News from Linkage Biosciences

Linkage Biosciences Awarded Four-Year Contract by the UK’s NHS Blood and Transplant

SAN FRANCISCO, California, August 29, 2016 ─ Linkage Biosciences, a global leader in the field of transplant diagnostics, announced today that it has been awarded a four-year contract by NHS Blood and Transplant (NHSBT) in the UK for implementation of the LinkSēq™ Real-Time PCR HLA typing product.  The new tissue typing platform, including Real-Time PCR instrumentation, will be installed and adopted by various laboratories across the country.

Dr. Andrea Harmer, National Head of NHS Blood and Transplant H&I Services, said, “At NHS Blood and Transplant, we were looking for the best technology available for our rapid typing requirements. We developed a comprehensive matrix to evaluate multiple platforms and were extremely pleased with the results from Linkage Biosciences.  The laboratory tests performed by our scientists showed the product to be simple to use, fast, and robust.”

“We are excited to partner with NHS Blood and Transplant and support the fast-growing adoption of LinkSēq tissue typing technology,” said Zachary Antovich, Chief Executive Officer of Linkage Biosciences.  “The technical advantages of LinkSēq, as supported by all the necessary evidence during the evaluation period, clearly established the superiority of our offering.  The decision of the UK’s NHS Blood and Transplant to select our product is the outcome of a thorough evaluation of the competitive landscape and we suspect other nations will view this tender as a benchmark for their own assessment.”

LinkSēq offers a dramatically simplified workflow for detecting Human Leukocyte Antigen (HLA) genes associated with tissue compatibility for organ transplantation.  With less than 10 minutes of set-up and no further operator intervention, LinkSēq provides complete molecular genotyping results in as little as 90 minutes.  Its simple workflow avoids post-amplification contamination, as well as allowing rapid turnaround time and increased laboratory productivity.

Since its introduction in 2011, LinkSēq technology has been adopted by more than 140 laboratories across four continents.  The company received regulatory approval in Europe in 2015.

 About NHS Blood and Transplant

NHS Blood and Transplant is a joint England and Wales Special Health Authority.  It is responsible for ensuring a safe and efficient supply of blood and associated services to the NHS in England.  It is also the organ donation organization for the UK and is responsible for matching and allocating donated organs.

Linkage Biosciences Announces CE Mark for Real-Time PCR HLA Tests

SAN FRANCISCO, California, June 9, 2015 ─ Linkage Biosciences, a global leader in the field of transplant diagnostics, announced today that the LinkSēq™ Human Leukocyte Antigen (HLA) test is now available with CE Mark. LinkSēq can be used in Europe for In Vitro Diagnostics (IVD) applications in the fields of solid organ and stem cell transplantation.

LinkSēq is the first commercially available HLA testing platform developed for use with Real-Time PCR instrumentation that allows the identification of all classical HLA genes in a single test. For the more than 70,0001 patients waiting for organ transplants in Europe, rapid and reliable organ and tissue testing is critical.

“European regulatory approval represents an important milestone in Linkage Biosciences’ ongoing commitment to provide fast and accurate diagnostic products for the transplant community,” said Zachary Antovich, CEO of Linkage Biosciences. “For over a decade Linkage has focused on innovation and quality and so we are pleased to be operating according to the highest international standards.”

The CE Mark was certified by LNE/GMED, the sole French accredited Notified Body for the European IVD Directive. Additionally, the company’s Quality Management System was certified to ISO 13485 standards for the design, development, manufacture, and distribution of the LinkSēq products.

About Linkage Biosciences

Linkage Biosciences is a molecular diagnostics company developing and marketing products that dramatically improve and expedite complex genetic testing. LinkSēq is the company’s flagship technology that provides the fastest and simplest method of Human Leukocyte Antigen (HLA) testing on the market, covering all classical HLA genes and over 12,000 alleles in a single test.   LinkSēq technology utilizes a proprietary assay methodology including reagents and software in combination with standard Real-Time PCR hardware to simplify the determination of complex genetic sequences. The company is headquartered in South San Francisco, California. To learn more please visit www.linkagebio.com

1Council of Europe European Committee on Organ Transplantation, International figures on organ, tissue & hematopoietic stem cell donation & transplantation activities (September 2014 newsletter):

https://www.edqm.eu/medias/fichiers/newsletter_transplant_vol_19_no_1_september_2014.pdf

Copyright 2015.  Linkage Biosciences, Inc.  All rights reserved.

Linkage Biosciences and LinkSēq are trademarks of Linkage Biosciences, Inc.

Linkage Biosciences Partners with Italian Distributor

SAN FRANCISCO, California, April 27, 2015 ─ Linkage Biosciences announced at the 29th European Immunogenetics and Histocompatibility Conference in Geneva, Switzerland a new distribution partnership with Voden Medical Instruments S.p.a. With a highly experienced leadership team, Voden Medical Instruments has a history of delivering the best quality and most advanced technologies to their customers. This new distribution partnership represents another step forward in providing LinkSēq HLA typing technology to customers around the world. “Voden Medical possesses a long standing record of excellent customer service and proven technical expertise, particularly in the area of HLA testing,” said Zachary Antovich, CEO of Linkage Biosciences. “We are looking forward to partnering with Voden to provide LinkSēq HLA typing technology throughout Italy.”

To learn more about Voden Medical Instruments S.p.a., please visit www.vodenmedical.com

Linkage Biosciences Opens European Subsidiary

SAN FRANCISCO, California, April 16, 2015 ─ Linkage Biosciences announced the launch of a wholly owned European subsidiary located in Geneva, Switzerland. The launch reflects the company’s rapid growth and increasing global demand for LinkSēq™, the world’s fastest and simplest method of molecular tissue typing, allowing the identification of all classical Human Leukocyte Antigen (HLA) genes in a single test.

“Linkage is seeing great success with adoption of LinkSēq by numerous laboratories throughout Europe,” said Linkage Biosciences’ CEO Zachary Antovich. “Our new Swiss operations will extend our global reach and provide superior support and service to customers across the region.”

Linkage’s new office is set within Fongit, one of Geneva’s leading technology clusters, supporting innovative companies in Medtech, IT, and Cleantech industries. Mr. Pierre Maudet, former Mayor of Geneva and now State Councilor in charge of the Department of Security and Economy for the State of Geneva said, “We are delighted Linkage Biosciences has chosen to locate in Switzerland and specifically the Geneva and BioAlps life sciences community. Geneva offers a central location, strong life sciences network, and many benefits to support the growth and adoption of Linkage’s exciting technology.”

The new subsidiary gives Linkage a dedicated presence in the heart of Europe and will support its on-going commercialization efforts as well as provide a foundation for future development.

Linkage Biosciences Announces Expansion

SAN FRANCISCO, California, December 22, 2014 ─ Linkage Biosciences, a leading manufacturer of tissue transplantation diagnostic products, announced a new long-term agreement to add manufacturing, research and development, and office space in South San Francisco, California.

“We’re pleased Linkage Biosciences has chosen to continue to grow in South San Francisco,” said South San Francisco Mayor Richard Garbarino.  “We hope that they will grow in our City for many more years. We take pride in seeing our innovative companies succeed.  Linkage’s technology platform is critical to the future development of medicine and drugs, improving the health of all our residents and people on a global basis.”

“We doubled our staff last year and continue to prepare for more growth,” said Zachary Antovich, CEO of Linkage Biosciences. “This new, custom-designed space will integrate into our manufacturing system and increase our overall production capacity to meet the needs of our expanding customer base.”

Linkage Biosciences Adds to Board Leadership

SAN FRANCISCO, California, November 7, 2014 ─ Linkage Biosciences, a leading manufacturer of tissue transplantation diagnostic products, announced the election of Mr. Lewis J. Stuart to the company’s Board of Directors. The election reflects Linkage’s continued focus on expansion in both domestic and international markets.

Mr. Stuart has more than 30 years of global healthcare commercial experience across multiple sectors including oncology, cardiovascular, and infectious disease. Currently, Mr. Stuart is Vice-President of Sales and Marketing at Genomic Health, Inc., a leader and pioneer in molecular oncology diagnostics.  Prior to Genomic Health, Mr. Stuart served as President and General Manager of Phenogen Sciences, a North American subsidiary of Australia-based, Genetic Technologies, Inc.   Mr. Stuart spent over eight years in several commercial roles at CV Therapeutics, now a division of Gilead Sciences, and has held senior leadership positions at both Pfizer and Bristol Myers Squibb, notably leading the launch of Viracept, a lifesaving treatment for HIV/AIDS.

“Lewis brings an extensive commercial leadership background to the Board at an important time in our development,” said Zachary Antovich, CEO of Linkage Biosciences. “We look forward to benefiting from Lewis’ insights as we execute our growth initiatives.”

Linkage Biosciences Launches Real-Time PCR KIR Test

SAN FRANCISCO, California, December 9, 2013 – Linkage Biosciences announced the launch of the first commercially available real-time PCR KIR genotyping test at the 39th annual meeting of the American Society for Histocompatibility and Immunogenetics (ASHI).  Killer cell immunoglobulin-like receptors (KIR) are a family of cell surface receptors found on human Natural Killer (NK) cells with known associations to autoimmunity, viral progression, tumor immunity, and hematopoietic stem cell transplantation.  Understanding the role of these receptors could have significant clinical implications in the future.  Linkage’s new LinkSēq ™ KIR genotyping test dramatically simplifies laboratory workflows compared to previous KIR typing methods while providing clear and accurate results.

The HLA Laboratory at the City of Hope National Medical Center collaborated on early validation studies with Linkage and the resulting work was selected for presentation at ASHI’s annual meeting.  The laboratory concluded that Linkage’s method was easy to perform and train personnel, and data analysis was simple and quick.

Linkage’s homogeneous test can be run and analyzed on standard real-time PCR instrumentation without needing further analytical techniques required by other tests.  Linkage’s test identifies all the major KIR genes including specific variants in 2DL1, 3DL1, and others.

“The LinkSēq system provides a tremendous advance for molecular KIR typing,” said Zachary Antovich, CEO of Linkage Biosciences.  “We are excited by this latest product launch and look forward to continuing our efforts to enable and accelerate critical immunology research in transplantation and infectious disease.”

Linkage Biosciences Closes Growth Capital and Inks Distribution Partners

SAN FRANCISCO, California, May 7, 2013 – Linkage Biosciences, a molecular diagnostics company and leader in Human Leukocyte Antigen (HLA) typing and associated products, announced that it recently raised $2 million in growth capital. The financing was led by Fisher Capital Corp LLC with all major investors from previous rounds also participating including Greenhouse Capital Partners and Big Sky Partners.

“We are seeing a marked increase in demand for the LinkSēq™ product line,” said Zachary Antovich, the company’s Chief Executive Officer. “Our focus on quality and delivering winning solutions to the HLA community has generated a loyal and passionate user base. This financing will help accelerate our efforts around the world.”

Linkage Bioscience’s LinkSēq HLA product line uses a proprietary software and chemistry platform in conjunction with real-time PCR instrumentation to deliver results faster and simpler than any other system on the market.

In addition to the financing, Linkage announced several new distribution partners including GenDx Products (Benelux countries), Commugene (South Korea), and Ortner Medical Supplies (Austria).

”Each of these companies possesses a history of excellent customer service and proven technical expertise, particularly in the area of HLA testing,” continued Mr. Antovich. “We are looking forward to working with our new partners as we expand into these territories.”

Linkage Biosciences Establishes New Manufacturing Facility

SAN FRANCISCO, California, May 3, 2012 – Linkage Biosciences, a molecular diagnostics company and leader in molecular HLA typing and associated products, has entered a long-term lease arrangement for new manufacturing, lab, and office space in South San Francisco, California. In the heart of the biotechnology corridor in the Bay Area, this facility will become the primary commercial-scale plant for the company’s complete LinkSēq™ product line. The move allows Linkage to continue its growth and expansion in both domestic and international markets.

“This state-of-the-art facility meets our process requirements and provides significantly more production capacity than our previous facility,” said Zachary Antovich, CEO of Linkage Biosciences. “In addition, these new facilities accommodate our expanding R&D, regulatory and administrative needs. This facility is ready to be a part of our ISO 13485 certification and other regulatory efforts including CE and FDA regulatory filings.”

Linkage Biosciences Closes $2.1M in Funding

SAN FRANCISCO, California, September 8, 2011 – Linkage Biosciences, announced that it raised over $2 million in Series B financing. Linkage Bioscience’s LinkSēq™ HLA product line uses a proprietary software and chemistry platform in conjunction with real-time PCR instrumentation. This combination of technologies provides significant improvements in the analysis of complex genetic regions including reducing labor requirements by up to 85% compared to current methods.

Fisher Capital Corp LLC and Greenhouse Capital Partners led the round with all major existing investors from previous rounds participating including Big Sky Partners. “This is an exciting time in the maturation of Linkage Biosciences,” said James R. Fisher Sr., Managing Member of Fisher Capital Corp LLC. “With this financing, the company is now positioned to scale up operations to capitalize upon its revolutionary LinkSēq technology.”

Zachary Antovich, Linkage’s CEO, said the funds will be used to expand manufacturing capabilities, complete regulatory requirements in the US and Europe, and increase the speed to market of additional molecular tests. “Our commercialization plans and technology are progressing rapidly,” said Mr. Antovich. “The strong support from our current investors is the result of our continued success in achieving milestones and delivering products that meet or exceed the expectations of our customers.”

Linkage Biosciences Delivers First Real-Time HLA Testing Kit in Anticipation of New UNOS Requirements

SAN FRANCISCO, California, May 17, 2011 – At the 25th European Immunogenetics and Histocompatibility Conference, Linkage Biosciences, Inc., a privately held, molecular diagnostics company, announced the launch of several new research use only (RUO) products in the LinkSēq™ HLA product line. Working closely with the HLA and life sciences communities, Linkage Biosciences has been aggressively expanding its product development. For example, as of June 1, 2011, new policies are being implemented by United Network for Organ Sharing (UNOS) and The Organ Procurement and Transplantation Network (OPTN) for organ sharing. These policies require that deceased donor HLA typing be performed by DNA methods and identify five HLA antigens (–A, –B, –Cw, –DR and –DQ) before laboratories make any kidney, kidney-pancreas, pancreas, or pancreas islet offers. LinkSēq is the first HLA testing product to apply real-time PCR technology to test for each of these genes. It is the only test to combine DNA amplification and analysis in one step. These design features are intended to make LinkSēq faster and simpler than traditional HLA diagnostics.

Zachary Antovich, President and CEO of Linkage Biosciences, presented data at the conference showing the test can be run in 10 minutes of hands-on time and 90 minutes of total test time. Current methods of HLA typing require approximately two hours or more of hands-on time and three hours or more of total test time.

“Linkage is making steady progress, and providing this expanded set of HLA genes is an important step in our development,” said Mr. Antovich. “Combined with our programs in companion diagnostics and genetic diseases such as Celiac Disease testing, we are building a broad offering of tests that meet the requirements of our customers.”

Linkage Biosciences Taps Vice President of Business Development

SAN FRANCISCO, California, January 17, 2011 – Linkage Biosciences announced the appointment of Matthew Frome, M.S., MPH, MBA., as Vice President of Business Development. Mr. Frome will be responsible for all sales, marketing and business development efforts, including the recently launched LinkSēq™ line of genetic testing products.

Mr. Frome has over 25 years of experience in the biotechnology arena. Most recently, he was the Director of Business Development at Solazyme, Inc, where he led the collaborative efforts with the US government for new products and with outside research organizations for new upstream technologies. Prior to Solazyme, Mr. Frome and had roles of increasing responsibility within GE Healthcare, from product management within the Molecular Dynamics group to global sales management of the Scierra product line of bioinformatic tools. Earlier in his career, he held business roles for Applied Biosytems Inc., a company delivering state of the art life science research tools and Sangamo Biosciences, a company developing engineered DNA-binding proteins for the regulation of gene expression and gene modification.

Mr. Frome holds a Master of Biological Sciences degree from Stanford University and a Masters in Public Health and Masters in Business Administration from the University of California at Berkeley.

“With the recent launch of several new products, the company is entering a new phase of development,” said Zachary Antovich, Chief Executive Officer. “Matthew brings an impressive track record, extensive experience, expertise and leadership. We are delighted to have him join the team at this time, and we are confident he will quickly make a positive impact on our business.”

Linkage Biosciences Expands HLA Menu and Adds Companion Diagnostics

SAN FRANCISCO, California, October 19, 2010 – Linkage Biosciences, Inc., a privately held molecular diagnostics company, recently announced the launch of several new products at the annual meeting of the American Society of Histocompatibility and Immunogenetics (ASHI) in Hollywood, Florida. The new products expand the LinkSēq™ HLA product line and provide additional tools for clinical transplantation, pharma, and immunogenetics research and development. The company also announced new companion diagnostic products targeting specific genetic markers.

Linkage began reaching out to the transplant and immunogenetics community last year after unveiling LinkSēq. The company is reporting a strong positive response from both domestic and international customers.

“We have been using LinkSēq since last spring and we are pleased with the results,” said Dr. David Senitzer, Histocompatibility Laboratory Director at the City of Hope Cancer Center in Duarte, California. “The simplified workflow allows our lab to be more efficient, and the software system eliminates the analysis bottle neck. We get results more quickly and this is an important point for us.”

Linkage’s new products include tests for HLA-DQ, HLA-B5701 and a genetic marker for Celiac Disease.
“Customers were asking for an HLA-DQ test,” said Zachary Antovich, CEO of Linkage Biosciences. “They were also telling us they needed to type both alpha and beta subunits (rather than beta only) so we made sure to deliver both. LinkSēq technology is the world’s first HLA typing product that takes advantage of the power of real-time PCR platforms and offers the simplest, fastest workflow available. We are excited to launch these additional products to support our customers’ needs.”

Linkage also announced new products targeting the expanding companion diagnostics market. “We are finding more interest in specific HLA typing needs for pharmacogenomics,” continued Antovich. “For example, B5701 testing is required to screen HIV patients to avoid an adverse reaction with the anti-HIV drug abacavir. The B5701 marker is also associated with liver injury caused by the antibiotic, flucloxicillin. Analogously, an HLA-DQ marker is associated with a higher risk of adverse reactions with Novartis’ osteoarthritis drug lumiracoxib.”

Linkage says the company is exploring companion diagnostic products in various areas and believes its technology is more efficient and flexible to meet both low to very high throughput needs, and these advantages ultimately translate into cost savings for customers.

LinkSēq’s innovative chemistry offers a streamlined workflow, which is a clear advantage over current molecular HLA typing products. Other HLA products rely on two techniques: a PCR amplification step followed by either gel electrophoresis or one of several probing technologies. LinkSēq is a one-step method that combines two techniques into one: PCR and fluorescence detection. After a sample is added, it is sealed and never opened again. SureTyper™ analysis software is used to automate the entire process.

Linkage Biosciences Unveils LinkSēq™ – a Revolutionary New Tool for Immunogenetic Testing

SAN FRANCISCO, California, November 18, 2009 – Linkage Biosciences, Inc., a privately held molecular diagnostics company, recently unveiled LinkSēq™ — a new one-step method for Human Leukocyte Antigen (HLA) testing — at the annual meeting of the American Society of Histocompatibility and Immunogenetics (ASHI) in San Francisco. Much faster than other HLA testing methods currently available, LinkSēq™ is a proprietary sequence-specific priming (SSP) chemistry that can be analyzed utilizing real-time PCR platforms.

“Lab professionals have been waiting for a faster method of HLA testing for years and we’re excited to be able to offer a solution that not only saves precious time and labor, but also uses equipment that many labs already own, eliminating upfront costs,” said Zachary Antovich, President and CEO of Linkage Biosciences. “We are very pleased by the positive reaction from leading medical labs to the LinkSēq™ product line and look forward to helping them achieve their goals. We are addressing a significant market opportunity for HLA testing, estimated to be in excess of $270 million globally.”

HLA genes encode cell-surface proteins that are essential elements of the immune system. These proteins are a major factor influencing immunity, autoimmunity, genetic disease, and tissue transplantation. Current methods of testing typically rely on gel electrophoresis or nucleic acid probing techniques. These methods require substantial time, labor, and skilled laboratory workers; even then, data analysis is often complicated and time consuming.

With LinkSēq™, the actual labor time is under 15 minutes with results ready in about 90 minutes, a significant improvement compared to the 4-6 hours typically required by other HLA testing methods. In addition to saving time, LinkSēq’s single step process reduces the potential for contamination since samples are handled only once and then sealed in reaction plates.
“LinkSēq™ is a major improvement in the workflow for HLA typing. I like the quick turnaround times and easy set-up; just add DNA to a tube and pipette into the reaction plate. Very straightforward,” said Dr. Elizabeth Trachtenberg, Director, HLA/Immunogenetics Laboratory, Children’s Hospital and Research Center Oakland.

LinkSēq’s innovative chemistry, an end-point PCR process, utilizes SYBR® Green to detect HLA genes. Once the PCR amplification process is completed, SYBR® Green fluorescence is detected via the real-time PCR platform to identify specific HLA genotypes. Gels and probing steps are eliminated and data analysis is simplified with the company’s SureTyper™ software, automating the entire process.

“LinkSēq™ chemistry combined with SYBR® analysis provides clear and defined results. Scale-up is easy, too, since the trays can be run on common thermal cyclers prior to analysis. This is an attractive feature,” said Dr. Shalini Pereira, Director, Clinical Immunogenetics Laboratory, Seattle Cancer Care Alliance.

Linkage Biosciences Secures Series A Financing

SAN FRANCISCO, California February 4, 2009 – Linkage Biosciences Inc., a developer of molecular diagnostic products designed to streamline complex genetic testing, has completed a Series A financing led by Greenhouse Capital Partners and James R. Fisher, managing member of Fisher Capital Corp. II LLC, a firm that works exclusively with private equity firm Kohlberg Kravis Roberts & Co..

The $2 million Series A funding round will be used to continue the development and marketing of Linkage Biosciences’ line of diagnostic products. The company’s proprietary molecular diagnostics technologies and innovations will address human leukocyte antigen (HLA) typing for organ transplantation, while further development is underway on a portfolio of products in other areas of transplantation and various complex genetic disorders.

“Our unique advantages are speed and simplicity while achieving superior accuracy,” said Zachary Antovich, president and CEO of Linkage Biosciences. “Our tests generate results much faster, with far less effort, than anything else available in the marketplace. We are pleased to have the support and experience of Greenhouse Capital and Jim Fisher as we begin to commercialize our products and expand our presence in the marketplace.”

“Linkage Biosciences’ initial testing has yielded exceptional results in tissue typing applications, and we now see the company moving to a second level of growth and development, proving that it can create an entire portfolio of molecular diagnostic products to bring to market,” said Peter Henig, managing partner of Greenhouse Capital. “We are thrilled to be an investment partner in the company’s growth and execution at this time. We believe this is an ideal time for Linkage Biosciences to initiate its market rollout strategy as the technology has surpassed significant milestones.”

The company also announced that Rebecca Bishop and Pascal Villiger have joined the Board of Directors. Ms. Bishop is currently a manager with Affymetrix, Inc. and Mr. Villiger is an investment professional within the private equity division of CalSTRS.