Micro-array test (Mammaprint)

The researchers looked at 651 women with early-stage breast cancer that had not spread to lymph nodes and whose growth was affected by the hormone estrogen -- a situation that applies to nearly half of all cases diagnosed in the United States. Currently, chemotherapy is recommended for nearly all such women.

de Micro-arra tecniek zal kunnen gaan voorspellen of je een goed of sleht profiel hebt aan genen. Bij een slecht profiel heb je 5 keer zoveel kans op uitzaaiingen. Ook zal er voorspelt kunnen gaan worden of medicijnen zoals tamoxifen aan zal slaan, en zelfs of er uitzaaiingen zullen gaan optreden in de botten en longen.
Het is in Nederland alleen nog in studieverband in gebruik. Wel veelbelovend dus maar het is de vraag wanneer en of BK-patienten hiervan kunnen gaan profiteren.

- de micro-array's test kan tumorweefsel onderzoeken wat ingevroren is. (nog niet op parrafine (soort hars/kaarsvetachtig spul) bewaard weefsel. Tip voor nieuwe patienten is dus om te vragen aan de behandelend arts of er een stukje tumor ingevroren kan worden. (buiten dat het op paraffine gezet wordt, want dat gebeurt meestal omdat het dan goed onderzoekbaar is)

MammaPrint is genetisch test die gebruik maakt van een zogeheten genexpressie profiel om het risico op uitzaaiingen te bepalen in borstkankerpatiënten. Agendia is het eerste bedrijf ter wereld dat ISO certificering toegekend heeft gekregen voor een diagnostische test gebaseerd op microarray-technologie. ISO17025 is een internationale kwaliteitsstandaard voor testlaboratoria en is de meest strikte tot dusver.

Deze ISO certificering is geldig voor een periode van vier jaar, waarin de Nederlandse Accreditatie Raad wel jaarlijks inspecties uitvoert in de Agendia laboratoria om te controleren of het bedrijf nog steeds aan alle vereiste ISO criteria voldoet.

Over MammaPrint
De MammaPrint genetische test maakt gebruikt van een genexpressie profiel bestaande uit 70 genen die van belang zijn voor het gedrag van een tumor. De uitslag van MammaPrint geeft aan of de patiënt een ‘laag’ of een ‘hoog’ risico loopt op uitzaaiingen binnen een periode van tien jaar. Dit is belangrijke informatie voor artsen en patiënten bij het vaststellen van de vervolgbehandeling. In veel gevallen krijgen borstkankerpatiënten na de operatie chemotherapie en/of hormoontherapie voorgeschreven om het risico op uitzaaiingen te verminderen. Verschillende studies in vooraanstaande instituten en ziekenhuizen in Europa en de VS hebben aangetoond dat MammaPrint beter in staat is het risico op uitzaaiingen te voorspellen dan de conventionele methoden, zoals de veel gebruikte St. Gallen criteria. Het blijkt dat MammaPrint zeer accuraat patiënten identificeert die een hoog risico lopen op uitzaaiingen, terwijl deze door de klassieke criteria in de ‘laag risico’ groep ingedeeld waren. Tegelijkertijd is MammaPrint in staat betrouwbaar de patiënten aan te wijzen die een laag risico lopen en die daarom wellicht de zware bijwerkingen van een chemokuur bespaard kunnen blijven.

Test To Predict Breast Cancer Relapse Risk Is Approved

posted: 02/07/07

THE NEW YORK TIMES, 02/07/2007

By Andrew Pollack

A new genetic test that tries to predict whether a woman with breast cancer will have a relapse won approval yesterday from the Food and Drug Administration, marking a step toward an era in which medical treatments are personalized for each patient.

The approval was the first ever of such a complex genetic test, not only the first for breast cancer relapse.

While other breast cancer recurrence predictive tests are being sold or developed, the new one, called MammaPrint, is the first to go through the formal F.D.A. approval process. The agency has signaled its intention to oversee more closely a profusion of sophisticated diagnostic tests that until now have often been marketed without its blessing.

The test is not totally accurate. ''You can't go all the way to the bank with this information,'' said Dr. Steven Gutman, the F.D.A. official in charge of diagnostic tests, in a conference call with reporters. Still, he said, ''I think it's a fabulous tool and one that needs further study.''

MammaPrint, developed by scientists in the Netherlands, examines the pattern of activity of 70 specific genes in a breast tumor after it is removed by surgery.

Dr. Gutman said that 23 percent of women deemed by this genetic signature to be at high risk actually had a recurrence of cancer somewhere in the body within five years. Only about 5 percent of those with a favorable genetic signature had a return of cancer in that time, he said.

Agendia, a company based in Amsterdam that already offers the test in its own country and some others, is considering how to make the test available to Americans, its chief executive, Bernhard Sixt, said in an interview. He would not say how much the test would cost.

MammaPrint and other tests like it seek to help guide the treatment of roughly 100,000 American women each year who have early stage breast cancer that has not spread to lymph nodes.

After their tumors are removed, many of these women undergo chemotherapy to lower the chances that the cancer will return. But studies have shown that most of them would not have a recurrence even without chemotherapy. The new tests could help doctors and patients decide whether some women might avoid chemotherapy and its side effects.

''Everyone is looking for ways to figure out who needs and who doesn't need chemotherapy,'' said Dr. Clifford A. Hudis, chief of the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York. ''This allows us to use the tumor to tailor therapy for individual patients.''

Dr. Hudis is an adviser to Genomic Health, a California company that sells a similar test called Oncotype DX. Genomic Health operates under federal rules that allow tests developed by and performed in a single laboratory -- as opposed to test kits that are widely sold to hospital labs and doctors' offices -- to be offered without F.D.A. approval. These tests are called ''home brew'' tests.

But the F.D.A. said in September that it intended to require approval for certain particularly complex home brew tests -- those that examine multiple genes or proteins and use an algorithm to compute a result. It has sent letters to certain companies, including Genomic Health, saying they may need F.D.A. approval.

The agency will hold a public hearing tomorrow about its proposals. Some test developers and clinical laboratories say they are concerned stricter regulation could slow the development or improvement of tests.

The labs are now regulated by the federal Medicare agency under the Clinical Laboratory Improvement Amendments of 1988.

But Dr. Sixt, of Agendia, said that gaining the F.D.A. imprimatur could help the tests establish credibility. ''I believe the industry in total will gain a lot of speed and clinical acceptance for such tests,'' he said.

The Agendia test could provide some competition to Oncotype DX, the Genomic Health test. The Oncotype test, which costs about $3,500, has been used for more than 21,000 patients over the last three years. Last year, the company performed more than 14,500 tests, double the level in 2005. Big insurers are starting to pay for the test.

Randy Scott, chief executive of Genomic Health, said yesterday that he was encouraged by the approval of Agendia's test because it removed some uncertainty over the F.D.A.'s stance. ''Through this approval they've indicated this is a field they'll be broadly supportive of,'' Mr. Scott said. He would not discuss his company's progress with the agency.

Scientists at the University of North Carolina and the Netherlands Cancer Institute tested 295 tumor samples using both the Genomic Health and Agendia tests. Although the tests examine different genes, they were in accordance about the risk of recurrence about 80 percent of the time, the scientists reported in August in The New England Journal of Medicine.
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