While the prospect of a cancer diagnosis remains scary, the strides researchers have made in early detection can reduce the anxiety associated with the disease. But those advances do no good unless individuals avail themselves of them.

Chris Beddard is at the forefront of the fight against cervical cancer. Beddard is the head of core molecular diagnostics and women’s health and cancer at BD integrated diagnostic solutions, which has developed a new screening mechanism that holds out the promise of vastly improved outcomes. As long as women use it.

During the pandemic, screening declined for obvious reasons. But it’s now time to get back to the business of keeping cancer at bay. NJBIZ recently spoke with Beddard about BD’s new test and the importance of early detection.

“It’s similar to other stories, but the most important thing is again to get out there and get screened for the potential or the risk of developing cervical cancer,” she said. “It is preventable and it’s really about determining the risk early on.”

What follows is an abridged version of that conversation. The questions and answers have been edited for length and clarity. A video of full interview is available at NJBIZ.com/njbizconversations.

NJBIZ: Tell me a little bit about what you do at BD.

Chris Beddard: So my role is a global function, where we focus on core molecular testing, which is a lot of the tests that you’re hearing about these days certainly around coded sexually transmitted infections — obviously HPV — as well as our women’s health and cancer portfolio, which is a cytology or cell-based review of samples that Is utilized around the world. Many of these laboratories require high volume systems and have high volume testing, so that’s my primary focus for the global role in the portfolio that we’ve provided at BD.

Q: Now I wanted to talk to you today because I understand that you have a fairly exciting development in the area of cervical cancer. First let’s talk a little bit about that disease. My understanding is that it’s pretty frightening. What do we need to know about cervical cancer; how prevalent is it and what do women need to know about it?

A: The good news is that our rates are on the decline. At one time it was one of the most common causes of death for American women, but we are certainly seeing an improvement to the rates of cervical cancer, and also death. Estimates from the American Cancer Society indicate that about 14,000 new cases will be diagnosed in 2022 resulting in a little over 4,000 deaths of American women. But really the sad part is that it’s preventable, or potentially preventable by use of a vaccine, but also with regular screening to identify the risk of a woman developing cancer or even pre-cancer of the cervix. So, in other words, we can stop cervical cancer before it becomes invasive and potentially too late. That’s the good news.

I think the reason these rates are declining is that there’s been such a heavy focus on cervical cancer screening initially using something called the Pap test, which looks at abnormal cells of the cervix. But, more recently, something called an HPV test or human papillomavirus test is also available.

The HPV virus is one of those commonly sexually transmitted viruses. It’s estimated by the CDC that in 2021 about 79 million Americans would have HPV. But, again, the good news is not all of these types of HPV are related to cancer. Today, about 14 are related to cancer and, again, there is a test now that looks at these 14 high risk types of HPV and is able to give a result as it relates to determining that a patient potentially has these 14 high risk types of the virus. Obviously, there are many solutions and the focus now on HIV testing provides additional value to women around the U.S. and also globally for sure.

Q: So the test we wanted to talk about today — this new test, the Onclarity HPV Assay — what is that, and how does it work?

A: The BD Onclarity HPV Assay is basically a molecular test that’s performed in a laboratory and detects those 14 higher risk HPV genotypes. For the [readers] a genotype is the genetic constitution of the organism, or in this case HPV. That’s kind of its mark or how we refer to the different types of HPV based on their geno-types.

So the good news about the BD Onclarity HPV Assay test is that it detects all 14. But it also individually reports out six of these high risk genotypes and then groups the other eight in three groups. So it provides a lot of information for the clinician to determine what type of patient management is required, based on the risk level of the genotype.

So just as a note, the prevalence or percentage of high-risk genotypes, the number, if you will, varies, based on population as well as geography. So the U.S. is different than other parts of the world. And certainly the populations would have different compositions of genotype prevalence.

Q: You mentioned what it does for doctors. Can you tell me a little bit more about the benefits for clinicians? What do they get from this test that they don’t from others?

A: So the six individually reported genotypes include the most commonly recognized, type 16 and 18, that would require immediate attention and again, there’s patient management. We also report individually HPV 31, which poses a high risk, or higher risk for development of pre-cancer, than 18. So we are the only HPV essay that’s FDA-approved today that does this. And again, more information provides better clinical management of patients.

Additionally, we know that monitoring these genotypes for something called persistence, that we’re seeing the same genotype, in the same patient, year after year, is also a key identifier in the risk of pre-cancer or developing cervical cancer. So again, the more information that we provide the clinician really helps how they’re going to measure a woman’s risk for developing this type of cancer. So it’s important to give as much information as possible to help the patient.

Q: And that was the next question. What does it mean for patients that this is now available?

A: Again, it goes back to the detail of the high-risk genotypes for HPV — that we provide those six individuals. But also monitoring the persistence. It’s really about helping women understand that they’re at risk and what’s the next step if they are at risk for developing cervical cancer. More information is powerful as we all know.

Q: Right. Now, I think you said that this has already been approved by the FDA. Did I hear that correctly?

A: Yes, we are approved by the FDA. We have claims for something called HPV primary testing, which is using HPV test primary for the screen, something called co-testing where you use HPV testing, as well as the cytology testing. And then a third testing paradigm called cytology reflex or positive cytology abnormal cells reflex HPV. So for all three testing paradigms we are, we are approved by the FDA.

Q: The question then is this available to women who are interested in getting this test? What do they need to do? Who should be most interested in getting these kinds of tests?

A: As recently as 2020 guidelines for screening by the American Cancer Society were updated and today the guidelines state that, from the age of 25 through the age of 65, women should be screened for cervical cancer. The recommendation from the American Cancer Society is the use of the HPV every five years, and this is preferred today. Co-test is acceptable at every five years, as well as that Pap test or cytology alone test, is acceptable every three years. But again, the preference from the American Cancer Society is to be screened every five years, with HPV from the age of 25 to 65.

Q: And you did mention that the prevalence of cervical cancer varies among groups, among geographies. Are there groups and are there areas that are more susceptible and that are more vulnerable?

A: Well, again, we know that the women that are more vulnerable are the ones that are not getting screened or are not getting screened within that five-year timeframe. So that’s a large contributor to the cervical cancer screening rates.

I think something that we’re also very aware of, based on the COVID pandemic, is that screening declined. In fact, there was an article that was just published ahead of print yesterday from the American Cancer Society Journal that shows a screening deficit of about 69% based on pre-pandemic levels. So, we know that there’s a need to continue to focus on getting the message out, the urgency of routine screening, and again that this is preventable.

The way we prevent it is making sure that we’re being screened within those intervals that the American Cancer Society is recommending and the fact that we can do something with the information that we’re providing.

If women want to learn more about our assay, it’s the BD Onclarity HPV Assay and we provide something called extended genotyping. That’s the description of those 14 high-risk genotypes, the six that are reported out individually and the other eight that are in three groups.

We also have a great website … just Google our Onclarity HPV Assay or go to womens-health-solutions.BD.com and you can learn more about the product as well.