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Co-Diagnostics Expanding Manufacturing for TB Testing Kits in India

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NEW YORK (GenomeWeb) – Molecular diagnostics kit manufacturer Co-Diagnostics is expanding its manufacturing footprint with a nearly completed new plant in Vadodara, India, a few hours north of Mumbai.

The Utah-based firm plans to use its recently minted relationship with a large Indian pharmaceutical company to promote uptake of its tuberculosis tests and other infectious disease assays in hospitals and private labs there.

Co-Diagnostics has recently discovered that its core chemistry – a PCR reagent called Co-Primers - can enable single-tube multiplex SNP genotyping, which opens up new horizons in terms of applications, CEO Dwight Egan said in an interview.

The Co-Primer technology is a proprietary chemistry that attaches primers to probes with a polyethylene glycol-based linker. This method prevents the formation of primer-dimers, reducing them by as much as 2.5 million-fold, which in turn enables multiplexing, according to the firm's own published research.

"We have known for quite a while that we have had very high multiplexing capabilities, but what we've been able to determine in the last year is how well we can also do SNP genotyping, and that we can also do multiplexing of SNP genotyping" Egan said.

The resources to validate the technology have come from an influx of cash in the past year or so. Co-Diagnostics' IPO last year raised $7.1 million, as previously reported. The company also recently closed a non-convertible debt instrument for $2 million. And, to lay the groundwork for additional funds in the future, this week the firm filed a Form S-3 shelf registration statement to sell up to $25 million shares.

"We have set the stage to be able to have access to the capital markets as appropriate … but having concluded and banked a couple million dollars, along with the cash that we had from our IPO, we have a comfortable environment" moving forward, Egan said.

India is a central focus of Co-Diagnostics' infectious disease initiatives. Co-Diagnostics formed a joint venture in India last year, called CoSara, with Synbiotics Limited, a subsidiary of a large pharmaceutical manufacturer called Asence Incorporated.

These partners have "contacts with the government and with the commercial market in India," Egan said, and that will help Co-Diagnostics gain more access for its products.

According to the agreement, CoSara will secure the applicable regulatory approvals in India, allowing for the sale and distribution of CoSara-branded products, and the joint venture will have the exclusive Indian manufacturing rights once construction of the new manufacturing facility is completed.

The CoSara joint venture broke ground in India in October last year, and the firm announced in March that principle construction is complete.  

"The plant will be up and operating within a few months and be able to produce [our products] right in the country," Egan said, adding that the firm has a number of customers in private labs, hospitals, and chain labs who have indicated they will be adopting products.

The joint venture now has licenses to manufacture several different products there, Egan said, and over the next year it plans to offer tests manufactured in the Indian facility for the Indian market as well as others. Those include a tuberculosis test, as well as assays for Zika, hepatitis B and C, malaria, HIV, and human papillomavirus.

Tuberculosis testing has been a major focus of Co-Diagnostics' initial strategies in India, and the firm recently received CE marking on a kit to detect two regions of the Mycobacterium tuberculosis genome. "The targets that we chose were after doing a lot of different tests in the country with various populations," Egan said.

The firm has done research for a number of years with key opinion leaders and various laboratories and hospitals in India, he said. "We have developed a very accurate test in terms of detecting tuberculosis … available at a very competitive price compared to what had traditionally been available to people in India." The test will be offered at a price of $10 per test, which happens to be on par with the public sector concessional pricing for Cepheid tuberculosis assay cartridges.

Egan said the firm has honed its strategy to market kits into labs — rather than develop a cartridge-based system that might have a higher cost of consumables in the private sector, or a point-of-care platform which would tend to have low throughput — based on its experience in India.

Although there may be a place for point-of-care testing in remote locations, Egan noted that the existing infrastructure in India can be used to transport a sample from almost anywhere in the country to a lab within about six hours, and this could be useful considering that higher throughput testing may be needed to address the vast TB problem.

"We have an environment where 1,000 people a day are dying with tuberculosis; if that were happening in the US we'd leave no stone unturned to figure out how we were going to get an appropriate diagnostic to the population and appropriate therapy," he said. India has 400 million people that are infected with latent tuberculosis and about 2.25 million new cases every year, he added, making it "critical that there is a diagnostic available that they can actually afford, so that they can then get in line for treatment."

Cepheid, a major player in TB testing in India, recently launched a near-patient version of its cartridge-based testing platform, called the Edge, that will be manufactured in India. By contrast, a few years ago Abbott began marketing a CE-marked high-throughput, lab-based test for multi drug-resistant TB which was purportedly the first test on the market to identify resistance to both rifampin and isoniazid. That test was designed for centralized lab use on the Abbott m2000, and the firm has suggested that centralized lab testing has some advantages in regions with a high TB burden.

Egan would concur. "We're as interested in point of care as anybody, when and if it is going to get legs, but we don't see it yet," he said, further noting that large reference labs "have done just fine during this period of proliferation of cartridge-based and single-purpose machines."

The TB test can run on standard lab equipment, but Co-Diagnostics also has a contract with Bio Molecular Systems, manufacturer of the MIC thermal cycler, to provide that system to interested customers. The MIC can test 46 patient samples at a time, and Egan said his team has found the device to be "really terrific" and plans on continuing to offer it.

While the firm's plans in India stem in part from a desire to put a dent in the global TB health crisis, he also acknowledged that there is a large potential market in that country. In contrast, the US has much fewer TB cases each year, so Co-Diagnostics does not currently plan to pursue regulatory clearances with the US Food and Drug Administration.

"We're not going to ignore the US market ultimately, but as far as getting an initial foothold, its lower hanging fruit for us in the developing world," Egan said.

And, now that the firm believes that its "ability to multiplex in many respects is unique," as Egan said, it plans to build its TB test into one that detects rifampin and isoniazid resistance as well. "We have a number of people who will really jump on the product when we also provide the drug resistance," he said.

Furthermore, the firm is also developing assays in agriculture, livestock, and aquabio, as well as in liquid biopsy for cancer detection, he said. It recently began a collaboration with the lab of Shan Wang at Stanford University, who Egan said approached the firm seeking to develop methods to detect multiple genetic mutations in the EGFR gene within a single reaction, including those most frequently occurring in lung cancer. Wang has been developing MagArray biodetection chips, among other projects, and is currently a PI on a clinical trial to identify circulating tumor cells in lung cancer.

In addition to manufacturing its own multiplexed tests for the liquid biopsy market, the firm plans to license the chemistry and has been talking with other companies that plan on claiming a stake in that area, Egan said.

"Whether they are using PCR or NGS, we have broad applications with our science," he said. The firm will, however, continue to make its own tests, in part because this will allow it to make them available in the developing world.

"We believe that making a product that can be affordable in the developing world is a great benefit to the planet," Egan said.

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