President Joe Biden is seeking more than $2.8 billion from Congress for the “Cancer Moonshot” initiative aiming to cut cancer deaths in half in the next 25 years. The moonshot is not new—it was launched in 2016 by President Barack Obama—and neither does it have a concerted focus on one form of cancer in particular.
Breast cancer is the No. 1 cancer in American women and the second-leading cause of death for the group overall. Femtech investment has been focused on the diagnostic stage of care with new offerings addressing care equity gaining traction. Through the use of emerging technologies, including 3D mammograms and AI-powered diagnostics and pathology, experts hope timely and precise diagnosis may help the industry make a giant leap in the fight against cancer.
Takeoff: Advancing the science of mammograms and genomic tests for all
One of Biden’s main goals in the mission is closing gaps in cancer screenings. A study released this week by OM1 found that women who underwent digital breast tomosynthesis, 3D mammography, had improved screening outcomes as compared to women who received a 2D version of the test.
“We expect the 3D technology to be harvesting cancers that are at an earlier, lower stage,” Jessica Paulus, vice president of research at OM1, told Fierce Healthcare. “All of these analyses are really geared around that big picture question of 'Does it save lives?’ Because there's a lot of breast cancer that is treatable.”
OM1’s retrospective study looked at over 2.5 million mammograms from more than a million women. The study found that 3D mammograms detected 5.3 cancers for every 1,000 screenings compared to 4.5 for 2D images. Biopsy rates for the more advanced test were 17.6 for every 1,000 screened compared to 14.5.
The reason for the significant improvement in detection, Paulus said, is due to the image slices taken with 3D images, visually similar to MRI readings. This methodology allows for dense breast tissue to be more carefully assessed.
Other studies have backed the findings, showing that while upgraded screening devices cost more upfront and payers may charge more for the test, patients are less likely to be called back for suspicious findings and expensive follow-up tests that ultimately turn out to be negative.
As of March 1, the FDA estimates that 55% of mammography systems use this 3D imaging. However, Paulus and OM1 have found that some women are accessing the technology more than others. “Black women get the better technology less,” Paulus said. Black women with breast cancer experience mortality rates 41% higher than their white counterparts.
“It matters a lot about where you live, that's where the access comes in,” she said. “It's not choices that providers or patients are making. It's a matter of structural issues around where the devices are.”
Genomic testing is a similar story. Conventional genomic tests used for breast cancer tumors can be less accurate for Black women, according to a recent JAMA study.
Nathalie Johnson, president of the American Society of Breast Cancer Surgeons, says that common 21 gene scores used to direct treatment plans are not performing equally across racial groups. She advocates for panels that use 100 to 150 genes, like MammaPrint and BluePrint from Agendia. According to a 2021 study published in JAMA, 21 gene panels are undervaluing the threat of cancers in Black women.
“When these women are getting low-risk scores, we think they should do well without the addition of chemotherapy,” Johnson told Fierce Healthcare. “Whereas if they were high risk, we would give them chemotherapy. For some reason, this data is not really being recognized in treatment.”
Johnson thinks that the expansion of more complex panels could lead to better treatment plans. By feeding that information back into machine learning models, precision medicine can take off, saving the lives of millions of women, she said.
Further downstream: AI and breast cancer digital pathology
Ibex Medical Analytics is one of several rocketing AI cancer pathology companies. In January, the Israel-based company announced a collaboration with AstraZeneca and Daiichi Sankyo to develop an AI-based HER2 scoring product. Better scoring of the HER2 protein could improve treatments and outcomes, the company said.
Since then, the company benefited from a 123 million pound sterling investment by the U.K.’s National Health System trusts in AI health solutions. Just last week, Ibex announced a partnership with Alverno Laboratories to bring its suite of AI solutions to labs across Illinois and Indiana in order to increase quality control and decrease turnaround time.
“The best labs have an error rate of 2%,” Yair Heller, Ibex chief operations officer, told Fierce Healthcare. "By an error, I mean something that impacts patient care. The patient might not get the right drug, might get it delayed. At the worst labs, we've seen a 15% error rate, which is insane.”
Ibex’s diagnostic platform, dubbed Galen, was granted breakthrough-device designation by the FDA in 2021, but reimbursement for digital pathology is still spotty. Ibex sees its new partnership with AstraZeneca as a one-way ticket to staking a claim for the technology. “This will be the first step, I think, towards general reimbursement all over the world,” Heller said.
PreciseDx is also in the digital pathology space but slightly more downstream. Once malignancy is confirmed, PreciseDx uses AI to specify cancer grading and risk categorization. In a December study published in Breast Cancer Research, the tech proved its ability to predict early-stage breast cancer recurrence.
Last month, the company announced approval for AI-enabled breast cancer diagnosis from New York state. Due to the state’s diverse population, PreciseDx sees the opportunity to further inform its machine learning algorithms to leave no patient behind.
Like other companies in the area, PreciseDx focuses on other cancers like prostate, but breast is a big focus not only because of its prevalence but also because of the specific challenges it presents.
PreciseDX Chief Medical Officer Michael Donovan, M.D., Ph.D., told Fierce Healthcare that lessons from breast cancer can spread throughout oncology. Both breast and prostate cancers have grading systems that have “come in and out of favor,” Donovan told Fierce Healthcare. Standardizing grading through AI can mean standardizing care.