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Pointcare Genomics Awarded NCI Contract to Develop cfDNA Cancer Dx Tech


NEW YORK (GenomeWeb) – Startup Pointcare Genomics announced that it has been awarded a Small Business Innovation Research contract from the National Cancer Institute worth up to $2.3 million for the development of a technology designed to detect circulating cell-free DNA biomarkers on a luminometer or a portable glucose meter.

Pointcare will initially receive $300,000 in Phase I SBIR funding to establish proof of principle for the technology, and could then receive an addition $2 million in Phase II funding to optimize and clinically validate both the luminometer- and glucose meter-based tests. Assuming this work is successful, the firm anticipates commercializing the products within two years.

Pointcare was founded in June 2014 around a technology being positioned as a cheaper and faster alternative to PCR-based DNA and RNA biomarker detection, CEO Tonny Johnson told GenomeWeb. Exact details about the approach, however, are not yet being disclosed for competitive reasons, he added.

According to Johnson, the initial round of NCI funding will enable Pointcare to generate proof-of-concept data around methylated SEPT9, which is involved in tumor cell migration and invasion and is an established biomarker for colorectal cancer. 

Notably, the company is aiming to adapt the technology to run on two different platforms: a luminometer and a glucose meter. The former, Johnson said, will be geared for use by large labs that likely have such instrumentation already on hand. The latter, meanwhile, will be positioned for use in small clinics or by caregivers without technical expertise such as nurse practitioners.

He added that the luminometer approach is more developed and that he anticipates being able to demonstrate in Phase I that it offers the same DNA-detection sensitivity as PCR-based methods, but with readouts available in two to three hours versus a full day.

With the glucose meter, Pointcare is aiming to simply show that it can detect the target DNA. Achieving clinical sensitivity will require additional optimization during the second phase of the NCI contract, which will be conducted with an undisclosed industry partner that has experience in the area and who will help modify the meter's hardware, software, and test strips.

Johnson said that the Phase I portion of the grant will involve testing the technology in existing serum samples from colorectal cancer patients that Pointcare will obtain from collaborators, as well as spiked control samples.

If the data from this effort meets the NCI's requirements, the company will receive $2 million to move into a clinical validation study that it will design with the agency to produce the data necessary to secure regulatory approval for the tests. 

Although the technology is being developed under an NCI contract, Johnson said that Pointcare will retain all commercial rights and that it could begin marketing the tests in one to two years, initially as laboratory-developed tests and later as approved diagnostics.

Should Pointcare be successful with its colorectal cancer diagnostic, Johnson said that the firm hopes to expand into other cancer indications such as lung cancer and leukemia, where identifying the particular genetic mutations behind a patient's disease can allow a physician to tailor a treatment regimen. The company has also conducted preliminary research around a heart attack diagnostic, but has put that program on the backburner to focus on oncology, he added.