Overview

Lab21 is a vertically integrated diagnostic company operating fully accredited service laboratories in the UK and the US, while at the same time developing and commercialising its own products for use in laboratories worldwide. 

• Development capability
• Proprietary technology: SPARQ™ Real-Time PCR
• Proprietary technology: Hepatitis C virus (HCV) drug resistance
• Proprietary technology: Genetic testing for CES-1 deficiency
• Proprietary technology: SmearCheck
• Proprietary technology: FastPlaque New Applications
• Proprietary technology: Selah Dots™
• Proprietary technology: Selah Tubes™

Lab21 has the capability to take biomarker assays through full development cycle, from IP or early technology to regulatory approval, manufacture and global commercialisation as product or as laboratory developed tests (LDTs).

For more information, please see Lab21 Partnerships pages.

The proprietary Lab21 SPARQ™ technology represents the latest generation of real-time PCR probe and primer technology.

The use of SPARQ™ technologies circumvents the use of other primers and probes weighed down by expensive licensing costs.

SPARQ™ enables time and cost efficient development and manufacture of very sensitive and specific real-time PCR assays suitable for any real-time PCR platform.

For more information, please contact partners@lab21.com.

Lab21 has patents in the area of HCV drug resistance genotyping. This intellectual property covers the analysis of genomic sequence variation in the viral serine protease gene, NS3. This enzyme has an important role in HCV replication and is one of the key areas of attack for the pharmaceutical industry.

The first HCV small molecule drugs are likely to be licenced within the next 12 months and include drugs which inhibit the activity of NS3 (telaprevir and bocepravir). Unfortunately HCV, similarly to HIV, is likely to select for resistant variants against these drugs, so it will be important to monitor patients for resistance. Lab21 is developing proprietary new assays to monitor the emergence of these genotypic variants and is open to discussions on sub-licencing the IP for alternative platforms.

Carboxylesterases (CESs) are members of an enzyme family that takes part in the hydrolysis and metabolism of diverse natural molecules. CESs also have a role in the activation of several prodrugs that are purposely formulated as esters to improve their pharmaceutical properties.

Lists of known and potential substrates for CES-1 metabolism are indicated in Tables 1 and 2. Collectively these drugs cover a cross-section of many therapeutic areas and are extremely important therapeutic agents, including gold-standard drugs in some cases.

Table 1. Examples of known substrates of human CES-1

Table 2. Examples of ester pro-drugs which are potential substrates of human CES-1

It has recently been reported that several polymorphic forms of the carboxylesterase-1 gene (CES1-) have been identified. These genetic variants result in the production of dysfunctional CES-1, resulting in altered metabolism or lack of activation of a number of pharmacotherapeutic compounds in Tables 1 and 2 including methylphenidate (MPH, Ritalin^®), oseltavamir (Tamiflu^®) and valacyclovir.  Additionally, since CES-1 has been shown to play a significant role in the metabolism of illicit drugs such as cocaine and heroin, as well as chemical warfare agents such as Sarin and VX, the inability to normally metabolise these molecules is also clinically important. Consequences of dysfunctional human CES-1 include the inability to liberate the active therapeutic drug; accumulation of the inactive prodrug and the potential for associated toxicities; and overall therapeutic failure in treating the targeted disease or disorder.

Further recent data has revealed the frequency of some of these mutations in different populations indicate that approximately 8% of all patients have a polymorphism in the CES-1 gene and a mean allele frequency (MAF) of 3-4% depending on race/ethnic group assessed. Given this frequency and the importance of some of the drugs metabolised by this route, it is likely that a very large number of patients globally across many therapeutic areas are not receiving optimal therapy, and that pharmacogenetic analysis should be seriously considered for patients receiving these drugs.

Lab21 has recently licenced intellectual property from the Medical University of South Carolina that allows us to exclusively develop new genotyping assays which can easily detect the presence of these variant genes. This information will clearly be a valuable tool for the clinical management of patients who are likely to be prescribed pharmaceuticals metabolised via CES-1. Laboratory-based versions of this test are currently in development and will be offered through Lab21 service laboratories in 2011, with subsequent launch of commercial assay kits at a later date.   

Application and Advantages of the CES-1 test

SmearCheck technology

The technology comprises an extensive panel of 120 unique, patented monoclonal antibodies (mAbs) that are directed against discrete cell populations within the normal differentiating squamous epithelium. These reagents have been produced using freshly isolated cervical cells, derived from hysterectomies, as immunogens for hybridoma fusions.

The SmearCheck reagents:

• Differ from antibodies raised against standard cervical epithelial cell-lines, which do not have specificity for genuine cervical phenotypes.
• Can be incorporated into simple point-of-collection devices for the detection of endocervical (columnar) cells for healthcare professionals who are taking the samples
• Can be used to undertake accurate delineation of cervical pathology and sensitive detection of cervical abnormality

The reactivity profiles of exemplar reagents are shown on chromogenically (immunoperoxidase) stained semi-adjacent frozen sections from an individual normal cervix in Figure 1. The antibodies invariably display an intense and highly specific reactivity with their target cell populations.  Moreover, these reagents consistently display the same staining profile on individual normal cervical specimens tested to date (data not shown).

From the reagent set, mAb 2C7 has been extensively analysed because of its particular phenotype and the specificity of cervical epithelial cells that it recognises. This antibody intensely stains endocervical columnar epithelium but shows no staining of squamous epithelium. Figure 1 shows the antibody reacting with an endocervical gland lying beneath overlying antibody-negative squamous epithelium.

Figure 1. Semi-adjacent frozen sections of normal cervix immunostained with monoclonal antibodies to differentiation-associated markers of normal cervical epithelial cells.

• FastPlaque MAP – for the rapid detection of infection or contamination with Mycobacterium Paratuberculosis.
• FastPlaque Listeria – for the rapid detection of Listeria species.

 

Nanoparticles are very small particles which often have very different properties from the bulk materials because of confinement effects. The assembly of small nanoparticles into larger molecular architectures or networks constitutes the nanomaterials research field.

Nanomaterials have a very broad range of applications in medicine and biotechnology, electronics, optical materials and structural materials.

Light emitting nanoparticles are highly sought out and utilized for optoelectronic, biochemical and electronics applications. Existing light emitting nanoparticles are either made of silicon or semi-conductors / metals (i.e. electroluminescent quantum dots). Materials and/or formation methods for these existing light emitting nanoparticles are usually expensive, complicated, limited in production capacity, and are often associated with toxicity (esp. lead or cadmium based semiconductor materials).

Selah Dots™ Competitive Advantage

Selah Dots™ are patent-pending brightly photoluminescent carbon-based nanoparticles targeted to revolutionize the cellular imaging markets by replacing fluorescent dyes and other contrast agents both in vitro and in vivo critical to early disease detection and rapid screening.

Selah Dots™ are built around a core of ordinary inert carbon that can be covalently passivated with biocompatible moieties. Selah’s highly innovative and scalable manufacturing process is compatible with standard process equipment. The robustness of our process produces highly consistent nanoparticles which are readily water soluble. Selah Dots™ promise the following performance benefits over competing imaging products:

The use of carbon solves many issues associated with previous nanoparticle approaches – it provides a cost-effective starting material and simple process route suitable for large scale production, and avoids toxicity concerns.

Selah Dots™ represents a new technology platform for the development of luminescent nanomaterials for a wide range of applications.

Carbon single walled nanotubes (SWNT) are unique forms of pure carbon, which are up to 100 times stronger than steel at 1/6th the weight (i.e. very strong, lightweight materials). These materials have impressive electrical properties, as they can conduct electricity up to 1000 times greater than copper. SWNT can transfer heat up to 10 times greater than copper. Given these phenomenal properties, SWNT will be the technology platform for a multitude of applications.

All existing processes to produce SWNT’s do so in the ratio of 1/3 metallic SWNT and 2/3 semi-conducting SWNT. SWNT customers who are trying to harness the highly conductive metallic SWNT are forced to accept the presence of the semi-conductive SWNT. Conversely, the SWNT customers who want to use the semi-conductive tubes are stymied by the presence of the metallic tubes.

Selah Tubes™ Competitive Advantage

Selah’s scalable process is the first to provide commercial quantities of metallic enriched or semi-conducting enriched SWNT’s. With these materials, dramatic improvements in the control of the electrical conductivity of SWNT will now be possible. The metallic SWNTs may be used for devices such as ultra-thin coatings that are optically transparent for use in LCD display, HDTV, etc. The semiconducting SWNTs are uniquely suited for sensors, transistors, and so on.

Other SWNT applications include:

• Aerospace: Electrically active, thermally conductive polymers and nanotube structural enhanced composites
• Defense: Enhanced lightweight ballistic protection and field sensors
• Energy: Hydrogen storage for fuel cells and battery electrodes
• Electronics/IT: Heat sinks; nanochips, and hard-drive heads
• Medical: New drug delivery medications and devices
• Telecom: Antennas and microwave amplifier devices
• Automotive: Fuel cells, structural components, and electronics
• Consumer: Flat panel displays, textiles, paint, efficient lighting, and water filtration