QuidelOrtho: Transforming the Power of Diagnostics
In May of 2022, Quidel Corporation (“Quidel”) and Ortho Clinical Diagnostics Holdings plc (“Ortho”) officially combined to create QuidelOrtho. QuidelOrtho’s point-of-care eye health solutions include InflammaDry® and the QuickVue® Adenoviral conjunctivitis Test. Both are rapid, lateral-flow based, point-of-care products for the detection of infectious diseases and conditions of the eye.
InflammaDry
According to the 2017 TFOS DEWS II Report, dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film. It is accompanied by ocular symptoms in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.1
The lack of correlation between clinical signs and symptoms of dry eye disease makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of dry eye.2
InflammaDry is the first rapid, in-office, CLIA-waived test that detects elevated levels of MMP-9, an inflammatory marker that is consistently elevated in the tears of patients with dry eye disease.
Clinical benefits
- Pre-surgical measurements are more accurate and post-surgical outcomes are improved by identifying and treating patients with dry eye.3
- Post-surgical complications can be reduced by identifying dry eye prior to surgery.1
- Therapeutic treatment of dry eye improves patient quality of life.4
Fast and accurate
- Results are available in as little as ten minutes.
- Provides higher positive and negative agreement compared to other dry eye tests.
Easy and convenient
- Disposable test, requires just four easy steps.
- No additional equipment is needed to administer or interpret.
QuickVue Adenoviral conjunctivitis Test
Acute conjunctivitis—more commonly known as “pink eye”—affects nearly 6.9 million people in the United States every year.5 Approximately one in four patients with acute conjunctivitis have confirmed adenoviral conjunctivitis.6,7 QuickVue Adenoviral conjunctivitis Test is the first and only CLIA-waived, point-of-care test that detects all known serotypes of adenoviral conjunctivitis.
The QuickVue Adenoviral Conjunctivitis Test helps providers:
- Isolate and manage contagious patients
- Prevent the spread of infection
- Reduce unnecessary antibiotic prescriptions
- Reduce potential ocular allergies and toxicities associated with unnecessary antibiotic use
- Support the prevention of antibiotic resistance
Diagnosing inflammatory dry eye with InflammaDry
Dr. Devries is the co-founder of Eyecare Associates of Nevada, established in 1992. He was described by Dr. Dierker as “an essential part of dry eye education throughout the country and internationally” who has extensive knowledge about new technology to help improve patient care. His practice focus is on surgical co-management and treating diseases of the eye.
Dr. Devries said QuidelOrtho’s InflammaDry is “one of the easiest tests to implement in the clinic when it comes to point-of-care testing.”
“InflammaDry measures MMP-9, which is an essential proteolytic enzyme to measure,” Devries explained. “The reason it's so essential is that it's a non-specific inflammatory marker. So, if your patient's eyes are inflamed for any reason, you can detect that with very high sensitivity and specificity by measuring MMP-9.”
In addition, he described QuidelOrtho’s QuickVue Adenoviral Conjunctivitis Test as highly valuable, since it can identify the many different variations of the adenovirus.
How does InflammaDry create value in patient care?
Devries said he’s been using the InflammaDry test since its inception and has found it to be “incredibly valuable” to the practice.
Dierker agreed.
“In my practice, I use a modified SPEED questionnaire for nearly all new patients,” Dierker said. “If they have a sign or symptom, that's going to trigger point-of-care diagnostic testing—including MMP-9 testing with InflammaDry.”
Devries said they also use a SPEED questionnaire.
“It automatically triggers the standing protocol if it's at a certain level, which the provider selects,” he explained. “In my case, that’s six or above, which automatically generates point-of-care testing, including InflammaDry.”
Devries said regardless of the reason for the visit, if the patient scores six or above, InflammaDry testing is done.
“I need to know if there’s inflammation in the eyes,” he explained, emphasizing that for presurgical patients, the presence of inflammation could potentially have a negative impact on surgical outcomes.
Devries added that another benefit of measuring the MMP-9 level is that it provides objective results that can be discussed with the patient to support the rationale for treatment.
“Instead of just saying that we need to optimize the ocular surface, we’re saying that we want to optimize the ocular surface because the patient is showing inflammation as a result of dry eye," he said.
When used broadly for all patients, Devries said InflammaDry helps to identify “non-specific inflammation,” which can then be further assessed to determine the underlying etiology.
“MMP-9 is a matrix metalloproteinase, which is released by stressed epithelial cells,” he explained. “It doesn't matter how you stress those epithelial cells. It may be due to allergic conjunctivitis, a contact lens-related inflammation or infiltrate, or dry eye. So, you have to apply your clinical skills to rule out the other inflammatory events that could cause the MMP-9 to be increased.”
How does InflammaDry help guide the treatment plan?
In his clinic, Devries said a technician performs the SPEED questionnaire, which triggers the point-of-care diagnostics. Noting that the InflammaDry results are provided in a color range of pinks and reds to reflect inflammatory severity, he said if it’s “bright red,” that would indicate the patient has “a considerable amount of inflammation far above the threshold, which would be faint pink.”
In that case, prior to starting treatment, Devries said he would perform a slit-lamp exam, as well as other appropriate tests, to help inform the treatment plan. He then repeats InflammaDry testing when he expects to see “significant changes” based on the timing of results obtained in pivotal clinical trials of the therapeutic.
“I’ll see that patient back when I expect to see results, which may be in two months or so,” Devries explained. “The interesting part is that patients love to have the test and will ask about it. They want to know if their inflammation is improving.”
He said measuring MMP-9 levels also helps to determine when additional treatment modalities should be added.
“For example, once that inflammation is lowered to a point, then we can consider punctal plugs,” he explained. “It also tells us initially if we wouldn’t want to do that. So, initial and ongoing testing helps guide treatment decisions.”
Dierker said they use InflammaDry in a similar way in his practice to help guide the treatment approach.
“If there isn't a lot of inflammation or that MMP-9 is negative, I reassess to determine whether something else is going on besides dry eye,” he explained. “On the flip side of that, if it's bright red and it's definitely a positive test, but the rest of the clinical picture doesn't look like dry eye, I try to determine what else I may be missing. So, I use it in combination with my patient history and exam right out of the gate.”
Devries agreed, saying that when he receives dry eye referrals that don’t turn out to be dry eye, those patients often have epithelial basement membrane dystrophy (EBMD), and InflammaDry testing “really helps bring that out.”
How does InflammaDry support patient engagement?
Noting that there are “no limitations” to performing and repeating the test, Devries said InflammaDry is also a valuable tool for patient engagement.
“I think it’s really important to explain to the patient initially that we’re assessing inflammation, which plays a key role in dry eye,” he said. “By setting the stage in that way, we can connect treatments and progress to the results we’re trying to achieve as measured by InflammaDry testing.”
Dierker said he’s also found it valuable in helping guide conversations with patients.
“Before I ever walk in the room, I can see that the MMP-9 level is lower,” he explained. “When that’s the case, I can walk in with confidence and say, ‘Hey Mrs. Smith, this is great. Our medication is working, your inflammatory markers are much better than the last time I saw you. How have things been going on your end?’ It really changes the conversation dynamic with the patient when you have that additional data point.”
Devries agreed.
“It changes the whole dialogue,” he said. “And you want to be able to control the dialogue.”
Devries added that recent guidelines from the American Society of Cataract and Refractive Surgery (ASCRS) discuss the preoperative use of InflammaDry to measure MMP-9—along with osmolarity—to help identify patients for whom surgery should be delayed until other treatments can be used to optimize the ocular surface.
“In our clinic, I’ve found those guidelines to be helpful to use with pre-op patients,” he said. “It really helps to state the position paper of the ASCRS to explain why we’re doing what we’re doing, which may include holding off on surgery.”
Devries added that doing so can have a positive ripple effect, regardless of the care setting.
“Whether it's the surgical facility or the co-managing facility, we want a better patient experience, tighter outcomes, and the ability to titrate things,” he explained. “The happier we can make patients and the more justification we can give them for the treatment plan, the better.”
How does InflammaDry support practices?
Devries said that from a patient care and revenue standpoint, providers have two options.
“You can either see more patients or you can do more for the patients you treat,” he explained. “If you're doing more for the patients you treat justified by a point-of-care test, then you're raising the level of care you're providing and you're supporting the revenue of the clinic.”
He said that implementing QuidelOrtho’s point-of-care testing solutions in a practice requires no capital investment, other than obtaining a CLIA waiver.
“That’s a state and a federal application you fill out that’s relatively easy in most states,” Devries explained. “Then, it's as simple as buy the test, do the test, bill for the test. And when you're billing for a point-of-care test, it doesn’t affect your evaluation management code. It doesn't affect any other procedures you do. It’s simply billed as a test under a separate set of deductibles for patients. And in the case of Medicare, it's 100 percent covered.”
He added that although some insurers pay more than others, “You're never stuck holding the bag.”
And when an insurance company doesn’t cover it, Devries said they discuss that with the patient and ask them to sign an ABN if they would still like to have the test—which many do.
“It’s shocking how many patients want the test and are willing to pay for it,” he said.
Noting that they rarely have payment issues for the test, Dierker said although “you're not going to retire doing MMP-9 testing, it’s going to be a positive net to your practice.”
“But I think the biggest thing is that it helps you make decisions with more confidence and it benefits patient flow,” he added. “If I don't have that information, I have to try to guess a little more about our next step.”
Devries pointed out that MMP-9 testing also leads to more downstream procedures.
“Because if an anti-inflammatory medication isn’t reducing the levels, then you have to move to the procedures, and it justifies that,” he explained. “So even if it was only a break-even revenue generator, I would still do this every day on every patient because it leads to increased patient confidence. I’m able to tell them that my specific treatment decision is based on a point-of-care test."
