Leaders in the Laboratory

Biocare Medical

If the story of David and Goliath teaches us anything; it is that the quick and nimble can outwit, outsmart and challenge the mightiest of giants. Physical strength and size can only take you so far; it takes an intelligent, sophisticated approach to win the battle.

Biocare Medical is a small, up and coming company, headquartered in Northern California with approximately 40 sales, service and support people in the field. The company performs Research and Development as well as Manufacturing of cancer diagnostic reagents and equipment. We spoke with Roy Paxton Yih, the company’s President and CEO, along with Dr. David Tacha, CSO and VP of R&D, and Dr. Rhonda Henshall-Powell, Director of Marketing & Education, who were happy to share what makes Biocare a market leader in its field.

Biocare Medical was founded in 1997 by Roy Paxton Yih, Dr. David Tacha and Gene Castagnini. Based on a passion for patient care, the company has employed a visionary team of R&D experts to develop and patent its innovative products and has blazed a trail through some very advanced fields. The team’s use of Multiplex IHC testing is a great example of this. Multiple detection platforms enable simultaneous Multiplex IHC staining with multiple antibodies on a single slide. “This detection system simplifies procedures and reduces turnaround time,” the company explains.

“We can have multiple colours within a tumour cell and aid the determination of whether it’s benign or malignant, low risk or high risk,” explains Dr. Tacha. “It’s called simultaneous Multiplex IHC, where we can take up to five antibodies and using two or three colours, reveal insightful information.”

Many biopsies have such little tissue that you only have one or two chances; Multiplex IHC testing cuts down the time it takes to diagnose and limits the amount of tissue needed.

Biocare Medical was the first to bring this technology to the clinical market. There had been some variation of it in fluorescent form in the research market, but it had never before been brought to the level of accuracy needed for a clinical diagnostic lab. The company recently acquired the patent for this technology.

“It is our #1 product. The PIN 4™ Multiplex IHC (Patented) is now a standard procedure used for prostate biopsies. It is used not only domestically, but worldwide. Even before the patent, we stood alone; we had no competition, as they could not reproduce our protocols. We have always been a leader with this technology.”

All of Biocare Medical’s reagents can be ordered online. The company also possesses the patents and licenses for a number of antibodies including p63, p40 and ERG. Partnered with Ventana, Biocare has the exclusive rights to p63. Add to that the patent rights on p40; an antibody that is taking the world by storm… p40 is a much more specific antibody that can be used in place of p63for lung cancer. Patents are also pending on PAX8, for kidney and ovarian cancer, Uroplakin II for bladder cancer and SOX10 for melanoma.

The new PAX8 monoclonal antibody is replacing other PAX8 antibodies in the field that are shown to cross-react with several other types of cancer and also stains B cells, making it difficult to use in the diagnosis in lymph nodes. “The vision we have is to look at these antibodies that are utilized in the field that are poor quality polyclonals and raise the standard up to a very accurate and precise diagnostic tool.

“Today we are one of the few companies that really have these antibodies and are actively marketing them. We also collaborate on publications – several on PAX8, three on Uroplakin II, one on p40 and several minor ones on SOX10, with one just accepted in the Archives of Pathology Journal.” In addition, Biocare Medical has another Multiplex IHC called ADH-5™, which uses five different antibodies and looks at the difference between benign, atypical hyperplasia, invasive carcinoma and what is called the basal phenotype in breast cancer. In one stain the pathologist can actually discriminate five different subtypes of breast cancer.

Further to that, Biocare Medical has an exclusive worldwide license to the monoclonal antibody named ERG. This is a remarkable antibody that detects a chromosomal translocation-fusion which is almost 100 percent specific to the prostate. “They have now determined that ERG and those other types of markers such as PTEN are highly prognostic and predictive.”

These antibodies are critical to not only determine the sub-types of cancer and what may be causing the cancer, but also for what is called “risk stratification. We look at the ERG, and then determine if there are other suppressor genes deleted, such as NKX3.1 or PTEN. In certain grading scores of cancer, this is critically important for determining what kind of treatment needs to be given. “These are all products we are working on now; many of them are currently available for sale. We call these our premier antibodies.”

Under the pioneering direction of Dr. David Tacha, the company’s R&D department seems to be working around the clock these days; developing and honing expertise with a number of new, in-house technologies.

“They are an excellent group of scientists, with very technical expertise,” Dr. Tacha says of the Biocare R&D team. “They are able to put together complex protocols for immunohistochemistry (IHC), in situ hybridization (ISH) or fluorescence in situ hybridization (FISH). Biocare has the innate ability for making quite complex techniques accessible and simple for any laboratory to use.” All of this in-house technology represents unique intellectual property for which patents have been applied.

To be sure, the broader industry recognizes Biocare Medical as a team of pioneers and this will continue on with the newer innovative products currently under development. The predictive aspect is very important; in cancer, there is a stage in which it is a bit of a no man’s land – 50 percent of patients respond and 50 percent don’t. Biocare Medical is pioneering the prognostic market by providing pathologists with the right tools, to aid in the detection and diagnosis to make the appropriate course of action clearer.

It doesn’t end there. The company has recently released the aforementioned SOX10 mouse monoclonal antibody. SOX10 is an innovative antibody for dermatopathology used in the diagnosis of melanoma. “One of the problems with melanoma is that there were certain subtypes that were negative for the antibodies that are currently available. SOX10 does not stain non-melanoma mimics, which could lead to a false positive diagnosis, and so becomes very important.” This kind of antibody is in high demand and has been needed for some time.

The bottom line is that these antibodies presently out in the field are simply not as clean. Biocare Medical is the first to bring this exceptionally clean, optimized SOX10 (M) antibody to the market. “The alternatives are called polyclonal antibodies, they were not only inferior – they were horrible!” says Dr. Tacha. Biocare was the first to develop a mouse monoclonal SOX10, which is virtually background free, and offer it as a Class 1 in vitro diagnostic (IVD). Competing antibodies were only available for research use only (RUO) and are far inferior in performance.

What all of this boils down to is the ultimate in patient care through the best tools possible. Biocare Medical has a very strong vision for early diagnosis and strives to ensure that it is accurate. With early diagnosis, treatment is that much more likely to be successful.

“The patient diagnosis is more accurate, consistent and innovative,” says Dr. Tacha. “We stand by our slogan – ‘We are fighting cancer one slide at a time.’ This is taken literally and very seriously. We are a very technical company, but it’s the passion and the drive of the three founders that really brings the company to fruition.”

Biocare Medical truly believes that its team has some of the best technology available and the company consistently aims to explore further. Further proof of its dedication can be seen through the efforts of the sales team and employees. They are encouraged to keep patients close and to keep visuals of people that are battling cancer within sight daily. The patients, after all, are the reason the team strives for perfection with such superior quality products.

“That is why we are recognized by the industry… it is because we care. That is the bottom line… Our competition is 10, 20, 30 times larger than we are, but we are the ones that stand out. It is because we do have that underlying motivation of patient care.”

For more information about Biocare Medical, please visit http://biocare.net/

November 19, 2017, 3:30 AM EST