NEW YORK – More than 12 years after QuidelOrtho — then simply called Quidel — first described the platform, it launched its Savanna rapid molecular diagnostic testing system last month, just before Christmas, after receiving US Food and Drug Administration 510(k) clearance.
With the long-awaited market authorization, the firm now plans to quickly expand the testing menu to spur adoption of the system, which according to QuidelOrtho has novel features that may differentiate it in the decentralized molecular testing space.
The Savanna sample-to-answer molecular system performs true qPCR on multiplex panels with up to 12 targets in approximately 25 minutes using an instrument the size of a toaster, Tamara Ranalli, senior VP of the firm's molecular diagnostics business unit, said in a recent interview, adding that the system comes with a novel function called Test Select.
This option enables users to mask results on a multiplex panel and only report on targets the ordering clinician requested. The system then allows up to 48 hours to unmask additional results, should a clinician require further testing. This feature, which is the result of extensive consultations with laboratories, Ranalli said, helps users avoid the potential angst of knowing a patient is positive for a panel target that wasn't ordered and can possibly increase reimbursement options for labs with no additional cost or sample collection required.
"It puts a lot of control in the hands of a clinician or a laboratory in how they do their diagnostic testing, rather than the manufacturer making those decisions," Ranalli said.
QuidelOrtho obtained 510(k) clearance from the FDA for the Savanna system along with a herpes virus panel that detects and differentiates HSV-1, HSV-2, and varicella-zoster virus (VZV) nucleic acids obtained from lesion specimens.
The firm took its first US Savanna customer orders the day after the clearance and has already shipped instruments to US customers, QuidelOrtho CEO Doug Bryant said last week at the 42nd JP Morgan Healthcare Conference in San Francisco.
The San Diego-based company previously built an instrument inventory in anticipation of US regulatory clearance, he said, adding that "even though HSV is a smaller market, it's what we call a gatekeeper assay — it enables us to get in the door and to place analyzers quickly."
QuidelOrtho obtained the CE mark for Savanna in 2021 along with a test called RVP4 that detects influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2. The firm submitted the instrument and RVP4 to the FDA in 2022 for Emergency Use Authorization, but supply chain constraints soon led it to focus on supporting Savanna sales in Europe. In August 2023, QuidelOrtho said that it also submitted the system for 510(k) along with the HSV/VZV panel.
Now, "as soon as RVP4 is cleared, we expect that to dramatically accelerate the placement rate," Bryant said at JP Morgan.
To illustrate the anticipated rate of expansion, Bryant said an unnamed urgent care system recently ordered Savanna instruments for HSV/VZV testing at two of its sites. "It's clearly not a test that needs to be done at all 67 of their sites, but you can imagine that I'll be shipping 65 more shortly," he said, adding that he anticipates that RVP4 will be cleared later this year.
QuidelOrtho originally got de novo clearance for its HSV 1+2/VZV assay under its Lyra brand of PCR kits in 2014, followed by 510(k) clearance for the HSV 1+2/VZV assay on its Solana isothermal nucleic acid amplification system in 2016.
While other developers now make similar test kits and assays for their laboratory instruments, QuidelOrtho is the only provider of this type of panel for decentralized test solutions, Ranalli said. Having a rapid combined test for these pathogens has advantages for customers, she noted.
Specifically, while HSV-1 and HSV-2 were once thought to colonize distinct parts of the body, that's now known not to be the case. Distinguishing between the two types can be helpful to differentiate primary and recurrent infections and for prognosis, as genital HSV-1 is less likely than HSV-2 to recur in the first year after infection.
And while varicella-zoster virus, also known as HSV-3, typically causes chickenpox in children and young adults, in approximately one-third of cases, the infection reactivates later in life in the form of shingles, a painful blistering condition that can persist for weeks. There has been an increase in shingles cases over the past few decades, with some research suggesting that SARS-CoV-2 infection can have a rare side effect of reactivating a dormant VZV infection.
Although the location and number of blisters often differs among the three infections, it isn't always clear-cut, especially for people who are immunocompromised. All three infections can be treated with similar antiviral medications, but the dose needed for shingles infections is significantly higher.
As Bryant disclosed on QuidelOrtho's third quarter call with investors, the next innovation will be the addition of a syphilis target to the herpes panel.
As recently reported, syphilis infections in adults as well as those transmitted from mothers to infants during childbirth have surged in recent years, in part due to impacts of the pandemic on healthcare. Syphilis lesions, called chancres, can resemble herpes lesions, so having a rapid molecular test to tell them apart could help curb the current epidemic.
Ranalli said that this panel will require de novo FDA review, but "we think the first comprehensive lesion panel to include molecular detection of primary syphilis is going to be a revolutionary testing option, particularly for decentralized testing."
QuidelOrtho presented data at the most recent Clinical Virology Symposium for the HSV/VZV panel with the addition of a target detecting nucleic acids of syphilis-causing Treponema pallidum bacteria. The company evaluated 88 clinical samples using the Savanna HSV 1+2/VZV/TP panel and found high overall percent agreement with its cleared Solana test for the HSV/VZV targets and with two real-time PCR kits to detect T. pallidum.
Ranalli said that the future menu may also include a comprehensive molecular pharyngitis panel that includes standard group A Streptococcus targets as well groups C and G strep, Fusobacterium, and Arcanobacterium targets.
QuidelOrtho's R&D team is also currently working on two gastrointestinal panels for Savanna — one for viruses and bacteria that includes 12 targets, and one for parasites — as well as a sexually transmitted infections panel that detects and distinguishes gonorrhea, chlamydia, Mycoplasma genitalium, and trichomonas.
And the firm is planning a more comprehensive respiratory panel, currently dubbed RVPX, Ranalli said. This test will be applicable to inpatient hospital and pediatric testing, but also can be used for testing in an emergency department to determine if a patient should be hospitalized, she said.
Savanna was first described in 2010 as a development project in collaboration with researchers at Northwestern University and the NU Global Health Foundation.
The program, initially dubbed Project Wildcat, was awarded $8.3 million from the Bill and Melinda Gates Foundation in 2013 to support the development of rapid point-of-care HIV testing for use in low-resource settings.
A prototype instrument was unveiled in 2014, but the system was subsequently revamped over the ensuing years, with features such as a smaller footprint and expanded multiplexing capabilities, positioning it for decentralized point-of-care use.
The earlier versions of the system also included the option to run assays using qPCR or helicase-dependent amplification (HDA). Advances in thermal cycler technology and PCR chemistries have allowed standard PCR to become almost as fast as isothermal reactions, Ranalli said, so while the Savanna instrument can still potentially run isothermal tests, for now the firm is only developing qPCR Savanna panels.
One of the first times Savanna's multiplex panels were described was at a 2018 investor presentation, with Bryant laying out an assay pipeline for the system that included small syndromic panels for GI pathogens, sexually transmitted infections, respiratory viruses, pharyngitis, and vaginitis, as well as assays for HIV and methicillin-resistant Staphylococcus aureus.
QuidelOrtho now expects to tap into a roughly $3 billion addressable market with Savanna, with Bryant noting at the JP Morgan conference that the firm has a revenue goal of more than $250 million for the system in the three years following the US launch.
As head of MDx, Ranalli said that instruments and assays must align with the firm's goals of providing insights to individuals, families, and communities, so they can spot trends sooner and respond quickly and confidently. "Sometimes that's with novel platforms, and sometimes that's with novel assays," she said.
Going forward, the Savanna platform remains at the forefront of QuidelOrtho's MDx business, Ranalli said, as it continues to evolve its near-patient PCR testing solutions.