You may have heard of the enzyme-linked immunosorbent test, more commonly known as the ELISA test, which is used to measure molecules such as antibodies, antigens, and proteins in biological samples. Used to diagnose infections caused by the human immunodeficiency virus (HIV) as well as to detect the pregnancy hormone human chorionic gonadotropin (hCG) in urine samples via home pregnancy kits, these tests fall into the category known as molecular diagnostics.
The molecular diagnostics sector is a $23.2 billion industry, according to a report by Markets and Markets Research in 2022, and poised to continue growing by 5.4% in the next four years – with an estimated market value of $30.2 billion by 2027.
While a large part of the market is associated with reagents and polymerase chain reaction assays, contemporary techniques such as lateral flow assays and CRISPR-Cas based assays are making headway after the pandemic.
As new measures are being developed to spur faster and more efficient diagnoses, here are six molecular diagnostic companies to look out for.
Combining machine learning with diagnostic actions, ChromaCode, a California-based biotechnology company in the US, has developed HDPCR, cutting the cost of next-generation sequencing technology (NGS) for diagnosis.
The company’s proprietary technology encodes multiple targets in a single PCR reaction. Leveraging technology, the company has created two products – Tick-Borne Pathogen RUO Panel and Multi-Drug Resistance RUO Panel.
The tests are scanned with the help of ChromaCode Cloud, an enterprise data analytics platform. It does this by exporting the data into the program, which then provides a comprehensive visual representation – via graphs – as well as test reports.
The company has partnered with Indian biotech MedGenome to accelerate the commercialization of HPDCR-based assays in India and the Middle East.
The company has secured $94 million in financing since its founding in 2012. As recently as June, the company announced an undisclosed investment from venture capital fund Shimadzu Future Innovation Fund LP.
Based in the US, CirculoGene has a wide range of products in the diagnostic field. Through molecular profiling of the next generation of sequencing technology, TumorClear, it can help discover what treatment is best suited for a particular patient, particularly with regard to oncology. It can also be used to monitor a patient’s response to treatment, making the treatment process more efficient.
Focused on cancer diagnosis, ImmunoClear company is plasma cfRNA PD-L1, a pioneering tool for evaluating treatment effects. PD-L1 is a protein found in high amounts in cancer cells. Therefore therapeutically, it can be used as a predictive biomarker. ImmunoClear can tell if an immunotherapy drug like durvalumab is working, after a patient with non-small cell lung cancer (NSCLC) has completed chemo radiotherapy.
In addition, CirculoGene’s MSI Complete, which uses an MSI protocol consisting of eight markers, has been designed to quantify the degree of demonstrated DNA mismatch repair deficiency in patient tumors.
Founded in 2015, biotech raised a total of $9.2 million in six funding rounds, after receiving a $4.9 million investment from a debt financing round in March.
More than one million cases of sexually transmitted infections (STIs) are diagnosed every day. Leveraging the mechanism behind linear dichroism, Linear Diagnostics aims to diagnose an STI in minutes, 20 minutes to be exact.
By detecting shifts in the plane of polarized light when a target DNA sequence is bound to a detector – for example, an antibody that can identify antigens – companies are using EXPAR for rapid DNA amplification. This device is portable and does not depend on electricity because it uses a rechargeable battery. The company’s CT/NG tests play an important role in identifying gene sequences associated with bacteria that cause STIs such as Chlamydia trachomatis And Neisseria gonorrhoeae. Since most STIs are treatable, catching them early can help reduce the disease quickly.
A spinout from the University of Birmingham in England in 2011, Linear Diagnostics has received a total of £3.1 million ($3.95 million) in funding, along with a grant from the National Institute for Health Research received this month.
It is estimated that one in four dogs will develop cancer at some point during their life. As six million new cases are recorded annually in the US alone, early detection is always advisable. PetDx has devised a way to perform a liquid biopsy test to detect cancer in dogs.
The multi-cancer OncoK9 test is designed to separate blood samples taken from dogs – which contain fragments of cell-free DNA – into three components, namely plasma, buffy coat and hematocrit. From the plasma containing cell-free DNA, a DNA library is created for sequencing. The data was then analyzed using next-generation DNA library sequencing, and utilizing bioinformatics, the presence of cancer could be detected. Particularly for races that have been observed to have a higher risk of developing cancer, it is advisable to have an annual screening test – such as OncoK9 – at a young age.
Recently Studyit was pooled that the OncoK9 PetDx assay has the potential to improve early detection of cancer during health visits and expand the number of types of cancer detected at these visits, long before the onset of symptoms.
Formed in 2019, the US-based company raised $62 million in a Series B round that took place in 2021. To date, the company has raised a total of $72 million.
With a mix of platforms, Sherlock Biosciences relies on CRISPR technology and synthetic biology to manufacture diagnostic products. Synthetic biology involves redesigning biological systems for a different purpose such as manufacturing bio-based products.
The INSPECTR platform applies synthetic biology by using freeze-dried synthetic gene networks as a programmable molecular diagnostic tool, offering instrument-free diagnostics. This technology can be programmed to differentiate between targets based on single nucleotide differences. This is done through a molecular sensor which detects the presence of a nucleic acid target, after which a protein is produced. And thus, the diagnosis was obtained.
Named after the company, the Sherlock platform can examine the genetic makeup of DNA and RNA of pathogens. Using the CRISPR-Cas enzyme, it can detect whether a specific nucleic acid signature is present through an intelligent amplicon detection process, which in turn activates the CRISPR-Cas enzyme to signal its presence. This is read via a paper strip test as well as an electrochemical readout, which can be accessed on a mobile phone. To accelerate the discovery of this CRISPR-Cas enzyme, the company is integrating AI with bioinformatics.
For the diagnostic use of the Cas12 enzyme, Sherlock Biosciences was granted a US patent from Shanghai-based Tolo Biotech earlier this year.
Recently appointed its chief scientific officer, the four-year-old company is awarded a $25 million grant from the Bill & Melinda Gates Foundation in 2022. The company has raised a total of $138 million over six rounds of funding.
Renowned for the reliable diagnosis of COVID 19 in less than a day, polymerase chain reaction (PCR) tests are widely used to detect infection. French biotech Stilla Technologies has developed Crystal Digital PCR which enables microfluidic technology to precisely examine nucleic acids.
The sample is separated into arrays of thousands of individual droplet crystals. Then, the molecules, which have been fragmented, are amplified, where these reactions are tagged with fluorophores. Fluorophores are fluorescent markers that can re-emit light, and thus act as markers. The company’s naica system can read up to six fluorescent signatures in a single well.
Stilla Technologies’ PCR technology has a wide range of applications. It can be used to analyze liquid biopsies, offering a minimally invasive approach to detecting tumors. In addition, people who have had a transplant can be monitored through this diagnostic test to investigate possible cases of organ rejection.
As for its environmental applications, it can be used to identify food adulteration as well as test for the presence of pathogens in samples of human waste water.
Founded a decade ago, the company has raised a total of €67.2 million ($72.8 million) over four funding rounds, with a debt financing round already in 2021 as well as a previous round that raised €20 million ($21.7 million). ) in 2020.