Tissue Reagents Breast Pathology

Breast Pathology

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Deliver diagnostic confidence

Only from Roche, VENTANA breast cancer diagnostics deliver on three key benefits pathology professionals value: clinical superiority, analytical superiority, and testing efficiency.


See more of what matters with the INFORM HER2 Dual ISH DNA Probe Cocktail assay

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Real Patient Stories

We’ve told you how we do it. Now we’ll show you why.

> Read patient stories

Disease State Diagnostic Toolkit: Breast Cancer Diagnostics

15–20% of breast cancer patients overexpress the HER2 protein & are eligible for treatment with highly effective HER2-targeted personalized therapies that improve outcomes.

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Featured breast cancer assays

CONFIRM ER (SP1) Rabbit Monoclonal Primary Antibody

  • FDA cleared antibody
  • Indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer.6
  • ER (SP1) is a significant predictor of disease-specific survival.7,8
  • Rapid and consistent results delivered through fully automated platforms and digital pathology solutions

INFORM HER2 Dual ISH DNA Probe Cocktail assay

  • FDA-approved test
  • Convenient brightfield detection technology to perform a comprehensive analysis of tissue on the slide, and evaluate HER2 gene status with morphological context
  • Identify intratumoral heterogeneity
  • Greatly reduced time to result with full automation
  • Run the test in-house instead of sending it out

PATHWAY HER2 (4B5) Rabbit Monoclonal Primary Antibody

  • FDA-approved antibody
  • Higher overall proficiency assessment scores with HER2 (4B5) than with any other clones
  • Widely adopted and reliable HER2 IHC primary antibody7
  • High concordance with HER2 ISH4

CONFIRM PR (1E2) Rabbit Monoclonal Primary Antibody

  • FDA cleared antibodies
  • Indicated as an aid in patient management, prognosis, and the prediction of therapy outcomes in breast cancer9
  • Provide significant value as a prognostic factor and response prediction of hormone therapy, even in ER negative patients10
  • Rapid and consistent results through fully automated platforms and digital pathology solutions


  • Aids in assessing the proliferative activity of normal and neoplastic cells
  • Monoclonal antibody demonstrates increased sensitivity and strong specificity compared with mouse monoclonal antibodies
  • Intense nuclear staining and no adipose (K2) or cell membrane staining can help deliver a confident assessment of tumor aggressiveness.

See more of what matters with the
INFORM HER2 Dual ISH DNA Probe Cocktail assay

Bring the power of brightfield ISH testing to your lab

Use all we’ve learned about automated
in situ testing to benefit your practice and the patients who count on your work

  • Results are easily scored using brightfield microscopy — in-house with familiar technologies
  • HER2 gene amplification assessment over the entire slide — not just a pre-selected area — facilitates scoring and identification of heterogeneity
  • Simultaneous morphological assessment independent of H&E stain
  • Archivable results allow for easy maintenance and simplifies consults in difficult cases
  • Enhanced technical support tools — including clear, consolidated guidance on best practices and streamlined training

Let’s build confidence together

Breast Cancer Patient Stories

Learn more about how we deliver diagnostic confidence to breast cancer patients everywhere.

Nicole’s story

Finding a new normal after breast cancer

When Nicole turned 40, her best friend urged her to get her first mammogram.

“You’re the best mom I know — you’ll do anything for your kids,” said her friend, who had lost his mom to breast cancer years before. “Do this for your kids.”

She made an appointment, had the test and a few days later got the call.

Nicole, a single mom, had breast cancer. It had spread to two lymph nodes and invaded her chest wall.

“It was like I got hit by a truck,” Nicole recalled. “I was in a daze. I couldn’t even cry.”

The diagnosis was terrifying. But Nicole had two fabulous reasons to fight.

“I fought cancer for my kids,” said Nicole, now 43. “Honestly, they are the only reason I believed I could beat it when things got really tough. They make me strong.”

The journey that started a week before Christmas 2013 has had many challenges — including changing doctors just before surgery. “But I believe it was meant to be,” Nicole said of finding the right doctor, getting the right diagnosis and receiving the right treatment.

Life after treatment

Now in remission for two years, Nicole is learning to navigate this new life.

“You really aren’t prepared to be a cancer patient for life,” Nicole said. “I thought once I beat cancer I would go back to normal, I’d be myself again. On my last day of radiation I was so happy that I was going to get back to normal. But my doctor told me I’d have to find a new normal. I said, ‘no, I’m done with cancer. I beat it.’ But she told me that I would always be a cancer patient. And she was right.”

At the center of this new normal are Nicole’s children — Kayla, 15, and Xavier, 14. The two have been there for their mom through it all, helping to run the house when Nicole was on bed rest after surgery and during her eight weeks of radiation, which left her exhausted.

In this new life after treatment, there are hikes in the mountains, bowling with the kids, trips to the movie theater and game nights at home. She is strong for her children, but anxiety lingers, as she works to find her new normal.

“I’m very thankful that I’m here, but the worry that it will come back is still there,” she said.

Reaching out for support

Nicole finds peace and camaraderie at a support group for cancer survivors. She found a group for younger women like her, many of them moms. It helps to tell her story, and listen to the stories of others, finding common ground.

“You are now part of a group you didn’t ask to be in — with some of the most courageous, stubborn, beautiful people you will ever meet,” Nicole said.

She has learned that everyone’s cancer journey is unique. “My doctor told me he could put me in a room with 500 women who have breast cancer, and there are 500 different journeys. That always stuck with me. I took what people told me or what I read on the internet with a grain of salt because my journey was going to be different.”

Through it all, she has learned to advocate for herself, and spreads that message to other cancer warriors.

“For surgeons, this may be their hundredth breast cancer surgery, but this is my first. I’m not just a file. Be your own advocate. Ask questions, It’s your body.”

Erin’s story

Young pathologist survives breast cancer — with her sense of humor intact

Erin, a vivacious, green-eyed 40-something was on her way to the top. She was a pathologist — a doctor who diagnoses cancer and helps to guide patient therapy — and she had applied for a new position at Roche Tissue Diagnostics, a leading cancer diagnostics company. She got the job. She got the low-down on the local team’s purpose: to improve the lives of all patients afflicted with cancer. And she got her annual mammogram.

Erin’s mammogram said she did not have any invasive tumors.

She did.

She wished her tumor was benign.

It wasn’t.

She told herself she would still feel sexy lugging a clumsy, clanging IV pole down the hall at the cancer center.

She didn’t.

Analytical by nature, Erin carefully examined every step in her cancer journey — but she was confident in three things: the power of laughter, the evolving practice of medicine, and the advanced diagnosis and personalized treatment plan that gave her a fighting chance.

Instead of “Why me,” ask “What’s next?”

“I never stopped to ask, ‘why me?’” Erin said in a recent interview. “I asked, ‘what’s next?’ The fact is, women don’t bring breast cancer on themselves. Yes, we should live responsibly; we should actively care for our health. But most breast cancer comes down to genetics, biological breakdowns and — sometimes — just plain bad luck.” Any woman can get breast cancer. But every woman can fight it, too — and the majority beat it. We have to put our best energy in the path forward: precise diagnostics and well-targeted therapies.

Know your breasts — and the tests

Breast cancer is not one-size-fits all — it is many complex diseases. Knowing your enemy is the first step toward defeating it, and Erin was determined to understand absolutely everything about her cancer. High quality VENTANA BenchMark breast cancer tests revealed Erin’s diagnosis: triple-positive (ER+, PR+, HER2+) breast cancer — and this meant that her therapy would include a multi-faceted treatment plan. The plan was elegant, but it wasn’t easy.

Erin refused to surrender to cancer, but she surrendered confidently to her care — three surgeries, chemotherapy, radiation, and treatment with three different drugs, each custom fit to her unique biology. “Targeted” breast cancer therapies target a woman’s specific cancer with precision and — because they are specially designed to match the patient’s unique biology, they often improve outcomes.

“The hardest part was the wait between surgeries,” Erin admitted. “I wanted to spend less time waiting for answers and more time fighting my disease.” Fortunately, her tests were delivered quickly and provided the level of diagnostic insight her oncologist needed to confidently direct her therapy. For more reasons than she could have imagined when she interviewed, Erin was thankful to work at Roche during her battle with cancer. Access to technologies that boosted her confidence — and benefits that included consultations with independent breast experts — made all the difference.

“In many ways,” Erin said, “I really feel that Roche saved my life.”

Endorphins, employment & inspiration

After a fight that lasted a year and a half, Erin wears only two signs of her battle with breast cancer: a tiny scar near her collarbone where her port was recently removed — and a big, mischievous smile. “I kept my sense of humor too,” she added, “and that kept me going.” She looks amazing — healthy and happy — and we told her so. “That’s another funny thing about surviving cancer,” she said. “Suddenly, everyone tells you how great you look.”

Back at work, Erin pushes her hair out of her eyes and peers into her microscope, reviewing hundreds of pathology slides a week — and she takes cancer personally. She is determined to help as many women as possible do what she has done: learn the facts about her unique biology and breast cancer type — and find confidence in the right diagnosis and therapy. As a doctor, and a survivor, Erin knows that we can turn the tide in cancer.

Strength in numbers

In the US, cancer death rates have dropped 23% since 1991, due in part to improving diagnostics. This translates to 1.7 million lives saved from 1991-2012.1 Next time this data is taken, Erin will be one of the survivors counted among thousands of strong women and men: living proof that we are making progress.

Her message? Laughing is much healthier than worrying. Better breast cancer testing is the first step in better care, and better outcomes. Ask a lot of questions — because in breast cancer, knowledge is power. Don’t take yourself too seriously — though if you work in the cancer field, take your work very seriously — it changes lives.

1 “Cancer Death Rate Continues Steady Drop.” American Cancer Society. Cancer.org. 7 Jan. 2016

Lisa’s story

2,444 days after diagnosis: A joyous journey for breast cancer survivor Lisa Wolfe

What can testing and targeted treatment mean for a breast cancer patient?

For survivor Lisa Wolfe, it means seeing her baby granddaughter come into the world. It means celebrating the upcoming high school graduation of her two youngest children and spending her days with the love of her life, her husband, Stephen.

“Life is awesome,” says Lisa, a six-year breast cancer survivor. “I have a beautiful granddaughter. My business has taken off. And I am still alive. That’s the best thing ever.”

Lisa, 45, was diagnosed with HER2-positive invasive breast cancer when she was just 39. Biomarker testing identified her as a candidate for targeted treatment.

The journey was long and difficult, but Lisa has found joy on the other side, thanks to the right diagnosis and treatment coupled with her own resilient spirit, strength and humor.

These days, Lisa’s 10-month-old granddaughter, Cooper, breaks into a toothy grin at the sight of her grandma. The two dance around the family’s kitchen, and splash in the backyard pool.

“It makes me cry, being with Cooper,” Lisa says. “I really didn’t think I would live to see a grandbaby.” During the darkest days, when chemotherapy, radiation and surgery left her exhausted and the future was uncertain, Lisa managed to keep her sense of humor, setting the tone for the family. They survived, grounded in love.

“At the time of my diagnosis my children were 11, 12 and 18 years of age,” Lisa said. “I’ve always been a straight-forward person with a strong sense of humor. So I wanted to keep the tone light. I told them this is a treatable diagnosis, and we would take it one day at a time. And that’s truly what we have done — 2,444 days later and counting.”

“She’s a conqueror,” says Lisa’s daughter Ashley, 25. “I just love my mom. I’m so glad she’s here. I can’t imagine my life without her.”

Lisa is her happiest surrounded by her growing family, with Cooper and Ashley’s husband, Blake, joining this spirited bunch. “The family table gets bigger and bigger,” she says.

Lisa’s cancer journey has impacted the lives of these three generations of resilient women. Ashley and her sister, Amanda, 17, urge their friends to do monthly breast exams.

“I talk about breast cancer to anyone who will listen,” Ashley says. “Get checked.”

Lisa, who owns a busy pet care business and works alongside her children, looks to the future. She’s excited to see what’s next for Amanda and her son Aaron, 18, who graduate from high school this year.

She’s thankful for good health, and shares a message of hope.

“You can overcome this. You can survive.”

Learn more about how Roche Tissue Diagnostics
helps strong women everywhere fight cancer


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