NEW YORK ─ With new platforms in its pipeline, Accelerate Diagnostics expects to triple the size of the addressable market for its rapid bacterial identification and antimicrobial susceptibility (ID AST) testing products to about $3 billion in the next three years from $1 billion currently.
In 2021, the firm plans to deploy two new testing platforms, PhenoAST and PhenoPrep, and late in 2023 to begin marketing a next-generation ID/AST system that includes not only blood, but also isolates, urine, and other specimens as a basis for testing patients with infectious diseases.
Accelerate is currently finalizing its global regulatory strategy for PhenoPrep and discussing a 510(k) submission with the US Food and Drug Administration for PhenoAST, the firm's Chief Strategy Officer John Meduri said in an interview.
With the new products, it intends to launch later this year, the firm expects to target "those customers that have a microbe identification method but want the added value of a rapid susceptibility result to help get patients on the optimal therapy as quickly as possible," Meduri said.
The company expects that laboratories already using a MALDI-TOF MS system or molecular diagnostic system for microbe identification will port results to PhenoAST for antimicrobial resistance testing.
In the US alone, about 50 percent of the microbiology laboratories have a MALDI-TOF system for microbial identification and about 40 percent of them have molecular systems for that purpose, Meduri said.
Meanwhile, with PhenoPrep, Accelerate expects to target laboratories that have already implemented MALDI-TOF platforms for identification but would benefit from having an automated sample preparation system to speed up the process of pathogen identification, Meduri said.
PhenoPrep, a new blood sample preparation system, has been designed to speed up MALDI-TOF identification to less than two hours following a positive blood culture, and enable AST results within about eight hours versus up to 48 hours for a traditional AST system combined with a MALDI-TOF identification system. A lab, in this case, would still use PhenoAST for antimicrobial susceptibility testing after the microbe has been identified following a positive blood culture.
"PhenoPrep removes manual steps required in traditional sample preparation to make this a sample-in, answer-out workflow, and provides a consistent sample to put onto the MALDI-TOF platform and PhenoAST," Meduri said.
For PhenoAST and PhenoPrep, Accelerate expects to target laboratories with MALDI-TOF and molecular systems in the US, Europe, and Asia. By targeting customers with differing test equipment needs, its two new products will help it increase its market share and complement, rather than compete, with its current blood-based Pheno system and PhenoTest BC kit, the firm said.
In its longer-term pipeline, Accelerate intends to introduce a next-generation platform, Pheno 2.0, toward the end of 2023. The system is being designed to enable the firm to enter a higher-volume segment of the ID/AST market by working with different types of samples, including blood, urine, and isolates.
The company doesn't disclose pricing for its current ID AST system and tests, in part because prices are linked to kit usage. However, in a recent presentation, it noted that it is aiming to make available its Pheno 2.0 instrument at one-tenth the size and cost of its current instrument and targeting a price per test that is also one-tenth the price of its current test.
With the next-generation system, Accelerate will seek to provide its products "to many more clinical laboratories around the world," Meduri said. "Pheno 2.0 will provide the same level of accuracy for rapid susceptibility testing that we are seeing with the current system. If a lab wants to run one sample on demand or 100 tests during a shift, they will be able to do that. It's a modular system that will enable labs to build additional capacity as needed."
The turnaround time of Accelerate's current system and kit in providing rapid identification and susceptibility testing for bloodstream infections is central to its sales proposition to hospitals.
In most cases, to identify microbes that cause infections and determine how they will respond to therapy, labs currently have to culture the sample. The process can take eight hours or more before a blood culture bottle comes up positive and a laboratorian can then run a test to identify the disease-causing pathogen. With the pathogen identified, the lab is then able to run an AST test to determine how well the bug will respond to a given therapy.
The entire process can take days to complete using traditional ID AST equipment, but for critical infections such as sepsis, when every hour can be critical for a patient's survival, clinicians want a faster response.
Time to implementation
Accelerate's Pheno system and PhenoTest BC kit, which obtained FDA clearance in 2017 and provides an ID and AST result for bloodstream infections in about eight hours after a positive blood culture, has been touted as a breakthrough by the firm.
However, the Accelerate has faced numerous hurdles trying to place its technology into laboratories looking to obtain a rapid antimicrobial susceptibility result. As its CEO Jack Phillips said during last month's 39th Annual JP Morgan Healthcare Conference, "This is not a simple system and not a simple process because we're essentially changing the entire workflow of the hospital to treat these very serious patients."
In 2018, a year following the launch of its first product, the firm came up short of revenue expectations. At that time, the company noted that it was aiming to jumpstart its growth through a revitalized sales force and by emphasizing outcomes data.
For full-year 2019, Accelerate reported revenues rose 63 percent year over year, but it missed analysts' average estimate and the firm continued to cite delays in getting its instruments up and running in labs as the reason for slower than expected revenue growth.
Since then, Accelerate has revamped its implementation process with customers. "The point of this process was to get customers live quicker from when they sign contracts," Phillips said at the JP Morgan conference. At the beginning of 2020, the process took 11 months but it is now close to nine months and continuing to get better, he added.
In 2020, the firm grew its installed base of current Pheno systems by 63 percent despite restrictions on its customer interactions because of lockdowns during the coronavirus pandemic. At the end of the year, the firm had 268 customers running tests on its Pheno systems, and had converted many of them to long-term contracts, the firm said. In the US, where it is most active, the company went live with 120 Pheno systems in 2020, up 50 percent over the previous year, Meduri said.
The increase in placements has been driven in part, according to Accelerate, by the work it is doing with customers to promote economic and health outcomes data for Pheno. The firm now has more than 100 peer-reviewed publications since the launch, which describe "the value that the system brings to hospitals and patients, to infection control and antimicrobial stewardship efforts," Meduri said.
He added that hospitals are becoming increasingly concerned that the coronavirus pandemic is contributing to the rise of antimicrobial resistance. "We're seeing an overuse of antibiotics with COVID patients because physicians want to treat them in case they have a bacterial infection, but because of this they are being overtreated," he said. Accelerate is seeing traction, he added, among those hospitals that see the benefit of making sure an infection is bacterial and getting patients on an optimal therapy as quickly as possible.
The company said that overall for customers using its Pheno system, it is seeing decreases in antibiotic usage of up to two days, reductions in mortality and morbidity, and healthcare cost savings.
The firm has been also working to expand its market presence by increase the number of new bug-drug combinations on its Pheno system.
Last September, for example, it received FDA 510(k) clearance for enhancements to its Pheno system, including an expansion of its susceptibility testing menu for bloodstream infections to include four antibiotics used to treat Pseudomonas aeruginosa and to add the combination of P. aeruginosa and aztreonam to the Accelerate PhenoTest BC kit.
Additionally, Accelerate is looking to forge strategic partnerships and expand geographically for future revenue growth, Phillips said in his presentation last month.
The firm is currently conducting clinical trials to validate its Pheno system and ID/AST kit in China and both products are already live with a customer in Hong Kong. It sees China as "a major opportunity" because of the high prevalence of antimicrobial resistance there, Phillips said, and added that the company revamped its strategy in Europe last year to fine tune the markets it is targeting.
Also last year, Accelerate inked a collaboration with San Francisco-based BioCheck and its affiliate, Beijing, China-based Sophonix. Accelerate is distributing SARS-COV-2 IgG and IgM antibody tests and the BioCheck MS-FAST fully automated chemiluminescence immunoassay analyzer in the US, Europe, the Middle East, and Africa.
A crowded market
Accelerate's "plan to first complement their blood-based testing, and then look to expand into other types of samples is sound, and really the only way for them to go," Cornelius Clancy, chief of infectious diseases at the US Department of Veterans Affairs Pittsburgh Healthcare System, said in an interview.
"The large market here is in non-blood-based testing, which dwarves that of bloodstream infection testing," said Clancy, who is not affiliated with Accelerate but is an author of the T2 Biosystem's T2Bacteria pivotal study. Accelerate has "a track record with bloodstream infections and working relationships with labs in that area. Using their experience in this space and their technologies as the platform to move to testing other sample types is logical and feasible."
As infections that require quick and accurate treatments become more prevalent and antimicrobial resistance continues to escalate, the market for bacterial identification and antimicrobial susceptibility testing has become increasingly crowded.
Emerging companies developing such systems include Gradientech, Q-linea, QuantaMatrix, and Specific Diagnostics. Established in vitro diagnostic industry companies with placements in hospitals and reference laboratories for antimicrobial susceptibility testing include Danaher's Beckman Coulter, BioMérieux, Becton Dickinson, and Thermo Fisher Scientific.
Additionally, established diagnostics companies including BioMérieux's BioFire, GenMark Diagnostics, and Luminex produce multiplexed pathogen identification panels for infectious diseases, including sepsis. T2 Biosystems markets direct-from-blood molecular diagnostic panels that identify infectious-disease causing bacterial and fungal pathogens, and Molzym and Fraunhofer are developing a platform that operates directly from blood and other sample types.
"In the end, the key for Accelerate will be whether their platforms, by providing more rapid susceptibility data, will be useful to clinicians in guiding treatment decisions," Clancy said. "In particular, will the data generated lead clinicians to do something different in the treatment of enough patients to justify the costs of bringing an Accelerate system on board and running it?"
In continuing to grow its business, Accelerate will need to address some important hurdles, particularly in 2021 and 2022, Clancy said. For example, it will need to show that the incremental benefit from its products makes enough of a difference in the care of patients to justify costs for labs, hospitals, clinicians, and stewardship programs. Further, the strains on healthcare systems associated with lab expenditures and other investments during the coronavirus pandemic could impact purchasing budgets and affect adoption, he noted.
"Educating consumers and collecting data showing how the systems improve care and outcomes will play a big role in determining how successful they are," Clancy added.