Field, marketing manager forBard Radiology.

Manan has also seen a shift in demand from FNA to core-needletechnology, said Wayne Black, a sales manager. One impact on thecompany has been to consolidate sales in fewer of its biopsy products.

"This puts more eggs in one basket," Black said. "

Core is definitely cutting into the FNA market."

New biopsy weapons. While standard core-needle biopsy may beready to vanquish FNA, it has come under attack at the same time.New minimally invasive breast biopsy products from Biopsys ofIrvine, CA, and U.S. Surgical of Norwalk, CT, have reached themarket over the past year. These systems take even larger tissuesamples than core-needle techniques and do not require repeatedinsertions into the breast.

Biopsys, which had a successful initial public stock offeringearlier this month, is marketing the Mammotome Biopsy System,which was cleared by the Food and Drug Administration in April1995, according to the company's IPO prospectus. Biopsys debutedthe unit at last year's Radiological Society of North Americameeting.

The Mammotome reusable drive unit is mounted on a stereotacticbiopsy table and sells for a list price of $7500. A single-useMammotome probe and related disposable components sell for $135.

Biopsys has nonexclusive marketing agreements with both Fischerand Lorad for sale of Mammotome on their biopsy tables. U.S. Surgical'sABBI breast biopsy device is used on a specially designed tablemanufactured by Lorad.

The Mammotome probe is inserted once in the abnormal tissue area.A vacuum draws tissue into the probe and cuts off about a 40-milligramsample, according to the company. The probe then rotates and theprocess is repeated.

Reimbursement of Mammotome procedures is a concern for Biopsys,according to its IPO prospectus. There is no payment code forthis particular procedure, so users must bill with existing biopsycodes.

Both Mammotome and ABBI are targeted exclusively at breast biopsy,noted Bard's Field. This excludes many other soft-tissue areasin which core-needle biopsy is used, such as the prostate, liver,and kidney.

Many users report good results from both traditional core-needlebiopsy guns and the new minimally invasive biopsy systems, saidManan's Black. When this happens, there is less justificationfor the additional expense of both the reusable and disposableparts of the newer systems.

"Why pay $7000 for the unit and $150 a needle when you cando it with a system like a (core-needle) biopsy gun from Bardor Manan for around $15 (for the disposable needle)?" Blacksaid.

Biopsys and U.S. Surgical are targeting their breast biopsy systemsat surgeons rather than interventional radiologists, accordingto Field.

This could be because the minimally invasive techniques willhave a cost advantage when compared with surgical biopsy, he said.Both the surgical and minimally invasive techniques, however,are more expensive than core-needle biopsy.

Whatever the biopsy technique, it is likely that surgeons willbe the physicians performing the procedure in the future, Fieldsaid.

"In the next three years, it (biopsy) is going to be allsurgeon-controlled," Black agreed.