Linkage Biosciences

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."

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."

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."

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."

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.

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.

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.