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Good Start Genetics Aims to Expand Reach Beyond Fertility Clinics; Build Clinical NGS Company

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Ten months after launching its sequencing-based carrier screening test, Good Start Genetics is looking to eventually market the test not only to fertility clinics, but Ob/Gyn practices, as well as move into other areas of reproductive health and build a "fully integrated clinical next-gen sequencing company," CEO Don Hardison said this week at the BIO CEO conference in New York.

The privately held company said at the conference that it brought in approximately $6 million in net revenue in 2012, and that it expects to be profitable by late third quarter of 2013 and cash flow break even by the end of the year. In December 2012, its annualized revenue reached $14 million. For full-year 2013, it is aiming to generate $25 million in revenue.

The firm is looking to raise $10 million to $15 million in financing in the first half of 2013, which will add to the $14 million it raised in April 2012 and the $18 million it raised in 2010.

Good Start expanded its testing menu in October from 14 disorders to 23, to include all those that are recommended in guidelines set by the American Congress of Obstetricians & Gynecologists, the American College of Medical Genetics and Genomics, as well as societies supporting the Ashkenazi Jewish population (CSN 10/24/2012).

Physicians can order a test encompassing the full menu of disorders or pick and choose among the 23. The company currently markets its test to a subset of the approximately 460 fertility centers in the US.

While the company does not disclose list prices of its test, which can vary depending on the diseases that are ordered, Hardison said that the company has made significant progress in obtaining reimbursement from payors. While most of the tests are reimbursed on a case-by-case basis, Hardison said that the company has also secured a couple of contracts with insurance companies. On average, payors are covering about 40 percent of the billed price. Additionally, he said Good Start's test is not any more expensive than similar carrier screening tests based on microarray technology.

He thinks that going forward, insurance companies will continue to increase coverage of the tests. He said that the company is collecting data "where we're able to show that through sequencing, we're picking up things that would have been missed" by genotyping tests based on microarray chips.

In general, the sequencing-based approach analyzes five to 10 times more variants than chip-based tests, Hardison said. Using cystic fibrosis as an example, he said most genotyping carrier screening tests for cystic fibrosis analyze around 100 variants, while Good Start's test analyzes more than 500.

The firm recently analyzed data from its first 5,545 cases, comparing its test to genotyping methods for analyzing cystic fibrosis carrier status. Of the 195 carriers the test identified, 11, or 5.6 percent, would have been missed by traditional genotyping carrier tests, Hardison said.

Those patients "got a better test that didn't cost them any more money," Hardison said. "Those kinds of things are compelling because you're showing that we are catching things that would have been missed."

Hardison said that the company is looking to expand the reach of its test beyond fertility clinics and into the Ob/Gyn space, where a lot of carrier testing is done. Because of the size of that market, however, he said that the company would be looking to forge partnerships to tap into it.

Good Start is also looking to develop other next-gen sequencing tests broadly in the area of fertility. "We're broadly interested in the whole field of fertility, whether preconception, prenatal — all of it has some interest to us," Hardison said.

For instance, he said that the company is involved in a collaboration to develop a test that would help pinpoint reasons why a couple could not get pregnant.

"It's a hot topic because people are waiting later in life to get pregnant," which can reduce the chance of conception, he said.

Additionally, Hardison said the company would consider collaborating with a third party to develop tests that would be brought through US Food and Drug Administration 510(k) clearance.

Currently, Good Start runs its carrier screening test as a laboratory-developed test out of its CLIA-certified and CAP-accredited laboratory in Cambridge, Mass. Hardison said that the company has no plans to bring that test through FDA 510(k) clearance on its own.

However, he said that other companies are interested in working with Good Start to develop content in the fertility space that the partner would then take through the FDA. In that case, Good Start would then be entitled to royalties from the kits.

Good Start also has 11 patent applications or issued patents surrounding the front end and back end of its sequencing workflow. While the company currently uses Illumina's HiSeq platform for the sequencing, Hardison said that it is essentially platform agnostic, and is always looking at other sequencing technology.

For its purposes, he said the number one criteria for a sequencing platform is accuracy, followed by cost, efficiency, and turnaround time. "We have to be accurate," he said. "We've gone through a lot of validation to prove that we can produce a diagnostic grade test. We believe we're as accurate as we can be," he said.

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