You may have heard of the enzyme-linked immunosorbent assay, more commonly known as the ELISA test, which is used to measure molecules like antibodies, antigens and proteins in biological samples. Used to diagnose infections caused by human immunodeficiency viruses (HIV) as well as to detect the pregnancy hormone human chorionic gonadotropin (hCG) in urine samples through home pregnancy kits, these tests fall under a 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 is poised to steadily grow by 5.4% in the next four years – to a predicted market value of $30.2 billion by 2027.
While a good portion of the market is attributed to reagents and polymerase chain reaction tests, contemporary techniques like lateral flow assays and CRISPR-Cas-based assays made headway in the wake of the pandemic.
As various new measures are being developed to spur quicker and more efficient diagnoses, here are six molecular diagnostics companies to look out for.
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ChromaCode
Merging machine learning with diagnostic measures, ChromaCode, a biotech based in California in the U.S., has developed HDPCR, cutting costs of next-generation sequencing (NGS) technology for diagnoses.
The company’s proprietary technology encodes multiple targets in a single PCR reaction. Harnessing the technology, the molecular diagnostics company has created two products – the Tick-Borne Pathogen RUO Panel and the Multi-Drug Resistance RUO Panel.
The tests are scanned with the help of ChromaCode Cloud, the company’s data analytics platform. This is done by exporting the data onto the program, which then provides comprehensive visual representation – through graphs – as well as reports of the tests.
The company has partnered with Indian biotech MedGenome to accelerate commercialization of its HPDCR-based assays in India and the Middle East.
The company has obtained $94 million in financing since it was set up in 2012. Recently in June, the company announced an undisclosed investment from venture capital fund Shimadzu Future Innovation Fund L.P.
CirculoGene
Based in the U.S., CirculoGene has a range of products in the field of diagnostics. Through the molecular profiling of its next generation sequencing technology TumorClear, it can aid in finding out what treatment would suit best for a specific patient, particularly with regard to oncology. It can also be used to keep an eye on a patient’s response to treatment, making the treatment process more efficient.
Focused on cancer diagnosis, the company’s ImmunoClear is a plasma cfRNA PD-L1, a pioneering tool to evaluate the effect of treatment. PD-L1 is a protein that is found in elevated amounts in cancer cells. Therefore therapeutically, it can be used as a predictive biomarker. ImmunoClear can recognize whether an immunotherapy drug like durvalumab has worked, after patients with non small cell lung cancer (NSCLC) have completed chemo radiotherapy.
Additionally, CirculoGene’s MSI Complete, which utilizes a MSI protocol that consists of eight markers, has been designed to measure the level of DNA mismatch repair deficiency demonstrated within a patient’s tumor.
Founded in 2015, the biotech raised a total of $9.2 million in six funding rounds, having received $4.9 million in investments from a debt financing round in March.
Linear Diagnostics
More than a million cases of sexually transmitted infections (STI) are diagnosed every day. Leveraging the mechanism behind linear dichroism, molecular diagnostics company Linear Diagnostics aims to diagnose STIs in a matter of minutes, 20 minutes to be exact.
Through the detection of a shift in the plane of polarized light when target DNA sequences are bound to a detector – for example, antibodies that can identify antigens – the company uses EXPAR for speedy DNA amplification. The device is both portable and non-reliant on electricity as it runs on a rechargeable battery. The company’s CT/NG test is instrumental in identifying gene sequences pertaining to STI-causing bacteria like Chlamydia trachomatis and Neisseria gonorrhoeae. As most STIs are treatable, catching them early can aid in mitigating the disease quickly.
A spinout of the University of Birmingham in the U.K in 2011, Linear Diagnostics has secured an aggregate of £3.1 million ($3.95 million) in funding, along with a grant from the National Institute for Health Research received this month.
PetDx
It is estimated that one in four dogs will develop cancer at some point during their lifetime. As six million new cases are recorded every year in the U.S. alone, early detection is always recommended. PetDx has found a way to perform a liquid biopsy test for the detection of cancer in dogs.
The multi-cancer OncoK9 test is designed to separate the blood sample taken from the dog – which contains cell-free DNA fragments – into three components, namely, plasma, buffy coat and hematocrit. From the plasma that contains the cell-free DNA, a DNA library is created for sequencing. Data is then analyzed using next-generation sequencing of the DNA library, and utilizing bioinformatics, the presence of cancer can be detected. Particularly for breeds that have been observed to have a higher risk of developing cancer, going for annual screening tests – like OncoK9 – at a young age is advised.
In a recent study, it was gathered that PetDx’s OncoK9 test has the potential to increase early cancer detection during wellness visits and expand the number of cancer types detectable at these visits, well ahead of the onset of symptoms.
Formed in 2019, the U.S.-based company secured $62 million in funding from a series B funding round that took place in 2021. As of now, the molecular diagnostics company has received a total of $72 million in funds.
Sherlock Biosciences
With a variety of platforms in the mix, Sherlock Biosciences relies on CRISPR technology and synthetic biology to create diagnostic products. Synthetic biology involves the redesigning of biological systems for different purposes like the manufacture of bio-based products.
Its INSPECTR platform applies synthetic biology by using freeze dried synthetic gene networks as programmable molecular diagnostic devices, offering an instrument-free diagnostic measure. The technology can be programmed to differentiate between targets based on single nucleotide differences. This is done through molecular sensors that detect the presence of a nucleic acid target, after which a protein is produced. And accordingly, a diagnosis is obtained.
Named after the company, the platform Sherlock can examine the genetic makeup of pathogenic DNA and RNA. Employing CRISPR-Cas enzymes, it can detect whether specific nucleic acid signatures are present through the process of smart amplicon detection, which, in turn activates 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 expedite the discovery of these CRISPR-Cas enzymes, the company integrates AI along with bioinformatics.
For the diagnostic use of the Cas12 enzyme, Sherlock Biosciences was granted patent rights for the U.S. from Shanghai-based Tolo Biotech, earlier this year.
The four-year-old company recently appointed a chief scientific officer.
Sherlock announced a $17.5 million non-dilutive grant from Open Philanthropy Project in 2019, a $5 million grant from the Bill & Melinda Gates Foundation in 2020 and an additional undisclosed amount from the Bill & Melinda Gates Foundation last year. The molecular diagnostics company announced a $31 million series A in 2019, with a $80 million series B last year.
Stilla Technologies
Famed for its reliable diagnosis of COVID 19 in less than a day, polymerase chain reaction (PCR) tests are widely used to detect infections. French biotech Stilla Technologies has developed its Crystal Digital PCR which enables microfluidic technology to precisely examine nucleic acids.
Samples are separated into an array of thousands of individual droplet crystals. Then, the molecules, which have been compartmentalized, are amplified, during which these reactions are tagged with fluorophores. Fluorophores are fluorescent markers that can re-emit light, and thereby act as markers. The company’s proprietary naica system can read up to six fluorescent signatures in one well.
Stilla Technologies’ PCR technology has various applications. It can be used to analyze liquid biopsies, offering a minimally invasive approach to detecting tumors. Moreover, people who have undergone transplants can be monitored through these diagnostic tests to investigate potential cases of organ rejection.
As for its environmental applications, it can be used to identify food adulteration as well as test the presence of pathogens in human wastewater samples.
Established a decade ago, the molecular diagnostics company has raised a total of €67.2 million ($72.8 million) over four rounds of funding, with a debt financing round having taken place in 2021 as well as a previous funding round that raised €20 million ($21.7 million) in 2020.