ALLENEX AB Annual Report 2014
Contents
Allenex at a glance
ALLENEX ANNUAL REPORT
The year in brief 3
CEO commentary 4
About Allenex 6
Right donor for the right recipient 8
Transplantation diagnostics
- a valuable, global niche market 12
World leading products for
a variety of customer needs 16
In close dialog with the market 18
The Allenex share 20
ANNUAL AND CONSOLIDATED ACCOUNTS
Board of Directors' report 21
Financial overview, Group 26
Financial statements 27
Notes 36
Audit report 52
CORPORATE GOVERNANCE
Corporate Governance Report 54
ALLENEX
Board of Directors 60
Executive Management 61
Glossary 62
Contact information 64
Cover: A schematic image of a double helix, the structure in which our DNA is stored. Illustration: Rimantas Vai�ciulis
Allenex is a life science company that develops, manufactures, markets and sells high quality diagnostic products to the global market. Customers comprise medical centers and laboratories active in the transplantation of blood stem cells and organs. The products facilitate efficient matching of donors and recipients prior to transplantation. The company's core market is Europe, followed by the U.S.as the second largest market.
Allenex is based in Stockholm. Sales are conducted through pro-
prietary sales companies in Vienna, Austria, and West Chester, PA, USA, as well as through sub-distributors in close to forty countries. The company was listed in December 2006and the share is
traded on NASDAQStockholm.
ANNUAL GENERAL MEETING
The Annual General Meeting will be held at the IHMBusiness School, Warfvinges väg 39, Stockholm at 4pm on May 20, 2015. Shareholders who wish to have matters addressed at the meeting should submit their proposals in writing to the company at the following address: Allenex AB(publ), Attn: Annual General Meeting
2015, Box12283, 102 27 Stockholm, Sweden or via e-mail to arsstam-
ma@allenex.se. All proposals must be received by the company by April 10, 2015at the latest, or in sufficient time to guarantee that their proposal, if so required, may be included in the AGMnotice. To be entitled to participate in and vote at the AGM, share-
holders must be recorded in the register of shareholders held by Euroclear Sweden on the record day, May 13, 2015. Furthermore, shareholders must register their intent to participate in the AGMin the manner specified in the notice by 4pm on May 15, 2015.
Shareholders whose shares are nominee registered must have their shares temporarily registered in their names by their custodian in good time prior to this date to be entitled to participate in the AGM.
REPORT DATES 2015
Interim report January-March: May 20, 2015
Interim report January-June: August 27, 2015
Interim report January-September: November 26, 2015
FINANCIAL INFORMATION
Allenex financial reports are available in Swedish and English and can be downloaded from www.allenex.se. Reports can also be ordered by e-mail at info@allenex.se.
Contact: Anders Karlsson, CEO, tel. +46 (0)70-918 00 10,
e-mail anders.karlsson@allenex.se or Yvonne Axelsson, CFO, tel. +46 (0)8 50 89 39 72, e-mail yvonne.axelsson@allenex.se.
1998
Allenex is established under the name LinkMed to invest in early stage life science-related operations.
2006
Allenex is listed on
NASDAQ Stockholm.
2008
Acquires Olerup SSP AB, a company focused on trans- plantation diagnostics.
2009
Increases holdings in AbSorber AB, also focused on transplantation diagnostics, to
98%. Establishes an international sales and distribution organization for products in transplantation diagnostics.
2010
Changes strategic direction to
focus completely on transplantation diagnostics.
Year in brief
Consolidated net sales for the year amounted to SEK 125.2million
(111.8), corresponding to an increase of12 percent compared to
2013. Consolidated operating profit for the year wasSEK 22.9 million(9.6). The results include realized and unrealized currency effects ofSEK 6.1 million(-1.9).
QUARTERLY SALES•2012 •2013 •2014
Million
150
120
12 %*
KEY FIGURES, GROUP 90
2014 2013 2012
Net sales, MSEK 125.2 111.8 112.7 60
Operating profit, MSEK 22.9 9.6 7.9
Equity per share, SEK 1.83 1.79 1.80 30
Equity/Assets ratio, % 63 63 63
Number of employees at year-end 55 55 54
0
Q1
Q2 Q3
Q4 Total
*Change from previous year, % Source: Allenex
GENDER DISTRIBUTION, GROUP
SALES PERFORMANCE 2012-2014
Million
150
120
90
60
30
125.2
MSEK
0
2012
2013
2014
•Women 65% ( 36 total) •Men 35% ( 19 total)
•Total •Europe and the rest of the world •North and South America
Source: Allenex
Significant events during the year
• Shares in Allenex previously owned directly by the company's largest shareholder, Mohammed Al Amoudi, have been transferred to Midroc Invest AB, a company wholly-owned
by Mohammed Al Amoudi. Mohammed Al Amoudi's shares in Xenella Holding AB( jointly owned by FastPartner AB) were also transferred to Midroc Invest AB.
• Allenex has extended and expanded its collaboration with its partner Conexio Genomics and is launching three new products from Conexio globally.
• Allenex has begun developing a new technology for HLAtyping based on Real Time PCRtechnology. The new product is expected be launched in 2015.
2011
Enters into an exclusive sales and dis- tribution contract with the Australian company Conexio Genomics. Changes company name to Allenex AB.
2012
Completes the refocus of Al- lenex operations to transplan- tation diagnostics.
2013
Completes divestment of the previ- ous portfolio of associated compa- nies in life science.
2014
Extends and expands collaboration with Conexio Genomics.
ALLENEX ANNUAL REPORT 2014 OPER ATIONS 3
CEO commentary
A LOOK BACK AT 2014 ...
In 2014, our sales efforts yielded good returns and we have taken key initiatives to broaden our product portfolio. We took anoth- er step towards achieving our financial objectives and laid the foundation for continued favorable developments going forward.
We maintained our strong position in Europe in HLAtyping, based on our core product, Olerup SSP®, at the same time as we saw strong sales growth in the U.S., from the typing kit from our Australian partner Conexio Genomics. We have gradually been solidifying our position as a supplier to major transplantation laboratories in the U.S. Positive currency trends for Allenex also contributed to solid sales growth during the year.
It is also gratifying to see increased demand for our cross- match test for non-HLAantibodies. This reinforces our assess- ment that this test has a key place in our product portfolio.
Product development and R&Dwork play a central role in our ability to maintain our position as a leading supplier of test kits for HLA typing. Furthermore, our ability to systematically update our products on a quarterly basis, as new HLAalleles are identified, contributes to keeping us on the cutting edge in terms of product offering. In line with this, we ourselves began a major develop- ment project with the aim of launching typing tests based on Real Time PCRon the global market in 2015, a method that is both simpler and faster compared to typing methods used today.
We have also put a lot of hard work and effort into expanding and strengthening our relationship with our partner, Conexio Genomics of Australia. Our contract with Conexio has been ex- tended to April 2018, giving us three new products from Conex- io, including ones in the Next Generation Sequencing segment. Consequently, we are now broadening our product portfolio and strengthening our position as a supplier of diagnostic products with highly innovative content.
During the year, we continued to develop our network of local distributors. We also carried on our work to register our products on new markets. Internally, we continued to trim our operations, improve our processes and increase our margins during the year.
On a management level, while two members of our team left the company, we have advantageously been able to recruit
replacements. In our experience, Allenex is seen as an exciting company with advanced products on a global market, while
at the same time offering the benefits that come with a small company, such as transparency and short decision-making paths. Going forward, it is our belief that we will continue to forge ties with the expertise that is required for the further development of our operations. Indeed, we were delighted to come in at first
place on the 2014AllBright list of listed companies with the most gender-equal management teams.
Sales during the year were up 12percent. We had an EBITmargin of 18percent in 2014as a whole, with strong perfor- mance in the second half of the year. The company's operating margin for the third quarter was 22percent and 31percent in the fourth quarter.
2015 AND ONWARDS …
By developing diagnostic tests based on Real Time PCRmethod- ology, we are laying the foundation for a new product platform, providing us with a starting point for continued development work. In this way, it is vital that we shift our focus to areas where we see future growth potential.
With new products, including ones in Next Generation Sequencing, we will be well positioned. During 2015, we will also continue our efforts to find additional partners with complementary products. The opportunity to maximize our sales organization in this way is an important factor in further strengthening our margins and maintaining continued revenue growth. Another key factor in maintaining our strong position in Europe is successful participation in the centralized procure- ment processes that have become more and more common in recent years.
At the same time, it is important for us to defend our market position both in Europe and the U.S.We now have a strong net- work of distributors that also provides us with the opportunity to cultivate markets outside Europe and North America. Among these is the Middle East, where we currently see an increase in demand for HLAtyping products. In many countries, product registration is bureaucratic and time consuming but we continue to press ahead to get through the process as quickly as possible.
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ALLENEX ANNUAL REPORT 2014
» In 2014, our sales efforts yielded good returns and we have taken important initiatives to broaden our product portfolio. «
FINANCIAL OBJECTIVES
• Sales growth
• EBIT margin
%
25
Sales growth target
Operating margin target
20
15
10
5
0
-5
2011*
2012
2013
2014
* Olerup GmbH is included from June 1, 2011
Source: Allenex
The emergence of new technologies like Next Generation Sequencing and Real Time PCRwill certainly change market conditions - but at what pace is still uncertain. The competitive environment is also in a state of change, now that the U.S.-based Thermo Fisher Scientific has acquired our competitors Life Tech- nologies and One Lambda. There is no doubt that the integration of these companies will create a powerful group with significant resources. For Allenex as a competitor, this means that we must actively pioneer our own way forward.
The acquisition in early 2015of minority interests in our subsidiaries provides us with a better structure and increases our opportunities to streamline operations. Furthermore, we will retain within the company the dividends previously distributed to the minority shareholder, which will be significant in view of expected future developments.
The good outcome that we saw in 2014, which lays a solid foundation for 2015, could not have been achieved without all the efforts of employees and distributors - for which I would like to express my great appreciation.
Anders Karlsson CEO
ALLENEX ANNUAL REPORT 2014 OPER ATIONS 5
About Allenex
Allenex ABwas listed in December 2006under the n me LinkMed ABand the share is traded on NASDAQStockholm. In 2011, the company changed name to llenex AB. Since 2012, Allenex has been completely focused on the transplantation diagnostics sector. The company serves a global market with a customer base comprising medical centers and laboratories active in the transplantation of blood stems cells and organs. The products facilitate efficient matching o donors and recipients prior to transplantation. The company's main market is Europe, followed by the Aas the second biggest market. Allenex is based
in Stockholm, with sales conducted through proprietary sales companies in Vienna, Austria, and West
Chester, PA, USA, as well as through sub-distributors in close to forty countries.
BUSINESS CONCEPT
Allenex is a life science company that develops, manufactures, markets and sells high quality products that facilitate safer trans- plantation of blood stem cells and organs on the global market.
VISION AND LONG-TERM OBJECTIVES
Focusing on growth and profitability, Allenex strives to be a leading global player in the transplantation diagnostics sector. With a broad product portfolio for diagnostics and matching in hematopoietic stem cell and organ transplantation, the company seeks to offer a complementary range of products that increases the likelihood of successful transplantation. Allenex aims for its products to be the first choice of hospitals, medical centers and laboratories.
BUSINESS MODEL
Allenex sells its products to medical centers and laboratories active in the transplantation sector. The majority of sales com- prise products developed and manufactured by Allenex, however the company also offers complementary products from other companies. Sales of test kits for diagnostics and matching are the company's main source of income. Sales are carried out in part through the company's own sales organization to end customers and in part through local distributors.
A key value-driving factor is the knowhow to continually update the product range in order to incorporate new genetic knowledge that the company gathers on an ongoing basis. Anoth- er is the company's ability to maintain close contact with medical centers and institutions that lead development in the transplan- tation sector, thereby enabling Allenex to optimally focus the further development of new and existing products. Customers
are highly specialized and technologically skilled, which is why the ability to use this valuable knowledge and expertise in product de- velopment creates value for all parties. A high level of service and reliable delivery also contributes to value creation.
FINANCIAL OBJECTIVES
Allenex financial objectives are to increase consolidated sales in one economic cycle by an average of at least 10percent per year, with an EBIToperating margin that exceeds 20percent.
ORGANISATION & EMPLOYEES
Allenex is headquartered in Stadshagen, Stockholm, where the company's Economy &Finance, Research &Development, Pro- duction, Quality Assurance and Regulatory Affairs functions are located, as well as Marketing and Communications. Allenex has a flat, functional organizational structure, in which the head of each function reports directly to the CEO. The managers of the com- pany's sales organizations in Vienna, Austria, and in West Chester, PA, USAalso report directly to the CEO.
The company's in-house developed test kits are manufactured, packaged and stored at the company's premises in Stadshagen, Stockholm. Here, the final packaging of products that Allenex markets and sells on a contract basis for the Australian compa-
ny Conexio Genomics is also completed. Furthermore, some warehousing of products is carried out at the sales office in the U.S.The products are temperature-sensitive and are therefore kept in cold storage and in some cases are shipped by refrigerated transport. In Stockholm, the premises also houses laboratories for research and product development.
At the year-end 2014, the number of employees in the group was 55 (55). Of these 37 (37),were employed in Sweden, 8 (8)
in the U.S.and 10 (10)in Austria. During the year, the company workforce consisted of 65 percent (67)women and 35percent (33)men. The company's products are advanced and subject to significant regulation, putting high demands on expertise and
experience. Of the 55 employees in the group, 7 (13 %)have PhDs/
research degrees.
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ALLENEX ANNUAL REPORT 2014
PRODUCTION FLOW
1 All primer mixers for each specific product and batch are designed, tested and quality con- trolled at the laboratory, after which they are released to production.
2Primary mixers are prepared in deepwell plates, prior to being dispensed in PCRplates.
3Deepwell plates are placed in the dispensing robot, which automati- cally and simultaneously dispenses all the differ- ent primer mixers from the deepwell plate to the desired number of PCRplates.
4After dispensation, the PCRplates are dried and sealed, and undergo visual inspection.
5Approved PCRplates are packed in inner boxes. Following QCrelease they are packed with other materials in outer boxes ready for delivery.
EMPLOYEES
BEN PASSEY GUSTAF OLSSON ANNIKA STAVSJÖ
Ben started in August 2014and has a background in genetic research. He has previously worked in a number of com- panies in the diagnostics field, such as Qiagen, Life Technologies, Dynal Biotech and Biofortuna. He is now managing the development of the new Real Time PCRproduct.
'I wanted to come back to the trans- plantation field and knew about Olerup SSP. The move to Stockholm from
England went very smoothly with the help of the company. I appreciate the good facilities and my very positive colleagues. I hope to be able lend support to the devel- opment of new products.'
Gustaf has been working at the company since 2005, first in production and then with stock and delivery, an area which he is in charge of today.
'The journey from family company to the company we are today has been an exciting one. It is fun to have your own area of responsibility. With customers all over the world, there are new challenges every day. It also requires us to constantly enhance our procedures and processes.'
Annika started working at Allenex in May 2013. Prior to joining the company she worked at the Swedish branch of the pharmaceutical company Glaxo Smith Kline. Annika brings with her 23years of
experience in IT,logistics, business control and business development. Today, she works with internal monitoring and re- porting, as well as with the development of processes and systems support in order to better monitor operations.
'It is exciting to move from a major corporation to a company the size of Al- lenex. Here one can work all the verticals and horizontals of the company, not least close to production. I like having good procedures in place that create order. There is also something very positive about products that contain a human di- mension and that mean a lot to so many.'
ALLENEX ANNUAL REPORT 2014 OPER ATIONS 7
Right donor for the right recipient
Stem cell and organ transplantation is now an established form of treatment for a variety of medical conditions. The number of transplants continues to grow and from a socio-economic perspective transplantation is a very profitable treatment, whi h enhances the quality of life and increases the working capacity of the patient. Each individual h s a unique set of HLAantigens that initiate reac- tions in the body's immune system. A successful transplant depends on careful matching of the donor and the recipient, making sure the differences in t eir immune systems are as slight as possible.
TRANSPLANTATION OF BLOODSTEM CELLS AND ORGANS
In stem cell transplantation, new healthy blood stem cells are transmitted to the body. The transplanted cells may be the pa- tient's own stem cells (autologous transplantation) or cells from a donor (allogeneic transplantation). The new blood-forming stem cells have the ability to build up and sustain new bone marrow in the recipient, which can then form all types of blood cells. Before, stem cell transplantation was termed bone marrow transplanta- tion, as bone marrow was previously the most common source
of blood-forming cells. Nowadays, stem cells are either sourced directly from the donor's blood or from blood remaining in the umbilical cord after birth.
Hematopoietic stem cell transplantation (HSCT )may be the best or perhaps the only possible treatment for severe blood dis- eases, especially leukemia and lymphoma, life-threatening anemia, and a variety of rare metabolic diseases. The list of diseases that can be treated with HSCT is growing steadily. The treatment of non-hematological indications (including psoriasis, multiple scle- rosis, scleroderma, and diabetes) has also started, albeit to a limit- ed extent, which increases the patient population significantly.
In an autologous transplantation there is no donor involved, which means there is no risk for an immunological reaction. In al-
logeneic transplantation, however, stem cells from another person are used, meaning that the success of the transplant depends on finding the best possible donor and recipient match so that the differences in their immune systems are as slight as possible.
AUTOLOGOUS OR ALLOGENEIC TRANSPLANTATION The type of disease determines whether autologous or allogeneic transplantation is used. In certain diseases, treating the diseased cancer cells with chemotherapy
also destroys the blood-forming cells in the bone marrow
to such an extent that it would take a very long time to restore them without new stem cells. Here, the patient's own (autologous) blood-forming stem cells are cultivated and reintroduced after chemotherapy. For other diseases, the problem is directly associated with blood stem cells, which therefore must be replaced with new ones (alloge- neic) from a healthy donor.
Updated figures on the number of global stem cell transplants are lacking. According to the U.S.-based National Marrow Donor Program approximately 6,300allogeneic hematopoietic stem
Stem cell transplantation in the U.S.
Organ transplantation globally
Autologous
Allogeneic with non-related donors
Kidney
Liver Heart
Allogeneic with related donors
Thousand
14
12
10
8
6
4
2
0
Lungs
Thousand
80
70
60
50
40
30
20
10
0
Pancreas
Source: Center for International Blood & Marrow Transplant Research
*Incomplete data
Source: WHO, Global Observatory on Organ Donation and Transplantation
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ALLENEX ANNUAL REPORT 2014
transplants were performed in 2013in the U.S. The vast majority of these occurred between unrelated individuals. In Sweden, approximately 253allogeneic transplants were performed in 2013.
»From a socio-economic perspective, transplantation is a very profitable treatment «
Organ transplantation is an established form of treatment when a person's organ does not function as it should. This may be due to a chronic disease such as diabetes, which is the most common reason for a kidney transplant, or acute conditions, such as poi- soning. Organs donated for transplantation are primarily kidneys, hearts, lungs, livers and pancreases. Progress in the matching of donors and recipients, surgical techniques and postoperative
treatment with immunosuppressants is facilitating more and more transplants.
According to WHO(Global Observatory on Donation and Transplantation) around 115,000organ transplants were per- formed globally during 2012, an increase of 1.8percent compared to the year before. The U.S. is by far the largest market globally, with Germany as the largest market in Europe. While donating blood stem cells is relatively simple and new donors are coming forward all the time, growth in organ transplantation is inhibited in particular due to a shortage of organs. The waiting period for patients who need a new organ is very long in many countries. Different factors lie behind the shortage of organs, not least ones that are of an ethical, cultural or religious nature.
Most transplant patients experience some type of complica- tion during the first few weeks after surgery. A common reason is that the immune system reacts against the foreign organ or
foreign blood stem cells since the body recognizes the transplant
HOW HLA MATCHING IS DONE
T A
G C
1. Donor & Recipient
2. Blood test 3. DNA extraction
4. HLA typing
5. Analysis & Matching
A T
C HLA-A*02:01, 66:02
G HLA-B*07:02, 51:01
HLA-DRB1*13:01, 14:02
1 DONORS AND RECIPIENTS
HLA are proteins that are found on most cells in the body. The immune system usesHLA markers to determine which cells are endogenous
and non-endogenous. Following a transplant, the aim is to avoid strong reactions from the immune system to the non-endogenous markers.
For that reason, HLAinformation is used to match the donor and reci- pient prior to a transplant. An HLAmatching is a test of the number of markers that the donor and recipient have in common with each other,
the more markers that match, the better the match.
3 DNA EXTRACTION
In genomic typing information is sought from the person's DNA.
To be able to 'read' this information, the DNAis first extracted from the cell nucleus and the cell and washed of any residue. The result is a sample of pure DNA.
4 HLA TYPING
Examples of methods for HLAtyping (determination) are PCR-SSP, SBT, SSOand NGS.
2 BLOOD TEST
Blood samples are taken for HLAmatching. Both SSPand SBTtech- nology are examples of genomic methods for HLAtyping. The blood sample contains nucleated cells, with DNA, the genetic material, found in the cell nuclei.
5 ANALYSIS AND MATCHING
Each sample is typed by analyzing the genomic data describing the
HLA markers. The more markers that match between the two samples, the betterHLA matching.
HLA matching is only one of the various parameters that form the basis for decision-making in the area of transplantation between a recipient and a given donor. The criteria also differs depending on what is being transplanted and if the donor and recipient are related or not.
ALLENEX ANNUAL REPORT 2014 OPER ATIONS 9
as 'non-self.' In order to avoid rejection reactions the recipient
is given immunosuppressive therapy after the transplant, a treat- ment that can cause side effects, however. A well-implemented matching of donor and recipient is thus an important step in reducing the extent of the complications.
In stem cell transplantation, there is a risk that the new blood stem cells may attack their new host (recipient). This is called 'graft-versus-host-disease (GvHD),' which can be acute or occur at a later stage after the transplantation.
THE MATCHING PROCESS
Matching involves pairing a donor with a recipient, taking into account a number of factors that may influence the outcome
of the transplantation. Matching is done to facilitate a success- ful transplantation. A good match, reduces the risk of rejection reactions and increases the likelihood that the new blood stem cells or organ will be able to function as intended with minimal medication.
» A good match reduces the risk for rejection «
In the first instance, efforts are made to find a living donor within the patient's family, as there is greater probability of finding a good match for the recipient. If this does not work, hospitals normally contact a donation register in the case of a stem cell do- nation to find a potential donor. Organs that cannot be sourced from a family member are usually donated via a deceased donor. When a deceased person is accepted as an organ donor, suitable recipients are selected from available waiting lists.
ONE IN FOUR CHANCE
There is a one in four chance of finding a stem cell donor within the patient's family. Every cell in the body has a double set of HLAmolecules, one from the mother and one from the father. There are therefore four pos- sible combinations, which means that on average every fourth sibling has the same HLAtype.
Prior to transplantation, an immunological evaluation is carried out to determine the potential of matching a donor and a recipient. Important elements of the evaluation include HLAtyping and different types of crossmatch tests. The evaluation process depends on the patient's disease and if the donor is related or unrelated. In the case of living donor, the matching process can be carried out at an early stage of the evaluation.
In order to have access to suitable blood stem cell donors, spe- cial registers of voluntary donors who are willing to donate bone marrow or hematopoietic stem cells have been built up. Poten- tial donors are HLAtyped for these registers. Prior to transplant
surgery, the transplantation laboratory orders samples from these
records to compare with the recipient patient.
HLA TYPING
The HLAsystem plays an important role in transplantation as dif- ferences in HLAmakeup may lead to rejection of the transplanted organ/stem cells. In stem cell transplantation, it is essential that the donor's and recipient's set of HLAantigens are as similar as possible. This is also an advantage in organ transplantation.
THE NUMBER OF DETECTED ALLELES
Thousand
NUMBER OF DONORS IN BLOOD STEM CELL REGISTERS*
Million
15 25
24.7
12.5
12 20
9 15
6 10
3 5
0 0
Source: IMGT Database
* Encompasses registers connected to BMDW
Source: Bone Marrow Donors Worldwide
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ALLENEX ANNUAL REPORT 2014
HLA SYSTEM
Most cells in the body contain proteins called HLA(Human Leukocyte Antigens) in their cell membranes. These proteins play an important role in alerting the immune system to the presence of foreign fragments (antigens), from for example viruses, bacteria or foreign cells in the case of transplantation. They also identify any of their own cells that for one reason or another have mutated or otherwise altered.
For more information see Glossary on page 62.
HLA antigens are the most polymorphic genes in the genome, which means that there is a large variety of different types ofHLA antigens among the general population. Today, more than12,000 differentHLA variants have been identified and new genetic vari- ants (alleles) are identified every day.
HLA TYPING METHODS
The widespread use of DNA-based tissue typing techniques has increased the accuracy and specificity of HLAtyping. This allows more precise HLAmatching between the donor and recipient and provides:
• Better rate of survival following stem cell transplantation.
• Reduction in the incidence and severity of transplant related complications.
• Improved engraftment (which means that the recipient's body accepts or adapts to the transplanted material), as well as lower risk that the new stem cells will attack the host.
Today, there are three common HLAtyping methods:
• Sequence Specific Primers (SSP)
• Sequence Based Typing (SBT)
• Sequence Specific Oligonucleotides (SSO)
The SSPmethod (see Glossary on page 62) is expedient, enabling high resolution of an individual's HLAtype. It is used by most transplantation immunology laboratories worldwide. This is a manual technique, and therefore suitable as a primary typing tech- nique for laboratories that do not have an overly high throughput of tests. The SSPmethod is also used as a secondary testing meth- od at laboratories with a high throughput of samples, and is used, for example, to confirm typing done with an automated method, or as a method used for typing during on-call duty when staffing
is often limited and a test result is needed quickly. The SSPmeth- od has a number of advantages:
• The technology is simple to learn and easy for a laboratory to get started with, and does not involve high start-up costs.
• It provides fast, accurate results with a high level of resolution.
• It is the fastest method for HLAtyping.
• It is best suited for investigating sequence differences beyond the commonly studied parts of HLAgenes.
The SBTmethod (See Glossary on page 62) is the newest of the three commonly used methods and is an automated technology, which means that large quantities of tests can be run at the same time. The method is therefore suitable for high-volume labora- tories. The SBTmethod is primarily used when high resolution is important, such as in the case of stem cell transplantation. In addi- tion to HLAtyping, SBTis used in infection diagnostics and genet- ic research. SBTtechnology is characterized by the following:
• It is more reliable than other technologies.
• New alleles can be detected relatively easily.
• It is also the most automated technology.
• However, the required equipment is much more expensive than for example SSP.
The SSOmethod (See Glossary on page 62) is often used when a low or medium resolution is required. The method can be auto- mated and used to advantage when a large number of samples are being tested. The disadvantage of this method is that it does not provide the same high resolution as the two other methods.
CROSSMATCH TESTING
A crossmatch test in organ transplantation is carried out to detect on the spot if the recipient has antibodies against the tissue of the intended donor. A fresh blood sample from the recipient is tested directly against donor cells just before transplantation.
The antibodies being tested for either target HLA(lympho- cytes, antibodies that target white blood cells) or non-HLA(cer- tain antibodies targeting endothelial cells). Endothelial cells coat the inside of blood vessels and recent research has shown that the presence of such antibodies increases the risk of rejection.
ALLENEX PRODUCTS FOR MATCHING
Allenex is a leading company for SSPbased products for HLAtyping and also offers SBTbased products through a collabora- tion with the Australian company Conexio Genomics. Allenex is furthermore the only producer of crossmatch tests targeting
endothelial cells (non-HLA). Read more about the Allenex product portfolio on Page 16.
ALLENEX ANNUAL REPORT 2014 OPER ATIONS 11
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