The concept of organ transplantation came as a significant breakthrough in the field of medicine. Over the years, it has overcome many limitations to become the success it is today. The procedure has improved as well as saved the lives of millions of people worldwide. It basically involves a surgical operation where a damaged or failing organ such as kidney, heart, or lung in the human body is removed and replaced with a functioning one. The organ that is donated can be from a living donor, deceased donor, or an animal. An important area in the field is transplant diagnostics, which is nothing, but tests that are conducted before and after transplant procedures to check the compatibility between the donor and recipient of an organ as well as its suitability in the body. It also involves safety testing and transplant feasibility testing. The aim of the tests is to reduce the risk of organ rejection that can occur owing to incompatible donors. Post-transplant, several diagnostics tests are carried out to check the chances of organ rejection.

Today, transplant diagnostics is a growing market. This growth is attributed to the rise in the incidence of chronic diseases globally, growing geriatric population, technological advancements in transplant diagnostics, and increased R&D activities taking place in the field. Nonetheless, a lack of awareness of an organ shortage for transplant procedures is hindering the market growth. As per the report published by Allied Market Research, the transplant diagnostics market is expected to accrue a sum of $1,031 million by 2022, growing at a CAGR of 10% during the forecast period, 2018-2022.

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Players in the transplant diagnostics industry are focusing on launching innovative and advanced transplant diagnostic solutions which are in line with the needs and demands of customers. For instance, in June 2018, Natera, Inc., a leader in cell-free DNA analysis recently launched a novel kidney transplant rejection biomarker that allows for detecting acute rejection in patients undergoing kidney transplants. In May 2018, numares AG, a German medical technology maker, initiated a pan-European study of AXINON renalTX-SCORE on kidney allograft rejection. In April 2018, CareDx, Inc., a molecular diagnostics company focused on the manufacturing of clinically differentiated, high-value diagnostic solutions for transplant patients introduced its product, HeartCare which is a comprehensive rejection surveillance solution for heart transplant recipients.

Manufacturers in the industry are also focusing on the research and development of transplant diagnostic products through marketing strategies such as mergers and acquisitions. For instance, in January 2018, Siemens Healthineers, a separately managed healthcare business of Siemens AG completed its acquisition of Fast Track Diagnostics (FTD). In 2017, Thermo Fisher Scientific, an American multinational biotechnology product development company acquired Linkage Biosciences, a molecular diagnostics company.

Natera Introduces Kidney Transplant Rejection Biomarker
Natera, Inc. launched a kidney transplant rejection biomarker by partnering with the University of California. The multiplexed PCR (mmPCR) technology enables the detection of acute rejection in kidney transplant patients. In the study, the company used its SNP (Single Nucleotide Polymorphism) technology to measure donor-derived cell-free DNA levels (dd-cfDNA) in 300 plasma samples from 193 unique kidney transplant patients, including 52 patients witnessing acute rejection. The assay was developed based on years of experience in differentiating maternal DNA from fetal DNA in reproductive health. Natera's dd-cfDNA assay showed 92% sensitivity in detecting acute rejection, identifying 48 out of 52 affected cases based on a cutoff of 1% dd-cfDNA. This suggests the potential of Natera's assay for use in both rule-in and rule-out applications.
numares AG Initiates pan-European study of AXINON renalTX-SCORE

numares AG recently announced the commencement of PARASOL, a European multicenter study to continue developing the clinical case from the results of the UMBRELLA study. A non-invasive, urine-based CE-marked in-vitro diagnostic test (IVD), AXINON renalTX-SCORE helps in the diagnosis of kidney transplant rejection. It is the first test available globally to analyze a metabolic constellation rather than single biomarkers for the diagnosis of an acute rejection post-transplantation. “AXINON renalTX-SCORE has the potential to support a physician’s diagnosis and therefore to reduce the number of unnecessary biopsies,” said Volker Pfahlert, chairman of the executive board of numares AG.

Siemens Healthineers Acquires Fast Track Diagnostics (FTD)

Siemens Healthineers completed its acquisition of Fast Track Diagnostics (FTD) with the aim of expanding its molecular diagnostics portfolio and underscoring the company’s commitment to this designated growth area. FTD’s range of CE-marked1 infectious disease detection tests and syndromic panels expands the Siemens’ menu of assays for its VERSANT kPCR Molecular System1 by over 85 assays and syndromic panels. This transforms care delivery for its customers with a comprehensive solution for molecular testing of infectious diseases such as infections of the immunosuppressed, respiratory infections, gastroenteritis, and more. Moreover, FTD’s platform-agnostic menu enables Siemens to serve a wider customer base.

Thermo Fisher Scientific Acquires Linkage Biosciences
Thermo Fisher Scientific acquired Linkage Bio in 2017 for an undisclosed amount, which became a part of former’s transplant diagnostics business, One Lambda. Based in California, Linkage involves in the manufacturing and marketing of molecular diagnostic technologies for complex genetic testing. Its flagship product line is LinkSeq, a real-time PCR genotyping technology. Linkage offers HLA-typing kits, KIR-typing kits, HPA-typing kits, instruments such as liquid handler kit instruments, and accessories. According to Parisa Khosropour, president of Thermo Fisher's the acquisition allows its business to serve more than 1,000 transplant centers across more than 60 countries. The acquisition also brings many benefits such as a broader and deeper range of products, a continued commitment to innovation, and expanded support globally.

Author's Bio: 

I am Srushti Helwande . My keen interest in reading and writing. I forayed into the field of writing due to my love for words and the urge to do something different. I have been a part of the content resource team here in Allied Market Research. We have a dedicated team for content development wherein, we coordinate with the Market Analysts and create a precise content. I am personally involved in writing content for user engagement. I owe a responsibility to make sure the content is rich and user-centric. Allied Market Research has given me the chance to gain knowledge about different subjects.