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Group K Diagnostics Readies Liver Function Microfluidic for FDA Submission In Bid to Enter POC Testing


NEW YORK (360Dx) – With a plan to eventually launch a broad menu of tests using its disposable microfluidic platform, Group K Diagnostics is carefully preparing its entry into clinical point-of-care diagnostic testing.

The Philadelphia-based startup has a pipeline for product launches planned through 2020, but it will look to achieve US regulatory clearance in a methodical manner, Group K's Chief Strategy Officer Emilia Lopez-Ona said in an interview.

The timing of entry into diagnostic testing markets may not be far off. The firm is preparing to launch a six-biomarker liver function test in the US this summer subject to receiving US Food and Drug Administration 510(k) clearance.

In clinical trials at Penn Medicine, the liver function test — consisting of markers for total protein, albumin, bilirubin, alanine transaminase, aspartate transaminase, and alkaline phosphatase ­— had an accuracy rate of 98 percent or higher for whole-blood testing, Group K said.

Later this year, the firm anticipates launching a comprehensive metabolic panel based on the same technology platform and including the liver function markers and test along with markers for kidney function and diabetes that include blood urea nitrogen, creatinine, potassium, sodium, calcium, and glucose.

Group K said that the microfluidic point-of-care platform it is developing provides test results in 20 minutes and could eventually conduct up to 40 tests, including for infectious diseases, liver cancer, and routine clinical chemistry tests, among others.

Group K has yet to publish a peer-reviewed study that describes the use and validation of its technology. Publishing peer-reviewed papers is on its radar but not currently a priority, the firm told 360Dx.

For the present, the firm is focusing resources on developing, validating, and launching its first set of tests. It said that it believes the simplicity, convenience, and low cost of the disposable platform it is developing will drive broad adoption in point-of-care testing markets.

"The liver function test would certainly be helpful for liver doctors and gastroenterologist," said Scott Friedman, chief of the division of liver diseases at the Icahn School of Medicine at Mount Sinai, who is an unpaid advisor to Group K. "Having a test available and performed by a medical assistant while the patient interacts with a physician is a very clever attempt to address an umet need," he said.

Friedman said that he invested an undisclosed amount in Group K after seeing a company presentation to Mount Sanai in his role as dean of therapeutic discovery at the hospital system.

"The liver test could be helpful to healthcare workers in places that are more remote where you don't have access to labs right away, but it will also be useful to doctors working in a modern medical setup," he said.

In principle, adopting the test could save an extra trip to the doctor because frequently a patient goes home following testing, and depending on the test result, the patient might have to return to a clinic.

In the Mount Sinai health system, liver test results normally come back within a day because it has its own clinical laboratories, he said, adding that this is a normal procedure for many but not all hospital systems.

With the Group K platform, "all of that could be accomplished earlier and in one visit because the doctor has the information needed to decide whether more testing or immediate therapy is appropriate; it gets the patient to the next branch of the treatment plan faster," Friedman said.

Multi-marker platform

Group K CEO Brianna Wronko, a graduate of the University of Pennsylvania, founded the firm in 2016, and began developing a point-of-care platform small enough to fit in the palm of the hand.

The platform works by loading a sample from a finger prick to release blood. The flow of blood over chemical reagents, specific to various biomarkers that have been dried on the device, induces a colorimetric change that's read by a smartphone and is reflective of a test result.

The firm said that its paper-based microfluidic, which is called the MultiNostic platform, has potential as a basis for diagnostic tests that can be performed with minimal training and be easy to transport, store, and ship, giving the device potential for application in low-resource settings globally.

Use of the microfluidic system for testing would eliminate the inconvenience and cost associated with large laboratory equipment and the infrastructure required to operate it, the firm said.

Last November, it announced that it had secured $2 million in Series A funding, on the heels of a $425,000 round of angel funding completed in September.

The firm has used some of the funds to support completing clinical trials in advance of its first 510(k) submission. It completed inpatient clinical trials at Penn Medicine for its liver function test and is now applying for FDA clearance, Lopez-Ona said.

The firm anticipates receiving regulatory approval in July and launching a commercial test in late August or sooner for use by hospital outpatient clinics. It has inked its first contract for the supply of the test, subject to receiving regulatory approval, with the LeHigh Valley Health Network in Pennsylvania.

By Q4 of this year, it anticipates that 350 outpatient hospital clinics will be running the liver test. Discussions are ongoing with hospitals throughout the US, including in the mid-Atlantic, on the West Coast, and in the Northeast, Chicago, and Florida, Joseph Geromini, Group K's chief operating officer, said in an interview.

He noted that for distribution, the firm is engaging with laboratory organizations that currently ship samples from their member clinics to outside laboratories. Working with Group K, the distribution firms will supply its test strips to hospital clinics so that their physicians can conduct testing and generate revenue streams for themselves that labs would normally generate from testing outsourced by hospitals in some instances, Geromini said.

Group K expects that around December it will have regulatory clearance to market the comprehensive metabolic panel being developed and currently in preclinical trials. The platform for the panel — which consists of biomarkers for liver function, kidney function, and diabetes — is similar to that used by the liver function test under review by the FDA, Lopez-Ona said.

The design concept enables the firm "to streamline [its] research and development initiatives," she said, adding that "it allows us to streamline our manufacturing processes … and people operating the test will not have to be retrained when new diagnostic tests are rolled out on the platform."

In all, its pipeline includes tests for infectious diseases, such as sexually transmitted diseases, hepatitis, and HIV, as well as routine blood chemistry tests, such as a lipid panels and prostate specific antigen, and many others.

In creating a testing pipeline, the firm uses as guidance the frequency at which tests are ordered for patients requiring urgent results, Lopez-Ona said, adding that applications in which results are actionable and enable immediate adjusting of a care plan are also prioritized.

As its business plan evolves, the firm anticipates eventually expanding sales channel activities to include marketing to physicians in primary care settings and expanding geographically to additional regions of the world, including establishing distribution at the point of care in resource limited settings.

In March, the firm announced that it had inked an agreement with the US Centers for Disease Control and Prevention to design and evaluate a prototype reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) assay for the detection of Zika virus (ZIKV) RNA at the point of care.

The technology platform, different from that used to run its comprehensive metabolic panel, is specific to the CDC collaboration, the firm said.

Geromini noted that this month the firm plans to meet with the CDC to create a framework for collaboration that will first focus first on Zika testing but could expand to other areas of infectious disease testing, including HIV diagnostics.

Point-of-care competition

Despite its high profile collaboration with CDC and the potential for regulatory approvals, Group K can expect to encounter competition from established diagnostic industry behemoths in the POC space. Many of the established companies provide equipment purchased and used by laboratories to which clinics send samples for testing and some, including Abbott Laboratories and Siemens Healthineers, also sell point-of-care test instruments with broad menus that have been approved by regulators and have already achieved significant adoption in hospitals.

For example, Siemens Healthineers is marketing its Epoc point-of-care system, which includes measurements of lactate, pH, partial pressure of oxygen, partial pressure of carbon dioxide, sodium, potassium, ionized calcium, hematocrit, glucose, lactate, creatinine, chloride, blood urea nitrogen, and total carbon dioxide.

Abbott's current-generation i-Stat instrument, launched in 1991, tests for 26 analytes, spanning blood gases, blood chemistry, coagulation testing, and immunoassays, and the firm is developing an advanced version of the instrument that has already received CE marking.

But according to Geromini, the cost structure associated with Group K and its microfluidic diagnostics platform is "nothing like" anything else currently in the market. The company expects that the price at which it can make available its paper-based disposable test will help drive adoption. With low manufacturing, materials, and other costs, it plans to sell its liver function test for less than $8 per strip, which should generate margins for clinics using the diagnostic platform, Lopez-Ona said. The medical conditions targeted by its first set of tests — for liver function and the comprehensive metabolic panel — are reimbursed through existing CPT codes, she noted.

Friedman said that Group K has run a number of different ideas by him, but the "main point is they don't intend to restrict their initiatives to launching a liver test. They're a very small company and they are adhering to realistic goals while looking to get traction."