The “omics” revolution (proteomics, phenomics, epigenomics, etc), which emerged following the 2003 completion of the human genome project, has advanced the biological understanding of diseases and has changed how medical professionals treat diseases and determine treatments.cSpecific treatments are tailored for each patient based on their genetic structure, which paves the way for the beginning of personalized medicines.
Dive deeper into molecular diagnostics with the DataFox Molecular Diagnostics public list.
Such new diagnostics technologies allow health professionals to better predict disease susceptibility, detect diseases earlier and more reliably, and determine an individual drug’s expected response. And with the cost of genomic testing decreasing, the demand for diagnostics will likely rise in the next decade:
One development from the omics revolution is molecular diagnostics. Molecular diagnostic tests detect and identify diseases at the molecular level. These tests typically assess the deoxyribonucleic acid (DNA), ribonucleic acid (RNA) or the proteins the patient expresses. One such test is the testing of KRAS mutation in Colorectal Cancer (CRC). KRAS testing in CRC identifies patients with KRAS mutation who would not benefit from the traditional treatment using anti-epidermal growth factor receptor (EGFR) antibodies, such as cetuximab (Erbitux®) developed by Bristol-Myers Squibb and panitumumab (Vectibix®) developed by Amgen.
Molecular Diagnostics Industry
In 2012, the global market for diagnostics was valued at $ 45.6 billion. According to market study by Frost and Sullivan, the value of the global market for diagnostics is estimated to reach a market size of $64.6 billion in 2017, growing 7% annually over the next few years and concentrating 60% of the market in the US and EU. The US diagnostics market was worth around $15.5 billion in 2012 with estimated growth rate of around 5 % for the next five years. And molecular diagnostics currently accounts for 11% of the overall diagnostics market and is forecasted to grow at 12% annually until 2017.
Molecular Diagnostics Big players
Though the diagnostics market has grown in the past decade, most big biopharmaceutical companies do not invest heavily in this field. The key players in the molecular diagnostics sector include Roche Diagnostics (Switzerland), Gen-Probe (U.S.), QIAGEN (Netherlands), Abbott Laboratories (U.S.), bioMérieux (France) and Beckman Coulter (U.S.).
A leader in traditional diagnostics, Roche had initial success investing in molecular diagnostics when it patented in 2006 the polymerase chain reaction (PCR). Roche encouraged the application of PCR by issuing licenses for PCR and earned an estimated $2 billion in licensing royalties.
bioMérieux, a world leader in in vitro diagnostics, continues providing diagnostic solutions in various industries such as agri-food, clinical, biopharmaceutical, veterinary, and cosmetics. bioMerieux signed an agreement in 2015 with San Diego-based Astute Medical to develop NephroCheck Test, a test that detects protein biomarkers for acute kidney injury, a disease affecting up to 50% of severely ill patients.
Gen-Probe was a pioneer in improving assay sensitivity of bacterial identification and developed its own homogeneous hybridization protection assay technology. In 2012, Hologic bought Gen-Probe in an effort to grow Hologic’s diagnostics business, especially in the infectious diseases market.
QIAGEN has multiple detection systems for viruses and bacteria in its portfolio. QuantiFERON-TB Gold In-Tube® (QFT) has become the gold standard for latent tuberculosis (TB) detection. And digene HC2 HPV® Test is the standard for diagnosing cervical cancer. The test is highly effective in identifying human papillomavirus (HPV).
Abbott Laboratories is investing heavily in R&D to accelerate Abbot’s sales growth in the diagnostic market. Abbot is developing new innovations in immunoassay, blood screening, and hematology. Abbot owns a wide range of molecular testings in genetics, infectious diseases, and oncology. In January 2015, Abbott announced strong fourth-quarter revenues in their diagnostic business with 8.6% sales increase.
While most biopharmaceutical startups are engaging in drug discovery and development, some are pursuing clinical diagnostics. T2 Biosystems, based in Massachusetts, has developed T2MR, a technology platform that can detect minute amounts of molecular targets (DNA) immunodiagnostics (proteins), and hemostasis measurements. Utilizing nanotechnology, T2 Biosystems’ products have broad applications in clinical diagnostics of sepsis and hemostasis.
OpGen filed for an initial public offering March 3, 2015, hoping to raise $37.4 million. In the company's IPO filing, OpGen described itself as "an early commercial-stage company using molecular testing and bioinformatics to assist health care providers to combat multidrug-resistant bacterial infections." OpGen's flagship product, Acuitas, targets multi-drug resistant organisms.
Ohmx Corporation develops molecular diagnostic technology. Ohmx Corporation uses an electronic detection platform, which utilizes modified electrodes to collect digital data from clinical analyte. Ohmx currently has several significant investments in biosensor chips, portable point-of-care systems, and prostate cancer biomarkers.
Another promising startup in this field is Proteocyte Diagnostics, which was founded in August 2011. This Canadian company makes and markets StraticyteTM, which helps clinicians to accurately identify oral lesions that could develop into head and neck cancers.
QuanDx has developed a novel diagnostic technology, known as Yin-Yang Probes, for homogenous nucleic acid detection. This unique invention is basis of QuanDx’s detection kits for diagnosing leukemia, lung cancer and methicillin-resistant Staphylococcus aureus (MRSA) infections.
Follow the top companies developing molecular diagnostics with the DataFox Molecular Diagnostics public list.
FDA Impact on Molecular Diagnostics
In 2014, Food and Drug Administration (FDA) announced the intention to tighten the regulation on molecular diagnostics tests. Molecular diagnostic tests are laboratory developed tests (LDTs). Previously, LDTs were not subjected to stringent FDA regulation and were certified under the Clinical Laboratory Improvement Amendments (CLIA). However, as LDTs play a more critical role in the healthcare system, the FDA expects labs developing LDTs to report tests and seek approval before clinical application.
Stricter regulation by FDA may actually benefit the diagnostics sector. Industry experts, Brook Byers of Kleiner Caufield and Byers and Mara Aspinall of Roche, noted that setting a regulation standard would inspire more confidence by physicians and patients in the reliability and accuracy of diagnostics.