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Startup Credo Biomedical Launching Low-Cost Point-of-Care Influenza MDx

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NEW YORK — Molecular diagnostic developer Credo Biomedical is aiming to meet a growing market need for rapid point-of-care testing that combines the accuracy of PCR with the low cost of rapid immunoassays. The Singapore-based startup will launch its VitaPCR system along with a flu A/B test at the American Association for Clinical Chemistry conference in Anaheim, California next week.

Credo was founded in 2011 by Stephen Kao and Winston Wong, Jr. The company initially developed an instrument that it markets to the veterinary diagnostics sector, called the QubeMDx. This instrument can perform real-time PCR in 15 minutes, following five to eight minutes of sample preparation, and the firm has launched a number of assays on this system for viral, bacterial, and parasitic infections in cats and dogs. The QubeMDx instrument also uses two fluorescence channels per well.

Credo has now developed the VitaPCR for the human health market. It is a small real-time PCR instrument requiring two minutes of hands on time, with less than 20 minutes total time from sample to results. The VitaPCR instrument also has enhanced multiplexing capabilities compared to the firm's other system.

The VitaPCR system is simple enough to use that the firm is aiming ultimately to obtain CLIA waiver, according to Sofiane Bennacer, Credo's business development manager.

The speed of the VitaPCR system — real-time PCR within 18 minutes, with positive results reporting even sooner — is enabled by optimized fluorescent chemistries and reagents, Kao, the firm's CEO, explained in an interview.

However, the firm anticipates that the cost of its instrumentation and assays will be what differentiates it from the competition in the CLIA-waived molecular point-of-care testing space, Kao added.

Credo plans to provide its testing at a cost that is comparable to point-of-care lateral flow immunoassays, but without compromising on accuracy or speed. The first assay on the VitaPCR instrument is a combined flu A/B test. According Bennacer, the global burden of flu is huge, with 1.2 billion infections leading to as many as 1 million deaths worldwide each year.

Yet influenza is a disease for which there are vaccines and treatments, and for which we already know the best way to do diagnosis, Kao said. "More people die each year from influenza complications than from breast cancer in the US," he said, adding, "It doesn't make sense."

For example, in 2017 there were 40,610 breast cancer deaths in the US, according to the American Cancer Society, while the US Centers for Disease Control and Prevention estimates that influenza led to almost 1 million hospitalizations and claimed 79,400 lives during the 2017–2018 flu season.

The need for accurate and low-cost flu testing specifically at the point of care is also great. The typical treatment for flu — the antiviral drug called oseltamivir (Genentech's Tamiflu) — is approved for use only within the first 48 hours of the onset of flu symptoms.

Lateral flow immunoassays for flu, also known as rapid influenza diagnostic tests, or RIDTs, are frequently used for point-of-care flu testing. These had been so notoriously inaccurate that in 2017 the US Food and Drug Administration ordered they be reclassified from class I to class II devices. This has meant, among other changes, that RIDTs are now required to meet a minimum standard of 80 percent sensitivity compared to molecular methods.

Some firms have achieved improved sensitivity for their RIDTs by transitioning from having an end user visually read test results to using an automated results-reading instrument, Kao said. But molecular diagnostic instruments still have "orders of magnitude" of increased sensitivity over RIDTs, he added.

Furthermore, in inpatient settings, the standard operating procedure is to use molecular testing, Kao said, while outpatients are typically tested using RIDTs. But an inpatient was theoretically at one point an outpatient, he said, and the cost of molecular testing is the primary reason end users have cited to Credo in order to justify this protocol.

"It was through these interviews and the understanding of the market needs that we decided influenza was going to be our first target," Kao said. "We feel that there shouldn't be any differential treatment between the outpatient and the inpatient."

Many of the CLIA-waived point-of-care molecular diagnostic instruments currently available for flu testing require instrumentation that ultimately makes the testing costlier than RIDTs.

"Unfortunately, as much as there is a huge demand for rapid molecular diagnostic tests, it is not affordable for a lot of people," Bennacer said, adding that the cost of MDx is around three to four times that of RIDTs.

"This is where we come in as a company with our VitaPCR platform and influenza assay," he said, noting that each test will be priced at the level of a rapid test.

Consistent with previous reports, in its marketing materials Credo estimates that the Cepheid GeneXpert Xpress system has a cost of about $17,500, while Roche Cobas Liat and Abbott ID Now retail for approximately $12,500 and $8,500, respectively. The per-test costs for the Cepheid, Roche, and Abbott assays are approximately $50, $70, and $80 each.

Credo plans to make its instrument available for less than $6,000, and to sell its tests for around $20 each. Specifically, the firm's goal is an end cost $16 per target, so the flu A/B test would cost approximately $32 for the entire test kit, Kao said.

As previously reported, the 2018 Medicare payment rate for the specific reimbursement codes describing molecular testing for influenza A/B was $105.06, while combined influenza A/B and RSV testing was reimbursed $158.38. The reimbursement rate for RIDTs is approximately $16.50, although anecdotally, clinicians typically apply for reimbursement for both the flu A and flu B targets on combined tests.

To further lower costs to consumers, Credo also plans to make its instrument available through a leasing program. Thus, the system will allow clinicians to run more accurate testing wherever lateral flow tests had previously been performed, with a similar cost per test, Kao said. "We feel that we have cracked the problem," he said.

Although BioFire makes a CLIA-waived version of its FilmArray system that can test for flu, it is more difficult to compare because it is a larger instrument than the others in the point-of-care space and it also runs a multiplex panel to detect a total of 14 respiratory pathogens.

On the other hand, the CLIA-waived handheld Accula system from Mesa Biotech — which is exclusively marketed in the US as the Silaris system by Sekisui Diagnostics — is low cost. Kao noted, however, that this system uses chemistries that requires a visual readout rather than fluorescence technologies, and that it is standard endpoint PCR rather than real-time PCR.

That said, Mesa and Sekisui have also incentivized uptake by offering customers instruments for free when they purchase a minimum number of test cartridges, which cost approximately $30 each. Other point-of-care molecular diagnostic test makers have also reportedly begun shifting to placing more instruments under reagent rental agreements, as well.

Credo recently finished the presubmission process with the US Food and Drug Administration, Kao said. It hopes to obtain CE mark followed by FDA clearance and CLIA waiver by the end of next year and is working with FDA now to finalize its multisite clinical validation plan.  

Credo's pipeline also includes a a small respiratory panel of influenza and respiratory syncytial virus, as well as other respiratory panels.

The firm is also developing a test for risk typing of human papillomavirus infections. Credo plans to will offer a multiplex test that can detect 16 subtypes of HPV and separate out high risk HPV 16/18 strains, as well as report medium and low risk strains. These tests will vary by region, as the strains that account for the most cases of cervical cancer differ by population in Europe, the US, and Asia.

Although many government health agencies worldwide have emphasized molecular testing for HPV as a way to improve screening and reduce cervical cancer deaths, Kao said the uptake has been low in many places because the cost of MDx is too high. He also noted that many of the cervical cancer deaths worldwide are occurring in developing countries, where cost of testing is a particularly important constraint.

"Our hope is that we will offer the clinicians a better solution, which leads to better patient outcomes, less complications, and less deaths," Kao said.

Credo has been self-funded by its founders to this point, but the company expects that debuting its testing at AACC will increase awareness for its solutions, and perhaps also attract new investors. The firm is planning to demonstrate the real-time monitoring of fluorescent signals on its instrument at its AACC booth next week, and also hopes to connect with researchers and scholars, and potentially begin collaborations that could help evaluate the testing and its clinical impact.

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