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GeneCapture To Enter Point of Care MDx Market With Affordable Infectious Disease Screening Platform

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NEW YORK (GenomeWeb) – Startup GeneCapture has announced that it plans to enter the point of care diagnostics market by screening for common infectious diseases in vulnerable areas with its portable genotyping platform.

Based in Huntsville, Alabama, GeneCapture spun out of the University of Alabama at Huntsville (UAH) in 2009 as a partnership between CEO Peggy Sammon and CTO Krishnan Chittur. Chittur previously developed the original gene probe technology underlying GeneCapture's platform at UAH and later applied for a patent.

Since 2009, GeneCapture has improved the screening process to quickly detect bacteria, viruses, and fungal species in liquid samples.

According to Chittur, the diagnostic kit can use a patient's blood, saliva, or urine sample for screening. Researchers collect the patient samples using disposable cups, requiring anywhere from 1 to 3 milliliters depending on the sample type. To prepare the liquid sample for extraction, researchers filter concentrate containing the pathogen and then lyse the sample to release its RNA.

The test uses customized, synthetic nuclear probes to capture a pathogen's RNA signatures through hybridization. Hundreds of different probes on a microarray directly match a wide variety of pathogenic genetic material.

Sammon touted the platform's ability to detect a broad spectrum of infectious diseases, noting that the microarray will ultimately have all the probes on board to detect up to 200 pathogens from a single run using the team's customized detection algorithms.

Chittur explained that after hybridization, the conformation of the stem loop probe alters so that universally labeled oligonucleotides containing a fluorescent marker can attach to it. The fluorescent presence on each oligonucleotide highlights which specific probes have been activated. Sammon explained that the overall process requires 45 minutes.

"We've designed over a hundred probes to identify at least 25 different diseases for clinical validation over the last year and a half." Sammon said. "We want the medical professionals to have a quick way to identify the cause of the infection without having to stratify various scenarios."

When selecting which diseases to initially target in the testing kit, Sammon noted that GeneCapture sought to tackle areas where it could make an immediate impact on the medical community. The firm therefore explored issues linked to upper respiratory infections, gastrointestinal infections, and urinary tract infections (UTIs).

"In our search, we were surprised to learn how subtle UTI were in elderly populations, which swayed our starting point, as it allowed us a place to make an impact very quickly," Sammon explained.

Sammon and Chittur acknowledged that GeneCapture encountered technical limitations related to sample preparation and optical scanning while developing its infectious disease platform. Over the past year, the firm faced challenges minimizing the amount of equipment needed to optically scan sequences in rugged environments. In addition, GeneCapture's team researched a variety of sample collection types before they chose to pursue the one-use disposable cartridge strategy because of its easy disposal, durability for storage and shipment, and ease of manufacture.

In an email, Sammon explained that the one-use cartridge "can withstand the rigors of shipping and the possible temperature extremes that could be encountered." GeneCapture uses a specialty US manufacturer to develop the disposable cartridges, though she declined to name that manufacturer.

As part of a preliminary UTI clinical validation study, GeneCapture partnered with different UAH and local medical groups to identify UTIs in the urine of two patient cohorts. The researchers collected samples at least twice a day and performed sample prep manually at the GeneCapture laboratory. They then assayed the samples on two versions of the firm's prototype UTI captor panel, searching for species that potentially caused the disease.

In the first cohort of eight samples, the researchers found a 100 percent clinical sensitivity and specificity in the data. In a second cohort of 31 samples, the team had a clinical sensitivity of 87 percent and 100 specificity. In the study's white papers, which are currently under peer review, preliminary results suggest that UTIs in the patients stemmed from Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterococcus faecalis, Staphylococcus aureus, or Candida species.

Since Chittur's original patent for the genetic probe technology, which the firm has licensed from UAH, GeneCapture has published five additional patents linked to the test kit. Sammon explained that the patents, some of which have been granted while others are still pending, center on quick sample prep, usage of small disposable cartridges, and applying the collected data on a microarray.

In terms of commercialization, GeneCapture is currently developing a pre-manufacturing model of the test for clinical studies. Sammon highlighted that the firm has a variety of prototypes its used over the past year, and that it plans to submit the pre-manufacturing model to the US Food and Drug Administration for 510(k) clearance later this year.

"We aim to commercialize a UTI and biological warfare agent [detection] assays, as we've seen a lot of interest from our investors and the markets," Sammon explained. "As we add more probes to the original assay, it will become more and more useful for looking at other infectious diseases."

GeneCapture's current funding has stemmed from angel investors and Alabama Launchpad, a University of Alabama non-profit that supports University of Alabama-based startups. While it declined to disclose its total amount of funding, GeneCapture noted that it has raised $200,000 in seed funding through Alabama Launchpad's LEAP Alumni Startup competitions. In addition, the firm is actively searching for future partnerships with commercial partners, especially in product distribution.

GeneCapture aims to keep the entire test cost under $20 by having the internal components as basic as possible. The firm's genetic probes, including the UTI captor probe, will also be integrated into the existing prototype.

Aware that the market for portable infectious disease platforms is bustling and very competitive, GeneCapture believes that its technology will stand out because of its portability and versatility. The firm aims to keep sample preparation requirements as simple as possible to minimize potential downstream errors. Chittur also noted that GeneCapture's platform differs from other diagnostic tools because it does not require enzymatic amplification.

Sammon envisions the platform's use in areas that are prone to infectious outbreaks, including nursing homes, field hospitals, airports, cruise ships, and doctor's offices.

"We've met with several clinics and doctors who have shown [us] how their [clinical] process works, and how we could seamlessly fit into their routine," Sammon said. "Our major goal is to get this platform CLIA-waived and become a simplistic, inexpensive process at the doctor's office."

Louise O'Keefe, director of the UAH Faculty and Staff Clinic, argues that the UTI prototype will help expedite patient diagnosis and eventual treatment. She and her clinic also participated in the product's validation trial for UTIs at UAH.

"If [GeneCapture] is going to market [the test] at below $20, that means a freestanding clinic without a lab will be able to afford it, especially in ... low-income areas for individuals with no insurance, and to have something like that will help my patients," O'Keefe explained.

While GeneCapture's technology identifies the bacteria in less than an hour, O'Keefe does worry about the test's lack of "antibiotic sensitivity". In terms of bacterial causes of UTIs, she explained that clinicians want to know which antibiotic would be most applicable and effectively kill the specific bacterial species in the patient.

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