Applied BioMedical (ABM) is developing the next generation of essential, rapid, point of care diagnostics for infectious disease and oncology in the Global South, North America and Europe.
Our core expertise in navigating public health procurement programs, securing non dilutive funding generated by legislative measures and leading innovative collaborations that secure dynamic IP in the diagnostic sector.
KEY MARKET INSIGHTS:
The global tuberculosis (TB) diagnostics market size was valued at USD 2.17 billion in 2023 and is projected to grow from USD 2.28 billion in 2024 to USD 3.58 billion by 2032, exhibiting a CAGR of 5.8% during the forecast period (2024-2032). The market for TB diagnostics is evolving as new technology is introduced.
According to the World Health Organization (WHO), neglected tropical diseases today impair the lives of an estimated 1 billion people. An estimated 480 000 people developed drug-resistant TB for isoniazid, rifampin, pyrazinamide and ethambutol without an accurate diagnostic platform capable of delivering accurate measures of rapid POC Antimicrobial drug resistance (ADM) in patients. China, India and South Africa have the highest number of TB cases globally and, together with Brazil, account for 46% of all new cases.
Current and future markets in four high-burden, emerging economies – Brazil, China, India and South Africa offer tremendous opportunities for new TB diagnostics, in part due to their national commitment to TB control in the face of high TB burdens, increased investments in new technologies, and growing economies.
The majority of TB cases in these high-burden countries are currently diagnosed by smear microscopy on a sputum specimen at peripheral microscopy centers. However, smear microscopy has low sensitivity and cannot detect extrapulmonary TB or drug-resistant TB. ABM is committed to meeting the global need for rapid point of care (POC) heat resistant diagnostics that are designed for use in peripheral settings and which are eligible for priority review by regulatory authorities, procurement agencies and attractive to sources of non-dilutive funding through established legislative vehicles such as the GAINS ACT and the Stop TB Act
The GAINS Act focuses on addressing antimicrobial resistance (AMR) by providing incentives for the development of new antibiotics through extended market exclusivity. While it has led to some advancements, the act has been criticized for promoting limited innovation, primarily encouraging modifications of existing antibiotics rather than fostering truly novel therapies. Its emphasis on traditional small-molecule antibiotics excludes promising alternative treatments like bacteriophages, which could offer more adaptive solutions to the growing threat of resistant pathogens.
The End Tuberculosis Now Act (House Resolution 1776), initially introduced on March 23, 2023, seeks to eliminate tuberculosis (TB) worldwide by enhancing efforts in prevention, diagnosis, and treatment, particularly in countries with high TB burdens. HR 1776 is a forward leap commitment in global TB control. However, while the act focuses on crucial areas, there is an opportunity to further strengthen it by incorporating innovative therapies, such as bacteriophages, which have the potential to combat drug-resistant TB strains. Additionally, a greater emphasis on improving and expanding access to accurate and rapid diagnostics is essential, as timely detection is key to effective treatment and prevention. Both this act and similar initiatives face challenges due to their reliance on traditional antibiotics and regulatory barriers that hinder the development of non-traditional, adaptable treatments. By broadening the scope to include emerging technologies and advanced diagnostics, the act will significantly enhance the impact in the fight against TB.
The GAINS Act (H.R. 6950, Rep. Rodgers) presents an opportunity for improvement by modernizing its approach to address antimicrobial resistance. While it emphasizes traditional antibiotics, it misses the chance to embrace groundbreaking therapies like bacteriophages, which have the potential to transform the fight against resistant bacteria. Rather than focusing solely on incremental adjustments to existing drugs, the act could better incentivize meaningful innovation that keeps pace with evolving bacterial threats. By broadening its scope to include adaptive biological therapies, we could more effectively tackle the global resistance crisis and foster sustainable solutions for the future.
The End Tuberculosis Now Act (S.288) provides measures to drug-resistant TB. By focusing almost entirely on scaling up outdated treatment methods, the act shows vision and responsibility in combating MDR-TB and XDR-TB. It prioritizes innovative therapies and diagnostics to deal with the most dangerous strains of TB. The act provides regulatory pathways for advanced treatments like bacteriophages to continue addressing one of the world’s deadliest diseases.
Following these measures ABM government relation firm is introducing
In collaboration with Paldara Pharmaceuticals, ABM has access to BSL2 Research and Development laboratory capacity as well as collaborators to develop thermal stability mechanisms for diagnostic capacities for the platforms now being pursued for acquisition and affords the
ABM is engaging in discussions with the NIH Office of Technology Transfer (NIH OTT) on acquisition of preclinical assets eligible for public health commodity procurement programs focused on rapid Point of Care (POC) TB diagnostics and on securing non-dilutive funding new diagnostic products needed to effectively address the global TB epidemic. Current diagnostic capacities include Sputum-based test for TB detection (“smear replacement test”), Rapid, non-sputum-based TB detection test (“biomarker test”) and Community-based triage test to rule out TB (“triage test”)
Next-generation drug susceptibility test confirmation capacities at microscopy centers rely on the evolution of POC rapid diagnostic capacities. ABM is engaging with NIH OTT to acquire a range of rapid, POC diagnostics including Diagnostic Antigens for the Identification of Latent Tuberculosis Infection and a Real-Time PCR and High-Resolution Melt Analysis for Rapid Detection of Multi-Drug-Resistant Mycobacterium tuberculosis with thermal stability characteristics that are essential in high burden settings to accommodate the needs of National TB Programs (NTBP)
In addition to rapid point of care heat resistant diagnostic for infectious AMR, ABM is also pursuing acquisition of IP for detection of indications of oncogenic pathogens and hematological malignancies that screens the patient’s DNA and RNA for single-nucleotide variants, insertions, deletions, gene fusions and copy-number variations at the gene and chromosome levels critical for understanding and treating hematological cancers which are growing in epidemiological significance. There are no comprehensive tests currently available commercially for precision analysis of myeloma and lymphoma.
ABM’s diagnostic acquisition and development are aligned with the highest priorities of global public health authorities addressing public health commodity procurement for AMR including rapid sputum-based diagnostics for detecting pulmonary TB at the microscopy level and rapid non-sputum-based diagnostics for detecting all forms of TB, community-based triage test for use by first-contact health-care providers to identify persons who need further testing and rapid drug susceptibility test for use at the microscopy level for the Global South that possess thermal stability characteristics.
All four tests are needed for use in decentralized peripheral settings rather than in reference or intermediate laboratories. If tests are to be successfully used in peripheral settings, they must take account of the lack both of infrastructure and of basic laboratory equipment and expertise. Target product profiles (TPPs) were developed for each of these high-priority tests. Today, no test on the market meets the key characteristics outlined in the product profiles, but novel tests will most likely be on the market within five years. The potential available market in the year 2026 estimated for these four priority products.